Parkinson's Disease
Conditions
Keywords
DBS, Low frequency stimulation, Dysphagia, Freezing of gait
Brief summary
Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that bilateral STN DBS of 60Hz, compared to the traditional 130Hz, decreased the aspiration frequency and swallowing difficulty, freezing of gait (FOG), and other axial symptoms and parkinsonism in Parkinson patients with FOG refractory to 130Hz and medications. The benefit of 60Hz stimulation persisted during the 6-week study period, but with worsening tremor in one patient. However, it remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period, and whether there is carry-over effect across different conditions. Hence, the investigators would like to test the hypothesis that the 60Hz stimulation, compared to 130Hz might have persistent benefit over an extended period in reducing the swallowing dysfunction, FOG, and other axial symptoms in these PD patients even after correcting the potential carry-over effect.
Detailed description
The investigators will enroll 14 Parkinson patients with bilateral STN DBS and refractory FOG to 130Hz stimulation and dopaminergic medications for two visits of at least 6-month apart. The 6 patients remaining on 60Hz stimulation after our previous study consisting of 7 patients will be assessed once again as visit-2 after previous visit-1 of their last study. We anticipate to have 20 patents complete for visit-1 and at least 18 patients complete for visit-2 in this randomized double-blind prospective crossover study with their usual medication on state, with 6-7 patients on each starting condition (60Hz vs 130Hz vs DBS off). Swallowing function on modified barium swallowing test and swallowing questionnaire, FOG in stand-walk-sit test and questionnaire, and other axial and motor function on UPDRS-III will be assessed under each DBS condition. Changes in measurements between 60Hz and 130Hz at each visit and under 60Hz between two visits will be analyzed, with swallowing function and FOG as primary, and the rest as secondary outcomes, correcting for potential carryover effect. Changes between other DBS conditions might also be explored in this 2-year study. This would be the first study on the long-term effect of 60Hz stimulation on dysphagia, FOG and other axial and motor symptoms in Parkinson patients with bilateral STN DBS and FOG refractory to 130Hz stimulation and dopaminergic medications, which will have significant impact on the treatment of difficult axial symptoms of high morbidity and mortality.
Interventions
DEVICEDeep Brain Stimulation (DBS) at 60 Hz
Bilateral subthalamic nucleus deep brain stimulation at 60 Hz
DEVICEDeep Brain Stimulation (DBS) at 130 Hz
Bilateral subthalamic nucleus deep brain stimulation at 130 Hz
DEVICEDeep Brain Stimulation (DBS) Off (Sham)
Deep Brain Stimulation (DBS) Off (Sham)
Sponsors
Michael J. Fox Foundation for Parkinson's Research
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication on state.
Exclusion criteria
* Known history of recent aspiration pneumonia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stand-Walk-Sit Time at Visit 2 | Immediately following treatment for at least 30 minutes | Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms. |
| Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 | Immediately following treatment for at least 30 minutes | A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration & a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to 0 if PAS score was under 6 or 1 if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid & food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function. |
| Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1 | Immediately following treatment for at least 30 minutes | The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance. |
| Freezing of Gait Questionnaire at Visit 1 | Immediately following treatment for at least 30 minutes | The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG. |
| Stand-Walk-Sit Freezing of Gait Spells at Visit 1 | Immediately following treatment for at least 30 minutes | The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms. |
| Stand-Walk-Sit Time at Visit 1 | Immediately following treatment for at least 30 minutes | Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms. |
| Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2 | Immediately following treatment for at least 30 minutes | A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration & a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to 0 if PAS score was under 6 or 1 if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid & food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function. |
| Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2 | Immediately following treatment for at least 30 minutes | The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance. |
| Freezing of Gait Questionnaire at Visit 2 | Immediately following treatment for at least 30 minutes | The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG. |
| Stand-Walk-Sit Freezing of Gait Spells at Visit 2 | Immediately following treatment for at least 30 minutes | The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1 | Immediately following treatment for at least 30 minutes | Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism. |
| Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | Immediately following treatment for at least 30 minutes | The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture. |
| Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | Immediately following treatment for at least 30 minutes | The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement. |
| Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | Immediately following treatment for at least 30 minutes | The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity. |
| Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | Immediately following treatment for at least 30 minutes | The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor. |
| Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2 | Immediately following treatment for at least 30 minutes | Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism. |
| Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | Immediately following treatment for at least 30 minutes | The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture. |
| Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | Immediately following treatment for at least 30 minutes | The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement. |
| Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | Immediately following treatment for at least 30 minutes | The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity. |
| Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | Immediately following treatment for at least 30 minutes | The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor. |
Countries
United States
Participant flow
Recruitment details
15 patients were screened for eligibility at a hospital-associated specialty clinic in Chicago, IL.
