Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Wearable sensors to predict DBS results for people with dystonia

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

Run by Ruijin Hospital · NCT07323602 · Data updated 2026-11-12

This study will test whether wearable sensors that record walking patterns before surgery can predict how well deep brain stimulation will work for people with dystonia.

More Dystonia trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment50 (estimated)
SponsorRuijin Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedDecember 2029
Study endsDecember 2029
Registry record updatedJanuary 7, 2026
Trial IDNCT07323602 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with primary or isolated dystonia who are scheduled for bilateral DBS, can walk sufficiently for gait testing, and can provide informed consent.

Probably not a fit

Patients with other neurological disorders affecting gait, major orthopedic limitations, severe cognitive impairment, or prior functional neurosurgery are unlikely to benefit from this prediction approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants scheduled for bilateral deep brain stimulation will undergo preoperative gait analysis using wearable sensors to capture spatiotemporal and kinematic features of walking. Clinical outcomes will be measured with the Burke‑Fahn‑Marsden Dystonia Rating Scale and the SF‑36 before surgery and at postoperative follow-ups to quantify motor change and quality of life. Researchers will compare preoperative gait biomarkers with postoperative clinical response to identify patterns associated with better DBS outcomes. The observational design does not change clinical care but aims to develop predictive markers for future patient selection.

Why it matters

Potential benefit: If successful, this approach could help clinicians predict which patients are most likely to benefit from DBS and tailor treatment planning.

How similar studies have gone: Sensor-based gait biomarkers have shown promise in Parkinson's disease and other movement disorders, but using preoperative wearable gait features to predict DBS outcomes in dystonia is relatively novel and less established.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.