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NCT Number: NCT07323602

Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors

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.

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Key information

Conditions

Dystonia Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Li

CONTACT

[email protected]

+0086-021-64370045

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Li

CONTACT

[email protected]

+0086-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Beijing Pins Medical Co., Ltd
  • Medtronic
  • Suzhou Sceneray Medical Co. , Ltd

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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