Asymmetric Targeted DBS for PD With PIGD

NCT05397340 | Unknown DMC

• 1 other identifier: Asym Stim-PIGD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

postural instability/gait difficulty; deep brain stimulation; subthalamic nucleus; globus pallidus internus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

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

  Baseline and 12 months

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

  Baseline and 6 months

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

  Baseline and 12 months

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

  Baseline and 6 months

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

  Baseline and 6 months

Other Outcomes (14)

• Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

  Baseline and 12 months

• Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

  Baseline and 6 months

• Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

  Baseline and 12 months

Study Arms (2)

L-GPi/R-STN

EXPERIMENTAL

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

Device: Deep brain stimulation

Bi-STN

ACTIVE COMPARATOR

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

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

active DBS with optimal stimulating parameters

Bi-STN; L-GPi/R-STN

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of idiopathic Parkinson's disease
• postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Dianyou Li, MD, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dianyou Li, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 31, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2023

Record last verified: 2022-05

Locations

CN (1)