Wearable sensors to predict DBS results for people with dystonia
Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07323602 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Li
- Email: ldy11483@rjh.com.cn
- Phone: +0086-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.