Clinical trial NCT05397340: Asymmetric Targeted DBS for PD With PIGD
Official title: Deep Brain Stimulation of Asymmetric Targets Versus Bilateral Subthalamic Nucleus (STN) for Parkinson's Disease With Postural Instability/Gait Difficulty: a Prospective, Randomized, Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: postural instability/gait difficulty
deep brain stimulation
subthalamic nucleus
globus pallidus internus
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from Baseline in completion time on the Timed Up and Go test at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in completion time on the Timed Up and Go test at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in the number of steps on the Timed Up and Go test at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in the number of steps on the Timed Up and Go test at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in maximal phonatory time at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in maximal phonatory time at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in dysphonia severity index (DSI) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in dysphonia severity index (DSI) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months
timeFrame: Baseline and 6 months
measure: Adverse events
timeFrame: up to 12 months after surgery
measure: Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months
timeFrame: Baseline and 6 months
Other outcomes:
measure: Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
measure: Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
timeFrame: Baseline and 6 months
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Dianyou Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: