Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable Gait Sensor Analysis.
- Who it may be relevant to
- Registry conditions: Dystonia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Correlation between Baseline Gait Features and BFMDRS Improvement [Time frame: Through study completion, up to 6 months]
Secondary outcome measures (3)
- Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score [Time frame: Baseline (pre-operative) and 6 months post-operative]
- Change in SF-36 Quality of Life Score [Time frame: Baseline (pre-operative) and 6 months post-operative]
- Gait Characteristics (Spatio-temporal parameters) [Time frame: Baseline (pre-operative)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07323602 · DYSGAITpredictDBS