Asymmetric Targeted DBS for PD With PIGD (ATS-PIGD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Deep brain stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Dianyou Li, MD, PhD; Email: ldy11483@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-GPi/R-STN; Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year.	Device: Deep brain stimulation; active DBS with optimal stimulating parameters
Active Comparator: Bi-STN; Participants randomized in this arm will receive bilateral STN stimulation for 1 year.	Device: Deep brain stimulation; active DBS with optimal stimulating parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in completion time on the Timed Up and Go test at 12 months	in the off-medication condition	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	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	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	Baseline and 6 months
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).	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).	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).	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).	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).	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).	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).	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).	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).	Baseline and 6 months
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	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.	Baseline and 12 months
Change from Baseline in dysphonia severity index (DSI) at 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.	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).	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).	Baseline and 6 months
Adverse events		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).	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	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months
Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months
Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months
Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months
Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months
Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months
Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 12 months
Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months	In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: deep brain stimulation; subthalamic nucleus; postural instability/gait difficulty; globus pallidus internus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Asym Stim-PIGD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No