Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07323602

Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors

Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Ruijin Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

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

Interventions

TypeNameDescription
DEVICEWearable Gait Sensor AnalysisPatients 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.

Timeline

Start date
2025-08-01
Primary completion
2029-12-01
Completion
2029-12-01
First posted
2026-01-07
Last updated
2026-01-07

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07323602. Inclusion in this directory is not an endorsement.