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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring postural instability/gait difficulty, deep brain stimulation, subthalamic nucleus, globus pallidus internus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-GPi/R-STN

Bi-STN

Arm Description

Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year.

Participants randomized in this arm will receive bilateral STN stimulation for 1 year.

Outcomes

Primary Outcome Measures

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).
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).
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
in the off-medication condition

Secondary Outcome Measures

Change from Baseline in completion time on the Timed Up and Go test at 12 months
in the off-medication condition
Change from Baseline in completion time on the Timed Up and Go test at 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
in the off-medication condition
Change from Baseline in the number of steps on the Timed Up and Go test at 6 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
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
The scores could range from 0 (no balance confidence) to 100 (good balance confidence).
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).
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).
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).
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).
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).
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).
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).
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months
Change from Baseline in maximal phonatory time at 12 months
Change from Baseline in maximal phonatory time at 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.
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.
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).
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).
Adverse events
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).
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months
in the off-medication condition

Full Information

First Posted
May 18, 2022
Last Updated
January 19, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05397340
Brief Title
Asymmetric Targeted DBS for PD With PIGD
Acronym
ATS-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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
postural instability/gait difficulty, deep brain stimulation, subthalamic nucleus, globus pallidus internus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-GPi/R-STN
Arm Type
Experimental
Arm Description
Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year.
Arm Title
Bi-STN
Arm Type
Active Comparator
Arm Description
Participants randomized in this arm will receive bilateral STN stimulation for 1 year.
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
active DBS with optimal stimulating parameters
Primary Outcome Measure Information:
Title
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
Description
In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Time Frame
Baseline and 12 months
Title
Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 12 months
Description
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
Title
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
Description
in the off-medication condition
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in completion time on the Timed Up and Go test at 12 months
Description
in the off-medication condition
Time Frame
Baseline and 12 months
Title
Change from Baseline in completion time on the Timed Up and Go test at 6 months
Description
in the off-medication condition
Time Frame
Baseline and 6 months
Title
Change from Baseline in the number of steps on the Timed Up and Go test at 12 months
Description
in the off-medication condition
Time Frame
Baseline and 12 months
Title
Change from Baseline in the number of steps on the Timed Up and Go test at 6 months
Description
in the off-medication condition
Time Frame
Baseline and 6 months
Title
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
Description
In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Time Frame
Baseline and 6 months
Title
Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months
Description
The scores could range from 0 (no balance confidence) to 100 (good balance confidence).
Time Frame
Baseline and 12 months
Title
Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 6 months
Description
The scores could range from 0 (no balance confidence) to 100 (good balance confidence).
Time Frame
Baseline and 6 months
Title
Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months
Description
The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).
Time Frame
Baseline and 12 months
Title
Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 6 months
Description
The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).
Time Frame
Baseline and 6 months
Title
Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months
Description
The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia).
Time Frame
Baseline and 12 months
Title
Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 6 months
Description
The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia).
Time Frame
Baseline and 6 months
Title
Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months
Description
The scores could range from 0 (no gait impairment) to 64 (severe gait impairment).
Time Frame
Baseline and 12 months
Title
Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 6 months
Description
The scores could range from 0 (no gait impairment) to 64 (severe gait impairment).
Time Frame
Baseline and 6 months
Title
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months
Time Frame
Baseline and 12 months
Title
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months
Time Frame
Baseline and 6 months
Title
Change from Baseline in maximal phonatory time at 12 months
Time Frame
Baseline and 12 months
Title
Change from Baseline in maximal phonatory time at 6 months
Time Frame
Baseline and 6 months
Title
Change from Baseline in dysphonia severity index (DSI) at 12 months
Description
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
Title
Change from Baseline in dysphonia severity index (DSI) at 6 months
Description
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 6 months
Title
Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months
Description
The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment).
Time Frame
Baseline and 12 months
Title
Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months
Description
The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment).
Time Frame
Baseline and 6 months
Title
Adverse events
Time Frame
up to 12 months after surgery
Title
Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months
Description
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
Title
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months
Description
in the off-medication condition
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months
Title
Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months
Title
Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months
Title
Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months
Title
Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months
Title
Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months
Title
Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 12 months
Title
Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months
Description
In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianyou Li, MD, PhD
Phone
+0086-021-64370045
Email
ldy11483@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianyou Li, MD, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianyou Li, MD, PhD
Email
ldy11483@rjh.com.cn

12. IPD Sharing Statement

Learn more about this trial

Asymmetric Targeted DBS for PD With PIGD

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