NCT07323602 Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors
| NCT ID | NCT07323602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Dystonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-08-01 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07323602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07323602 currently recruiting?
Yes, NCT07323602 is actively recruiting participants. Contact the research team at ldy11483@rjh.com.cn for enrollment information.
Where is the NCT07323602 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07323602 clinical trial?
NCT07323602 is sponsored by Ruijin Hospital. The trial plans to enroll 50 participants.