Asymmetric Targeted DBS for PD With PIGD

Ruijin Hospital40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

Deep brain stimulationDEVICE

active DBS with optimal stimulating parameters

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months

In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).

Time frame: Baseline and 12 months

Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 12 months

In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).

Time frame: Baseline and 12 months

Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months

in the off-medication condition

Time frame: Baseline and 12 months

Secondary Outcomes

Change from Baseline in completion time on the Timed Up and Go test at 12 months

in the off-medication condition

Time frame: Baseline and 12 months

Change from Baseline in completion time on the Timed Up and Go test at 6 months

in the off-medication condition

Time frame: Baseline and 6 months

Change from Baseline in the number of steps on the Timed Up and Go test at 12 months

in the off-medication condition

Time frame: Baseline and 12 months

Change from Baseline in the number of steps on the Timed Up and Go test at 6 months

in the off-medication condition

Time frame: Baseline and 6 months

Central Contacts

Dianyou Li, MD, PhD

CONTACT

+0086-021-64370045 ldy11483@rjh.com.cn

Data from ClinicalTrials.gov

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Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months

In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).

Time frame: Baseline and 6 months

Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months

The scores could range from 0 (no balance confidence) to 100 (good balance confidence).

Time frame: Baseline and 12 months

Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 6 months

The scores could range from 0 (no balance confidence) to 100 (good balance confidence).

Time frame: Baseline and 6 months

Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months

The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).

Time frame: Baseline and 12 months

Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 6 months

The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).

Time frame: Baseline and 6 months

Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months

The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia).

Time frame: Baseline and 12 months

Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 6 months

The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia).

Time frame: Baseline and 6 months

Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months

The scores could range from 0 (no gait impairment) to 64 (severe gait impairment).

Time frame: Baseline and 12 months

Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 6 months

The scores could range from 0 (no gait impairment) to 64 (severe gait impairment).

Time frame: Baseline and 6 months

Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months

Time frame: Baseline and 12 months

Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months

Time frame: Baseline and 6 months

Change from Baseline in maximal phonatory time at 12 months

Time frame: Baseline and 12 months

Change from Baseline in maximal phonatory time at 6 months

Time frame: Baseline and 6 months

Change from Baseline in dysphonia severity index (DSI) at 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.

Time frame: Baseline and 12 months

Change from Baseline in dysphonia severity index (DSI) at 6 months

Time frame: Baseline and 6 months

Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months

The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment).

Time frame: Baseline and 12 months

Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months

The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment).

Time frame: Baseline and 6 months

Adverse events

Time frame: up to 12 months after surgery

Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months

In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).

Time frame: Baseline and 6 months

Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months

in the off-medication condition

Time frame: Baseline and 6 months