Health TrialsbyHealthPanel

Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors

ConditionDystonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorRuijin Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of patients clinically diagnosed with isolated dystonia who are candidates for Deep Brain Stimulation (DBS) surgery at Ruijin Hospital. These participants have motor symptoms that are refractory to optimal medical therapy and are scheduled for elective surgical intervention.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Wearable Gait Sensor Analysis

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Correlation between Baseline Gait Features and BFMDRS Improvement

Time frame
Through study completion, up to 6 months

Secondary outcomes

1

Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score

Time frame
Baseline (pre-operative) and 6 months post-operative
2

Change in SF-36 Quality of Life Score

Time frame
Baseline (pre-operative) and 6 months post-operative
3

Gait Characteristics (Spatio-temporal parameters)

Time frame
Baseline (pre-operative)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Suzhou Sceneray Medical Co. , Ltd

Collaborator

Beijing Pins Medical Co., Ltd

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov
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