Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-02

Brief Summary

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The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients.

In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.

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Detailed Description

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Conditions

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Parkinson Disease Deep Brain Stimulation Globus Pallidus Interna Subthalamic Nucleus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Throughout the study, all participants, independent raters/evaluators and statisticians will be blind to the treatment conditions and parameter configurations. Independent raters who are blind to the conditions will be responsible for the conduct of all the assessments. Participants are blind to the treatment conditions. Movement disorders clinician responsible for programming are blind to the study protocol. They are simply told to adjust parameter to optimize therapeutic effects.

Study Groups

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Unilateral DBS of the subthalamic nucleus (STN)

To deliver unilateral STN DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral STN DBS. The STN stimulation will be programmed as previous parameter configuration with optimal therapeutic benefits. Participants will be asked to complete a comprehensive set of assessments under unilateral STN stimulation in the off-medication state. 45 minutes after taking regular medication, participants need to complete the second set of assessments in the on-medication state.

Group Type EXPERIMENTAL

DBS

Intervention Type PROCEDURE

Unilateral DBS for treatment of patients with PD

Unilateral DBS of the globus pallidus interna (GPi)

To deliver unilateral GPi DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral GPi DBS. The study protocol is identical to the intervention of unilateral STN DBS but it was done on a different day.

Group Type EXPERIMENTAL

DBS

Intervention Type PROCEDURE

Unilateral DBS for treatment of patients with PD

Interventions

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DBS

Unilateral DBS for treatment of patients with PD

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with idiopathic Parkinson's disease
* Aged between 55 and 75 years, both male and female
* Patients who have undergone combined unilateral STN and contralateral GPi DBS for more than 6 months
* A Hoehn-Yahr (H-Y) stage of less than 4 in the off-medication state
* A left-extremity to right-extremity ratio of less than 0.15 on the Unified Parkinson's Disease Rating Scale part Ⅲ (UPDRS-Ⅲ) in the both off-medication and on-medication states

Exclusion Criteria

* History of serious psychosis
* History of intractable epilepsy (i.e., seizures)
* Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
* Dementia (A Mini-Mental State Examination (MMSE) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
* Lack of cooperation
* Additional reasons for exclusion at the discretion of the clinical investigator
* Poorly controlled depression or anxiety
* Past history of suicidal attempt

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No