Asymmetric Targeted DBS for PD With PIGD
- Conditions
- Parkinson Disease
- Interventions
- Device: Deep brain stimulation
- Registration Number
- NCT05397340
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- diagnosis of idiopathic Parkinson's disease
- postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L-GPi/R-STN Deep brain stimulation Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year. Bi-STN Deep brain stimulation Participants randomized in this arm will receive bilateral STN stimulation for 1 year.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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 6 months Baseline and 6 months The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).
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 medication usage on the Levodopa Equivalent Daily Dose at 6 months Baseline and 6 months 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 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 maximal phonatory time at 12 months Baseline and 12 months 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 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 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).
Trial Locations
- Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China