Pre-assignment details
Eleven of 15 screened participants were enrolled; four did not meet inclusion/exclusion criteria. Five of the enrolled participants had participated in a previous study and had been treated on 60Hz DBS since then; their Visit 1 (V1) measurements were taken from the previous study.
Participants by arm
| Arm | Count |
|---|---|
| Deep Brain Stimulation (DBS) All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Long-term 60 Hz DBS | Study Closed | 1 |
Baseline characteristics
| Characteristic | Deep Brain Stimulation (DBS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| DBS at High Frequency Stimulation Duration | 3.5 years STANDARD_DEVIATION 4 |
| Parkinson's Disease Duration | 14.2 years STANDARD_DEVIATION 5.7 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 0 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 participants |
| Race/Ethnicity, Customized White, non-Hispanic | 6 participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Freezing of Gait Questionnaire at Visit 1
The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Freezing of Gait Questionnaire at Visit 1 | 3.0 score on a scale | Standard Deviation 3.7 |
| DBS 130Hz | Freezing of Gait Questionnaire at Visit 1 | 9.3 score on a scale | Standard Deviation 4.1 |
| DBS Off | Freezing of Gait Questionnaire at Visit 1 | 5.1 score on a scale | Standard Deviation 3.8 |
p-value: <0.01Paired t-test, 2 sided
Primary
Freezing of Gait Questionnaire at Visit 2
The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Freezing of Gait Questionnaire at Visit 2 | 5.9 score on a scale | Standard Deviation 4.4 |
| DBS 130Hz | Freezing of Gait Questionnaire at Visit 2 | 11.2 score on a scale | Standard Deviation 4.1 |
| DBS Off | Freezing of Gait Questionnaire at Visit 2 | 7.0 score on a scale | Standard Deviation 4 |
p-value: <0.01Paired t-test, 2 sided
Primary
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1
A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration & a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to 0 if PAS score was under 6 or 1 if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid & food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 | 0.6 score on a scale | Standard Deviation 0.8 |
| DBS 130Hz | Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 | 2.9 score on a scale | Standard Deviation 2.1 |
| DBS Off | Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 | 1.2 score on a scale | Standard Deviation 1.7 |
p-value: <0.05Paired t-test, 2 sided
Primary
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2
A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration & a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to 0 if PAS score was under 6 or 1 if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid & food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2 | 2.0 score on a scale | Standard Deviation 2.4 |
| DBS 130Hz | Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2 | 3.0 score on a scale | Standard Deviation 2.5 |
| DBS Off | Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2 | 2.4 score on a scale | Standard Deviation 2.6 |
p-value: >0.05Paired t-test, 2 sided
Primary
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1
The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1 | 1.1 score on a scale | Standard Deviation 1 |
| DBS 130Hz | Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1 | 3.3 score on a scale | Standard Deviation 2.1 |
| DBS Off | Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1 | 3.1 score on a scale | Standard Deviation 1.9 |
p-value: <0.01Paired t-test, 2 sided
Primary
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2
The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2 | 4.8 score on a scale | Standard Deviation 6.9 |
| DBS 130Hz | Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2 | 7.4 score on a scale | Standard Deviation 8.9 |
| DBS Off | Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2 | 5.7 score on a scale | Standard Deviation 6.9 |
p-value: >0.05Paired t-test, 2 sided
Primary
Stand-Walk-Sit Freezing of Gait Spells at Visit 1
The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Stand-Walk-Sit Freezing of Gait Spells at Visit 1 | 0.1 score on a scale | Standard Deviation 0.2 |
| DBS 130Hz | Stand-Walk-Sit Freezing of Gait Spells at Visit 1 | 3.0 score on a scale | Standard Deviation 3.8 |
| DBS Off | Stand-Walk-Sit Freezing of Gait Spells at Visit 1 | 1.6 score on a scale | Standard Deviation 1.6 |
p-value: >0.05Paired t-test, 2 sided
Primary
Stand-Walk-Sit Freezing of Gait Spells at Visit 2
The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Stand-Walk-Sit Freezing of Gait Spells at Visit 2 | 2.2 score on a scale | Standard Deviation 3.8 |
| DBS 130Hz | Stand-Walk-Sit Freezing of Gait Spells at Visit 2 | 6.1 score on a scale | Standard Deviation 7 |
| DBS Off | Stand-Walk-Sit Freezing of Gait Spells at Visit 2 | 2.5 score on a scale | Standard Deviation 2.8 |
p-value: <0.05Paired t-test, 2 sided
Primary
Stand-Walk-Sit Time at Visit 1
Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Stand-Walk-Sit Time at Visit 1 | 22.1 seconds | Standard Deviation 7.1 |
| DBS 130Hz | Stand-Walk-Sit Time at Visit 1 | 28.5 seconds | Standard Deviation 8.5 |
| DBS Off | Stand-Walk-Sit Time at Visit 1 | 23.6 seconds | Standard Deviation 6 |
p-value: <0.05Paired t-test, 2 sided
Primary
Stand-Walk-Sit Time at Visit 2
Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Stand-Walk-Sit Time at Visit 2 | 26.5 seconds | Standard Deviation 12.2 |
| DBS 130Hz | Stand-Walk-Sit Time at Visit 2 | 38.4 seconds | Standard Deviation 26 |
| DBS Off | Stand-Walk-Sit Time at Visit 2 | 27.8 seconds | Standard Deviation 11.9 |
p-value: >0.05Paired t-test, 2 sided
Secondary
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 3.8 score on a scale | Standard Deviation 3.3 |
| DBS 130Hz | Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 8.9 score on a scale | Standard Deviation 3.4 |
| DBS Off | Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 6.9 score on a scale | Standard Deviation 4.4 |
p-value: <0.001Paired t-test, 2 sided
Secondary
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 6.8 score on a scale | Standard Deviation 4.7 |
| DBS 130Hz | Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 10.4 score on a scale | Standard Deviation 3.9 |
| DBS Off | Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 8.1 score on a scale | Standard Deviation 4 |
p-value: <0.05Paired t-test, 2 sided
Secondary
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 11.7 score on a scale | Standard Deviation 5.3 |
| DBS 130Hz | Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 16.6 score on a scale | Standard Deviation 4.6 |
| DBS Off | Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 17.1 score on a scale | Standard Deviation 5 |
p-value: <0.05Paired t-test, 2 sided
Secondary
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 12.8 score on a scale | Standard Deviation 3.5 |
| DBS 130Hz | Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 16.3 score on a scale | Standard Deviation 2.3 |
| DBS Off | Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 15.7 score on a scale | Standard Deviation 3.7 |
p-value: <0.05Paired t-test, 2 sided
Secondary
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 4.0 score on a scale | Standard Deviation 2.4 |
| DBS 130Hz | Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 4.9 score on a scale | Standard Deviation 2.5 |
| DBS Off | Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 6.0 score on a scale | Standard Deviation 3.1 |
p-value: >0.05Paired t-test, 2 sided
Secondary
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 4.3 score on a scale | Standard Deviation 2.2 |
| DBS 130Hz | Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 3.8 score on a scale | Standard Deviation 2.1 |
| DBS Off | Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 4.8 score on a scale | Standard Deviation 2.4 |
p-value: >0.05Paired t-test, 2 sided
Secondary
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 1.8 score on a scale | Standard Deviation 2.2 |
| DBS 130Hz | Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 1.2 score on a scale | Standard Deviation 2.1 |
| DBS Off | Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 | 2.5 score on a scale | Standard Deviation 3.4 |
p-value: >0.05Paired t-test, 2 sided
Secondary
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 1.6 score on a scale | Standard Deviation 2.6 |
| DBS 130Hz | Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 0.2 score on a scale | Standard Deviation 0.7 |
| DBS Off | Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 | 1.2 score on a scale | Standard Deviation 2 |
p-value: >0.05Paired t-test, 2 sided
Secondary
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1
Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1 | 22.8 score on a scale | Standard Deviation 10.4 |
| DBS 130Hz | Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1 | 33.7 score on a scale | Standard Deviation 8.3 |
| DBS Off | Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1 | 34.4 score on a scale | Standard Deviation 12.1 |
p-value: <0.01Paired t-test, 2 sided
Secondary
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2
Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.
Time frame: Immediately following treatment for at least 30 minutes
Population: Participants completing Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DBS 60Hz | Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2 | 27.1 score on a scale | Standard Deviation 9.1 |
| DBS 130Hz | Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2 | 32.4 score on a scale | Standard Deviation 7.1 |
| DBS Off | Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2 | 31.4 score on a scale | Standard Deviation 10.1 |
p-value: <0.05Paired t-test, 2 sided