Parkinson's Disease
Conditions
Keywords
transcranial direct current stimulation, neuromodulation
Brief summary
This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.
OTHERlocomotor training
An individualized dual-task walking program for approximately 30 minutes.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age 18- 80 2. Parkinson's disease stages 2-3 Hoehn and Yahr. 3. Presence of Freezing of Gait 4. Stable medication regimen 5. Time to complete TUG \>12 seconds
Exclusion criteria
1. medical condition that would interfere with walking and training for 30 minutes 2. unable to perform timed up and go in the off condition 3. history of seizures 4. implanted deep brain stimulator, pacemaker or any other electronic device. 5. dementia 6. Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed | baseline, 3 weeks | walking speed will be measured using sensors during a 90 second walk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stride Length | baseline, 3 weeks | Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk. |
| Change in Postural Sway | baseline, 3 weeks | Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing. |
| Change in Timed Up-and-Go (TUG) Time | baseline, 3 weeks | Participants are timed while standing up from a chair, walking around a cone, and returning to their chair. |
| Change in Motor Threshold | baseline, 3 weeks | Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand. |
| Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio | baseline, 3 weeks | Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS). |
| Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS) | baseline, 3 weeks | UPDRS motor score range from 0-56 with higher scores indicating greater impairment. |
| Change in the Trail Making Test Time | baseline, 3 weeks | Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment. |
| Change in the Montreal Cognitive Assessment (MOCA) | baseline, 3 weeks | The MOCA has a total score ranging from 0-30 with a higher score indicating better performance. |
| Change in the Auditory Consonant Trigrams Test (ACT) | baseline, 3 weeks | The ACT has a score from 0-60 with higher score indicating better performance. |
| Change in the Freezing of Gait Questionnaire (FOG-Q) | baseline, 3 weeks | The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing. |
| Change in Backward Digit Span | baseline, 3 weeks | Digit span is measured by total number of correct digits recited. |
Countries
United States
Participant flow
Recruitment details
One participant was removed from the study and re-enrolled. However, this participant did not complete the study intervention on their first or second enrollment. Therefore their data has not been included in any of the outcome measures.
Participants by arm
| Arm | Count |
|---|---|
| tDCS+ LT Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.
Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.
locomotor training: An individualized dual-task walking program for approximately 30 minutes. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | unrelated adverse event | 1 |
Baseline characteristics
| Characteristic | tDCS+ LT |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 1 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
Change in Walking Speed
walking speed will be measured using sensors during a 90 second walk
Time frame: baseline, 3 weeks
Population: Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in Walking Speed | 0.169 m/s | Standard Deviation 0.244 |
Secondary
Change in Backward Digit Span
Digit span is measured by total number of correct digits recited.
Time frame: baseline, 3 weeks
Population: No data was collected for this outcome measure.
Secondary
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).
Time frame: baseline, 3 weeks
Population: No data was collected for this outcome measure.
Secondary
Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
UPDRS motor score range from 0-56 with higher scores indicating greater impairment.
Time frame: baseline, 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS) | -1.714 score on a scale | Standard Deviation 14.088 |
Secondary
Change in Motor Threshold
Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.
Time frame: baseline, 3 weeks
Population: 3-week data not collected for 5 participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in Motor Threshold | -0.005 percentage of TMS output | Standard Deviation 0.021 |
Secondary
Change in Postural Sway
Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.
Time frame: baseline, 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in Postural Sway | -0.012 m^2/s^5 | Standard Deviation 0.009 |
Secondary
Change in Stride Length
Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
Time frame: baseline, 3 weeks
Population: Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in Stride Length | 0.127 m | Standard Deviation 0.239 |
Secondary
Change in the Auditory Consonant Trigrams Test (ACT)
The ACT has a score from 0-60 with higher score indicating better performance.
Time frame: baseline, 3 weeks
Population: No data was collected for this outcome measure.
Secondary
Change in the Freezing of Gait Questionnaire (FOG-Q)
The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.
Time frame: baseline, 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in the Freezing of Gait Questionnaire (FOG-Q) | -4.29 score on a scale | Standard Deviation 3.21 |
Secondary
Change in the Montreal Cognitive Assessment (MOCA)
The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.
Time frame: baseline, 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in the Montreal Cognitive Assessment (MOCA) | 2.57 score on a scale | Standard Deviation 1.89 |
Secondary
Change in the Trail Making Test Time
Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.
Time frame: baseline, 3 weeks
Population: No data was collected for this outcome measure.
Secondary
Change in Timed Up-and-Go (TUG) Time
Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.
Time frame: baseline, 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS+ LT | Change in Timed Up-and-Go (TUG) Time | -6.878 seconds | Standard Deviation 4.268 |