Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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

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Dystonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Wearable Gait Sensor Analysis

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No