Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors

NCT07323602 | Recruiting DMC

• 1 other identifier: DYSGAITpredictDBS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Keywords

dystonia; deep brain stimulation; wearable Gait Analysis

Outcome Measures

Primary Outcomes (1)

• Correlation between Baseline Gait Features and BFMDRS Improvement

  Through study completion, up to 6 months

Secondary Outcomes (3)

• 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

• Gait Characteristics (Spatio-temporal parameters)

  Baseline (pre-operative)

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Suzhou Sceneray Medical Co. , Ltd: collaborator
• Beijing Pins Medical Co., Ltd: collaborator
• Medtronic: collaborator

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Li

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-11

Locations

CN (1)