Parkinson Disease
Conditions
Keywords
postural instability/gait difficulty, deep brain stimulation, subthalamic nucleus, globus pallidus internus
Brief summary
The purpose of this study is to compare the effectiveness of the deep brain stimulation of asymmetric targets \[subthalamic nucleus (STN) in the right hemisphere while globus pallidus interna (GPi) in the left\] versus the bilateral STN for the treatment of Parkinson's disease (PD) with postural instability/gait difficulty (PIGD) in a randomized, double-blinded manner.
Detailed description
This is a double-blinded, randomized, controlled trial aiming at comparing the efficacy of asymmetric targets and bilateral STN DBS in treating PD with PIGD. After being informed about the study and potential risks, enrolled patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio using a minimization randomization method in a double-blinded manner, and later undergo bilateral DBS surgery. One group of patients will receive stimulation of left GPi and right STN, while the other will receive STN stimulation bilaterally. The follow-up period will be one year, with corresponding clinical assessments completed at six months and one year postoperatively.
Interventions
DEVICEDeep brain stimulation
active DBS with optimal stimulating parameters
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of idiopathic Parkinson's disease * postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition
Exclusion criteria
* Atypical parkinsonism * History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery * Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent * Presence of anatomical abnormalities in the target region * Clinically significant medical history that would increase pre-/post-operative complications * Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months | Baseline and 12 months | In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms). |
| Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months | Baseline and 12 months | in the off-medication condition |
| Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 12 months | Baseline and 12 months | In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | up to 12 months after surgery | — |
| Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months | Baseline and 12 months | The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia). |
| Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 6 months | Baseline and 6 months | The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia). |
| Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months | Baseline and 12 months | The scores could range from 0 (no gait impairment) to 64 (severe gait impairment). |
| Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 6 months | Baseline and 6 months | The scores could range from 0 (no gait impairment) to 64 (severe gait impairment). |
| Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months | Baseline and 12 months | — |
| Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months | Baseline and 6 months | — |
| Change from Baseline in maximal phonatory time at 12 months | Baseline and 12 months | — |
| Change from Baseline in maximal phonatory time at 6 months | Baseline and 6 months | — |
| Change from Baseline in dysphonia severity index (DSI) at 12 months | Baseline and 12 months | DSI=0.13 x MPT + 0.0053 x F-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4. The DSI for perceptually normal voices equals +5 and for severely dysphonic voices -5. The more negative the patient's index is, the worse is his or her vocal quality. |
| Change from Baseline in dysphonia severity index (DSI) at 6 months | Baseline and 6 months | DSI=0.13 x MPT + 0.0053 x F-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4. The DSI for perceptually normal voices equals +5 and for severely dysphonic voices -5. The more negative the patient's index is, the worse is his or her vocal quality. |
| Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months | Baseline and 12 months | The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment). |
| Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months | Baseline and 6 months | The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment). |
| Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months | Baseline and 6 months | In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem). |
| Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months | Baseline and 6 months | in the off-medication condition |
| Change from Baseline in completion time on the Timed Up and Go test at 12 months | Baseline and 12 months | in the off-medication condition |
| Change from Baseline in completion time on the Timed Up and Go test at 6 months | Baseline and 6 months | in the off-medication condition |
| Change from Baseline in the number of steps on the Timed Up and Go test at 12 months | Baseline and 12 months | in the off-medication condition |
| Change from Baseline in the number of steps on the Timed Up and Go test at 6 months | Baseline and 6 months | in the off-medication condition |
| Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months | Baseline and 6 months | In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms). |
| Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months | Baseline and 12 months | The scores could range from 0 (no balance confidence) to 100 (good balance confidence). |
| Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 6 months | Baseline and 6 months | The scores could range from 0 (no balance confidence) to 100 (good balance confidence). |
| Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months | Baseline and 12 months | The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait). |
| Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 6 months | Baseline and 6 months | The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months | Baseline and 12 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
| Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months | Baseline and 6 months | In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test. |
Countries
China
Contacts
Primary ContactDianyou Li, MD, PhD
Outcome results
None listed