Predicting DBS Outcomes in Dystonia Using Wearable Gait S... | NCT07323602

Studies
Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors

NCT07323602

Sponsor

Ruijin Hospital

Status

Recruiting

Last Update Posted

Jan 7, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Dystonia

Interventions

Wearable Gait Sensor Analysis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Dec 22, 2025

First Submission Date that Met QC Criteria

Dec 22, 2025

First Posted Date

Jan 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2025

Last Update Posted Date

Jan 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LI DIANYOU, Doctor, Ruijin HospitalPrincipal Investigator

Lead Sponsor

Ruijin HospitalOTHER

Collaborators

Name	Class
Suzhou Sceneray Medical Co. , Ltd	INDUSTRY
Beijing Pins Medical Co., Ltd	INDUSTRY
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wearable Gait Sensor Analysis	Device	Patients will wear inertial measurement units (IMUs) on [specify body parts, e.g., lower back, ankles] to record gait data during standardized walking tasks before surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between Baseline Gait Features and BFMDRS Improvement		Through study completion, up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score		Baseline (pre-operative) and 6 months post-operative
Change in SF-36 Quality of Life Score		Baseline (pre-operative) and 6 months post-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically diagnosed with primary or isolated dystonia.
Scheduled to undergo bilateral Deep Brain Stimulation (DBS) surgery.
Able to walk independently or with assistance (sufficient to perform gait analysis).
Willing to participate and sign informed consent.

Exclusion Criteria:

History of other neurological disorders affecting gait (e.g., stroke, severe neuropathy).
Significant orthopedic issues preventing gait assessment.
Cognitive impairment preventing cooperation with study procedures.
Previous functional neurosurgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

The study population consists of patients clinically diagnosed with isolated dystonia who are candidates for Deep Brain Stimulation (DBS) surgery at Ruijin Hospital. These participants have motor symptoms that are refractory to optimal medical therapy and are scheduled for elective surgical intervention.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li	Contact	+0086-021-64370045		ldy11483@rjh.com.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Recruiting	Shanghai			China

Condition Browse Module

MeSH Terms

ID	Term
D004421	Dystonia

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided