Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:49 AM
Study NCT ID:
NCT07323602
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004421', 'term': 'Dystonia'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between Baseline Gait Features and BFMDRS Improvement', 'timeFrame': 'Through study completion, up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score', 'timeFrame': 'Baseline (pre-operative) and 6 months post-operative'}, {'measure': 'Change in SF-36 Quality of Life Score', 'timeFrame': 'Baseline (pre-operative) and 6 months post-operative'}, {'measure': 'Gait Characteristics (Spatio-temporal parameters)', 'timeFrame': 'Baseline (pre-operative)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dystonia', 'deep brain stimulation', 'wearable Gait Analysis'], 'conditions': ['Dystonia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed with primary or isolated dystonia.\n* Scheduled to undergo bilateral Deep Brain Stimulation (DBS) surgery.\n* Able to walk independently or with assistance (sufficient to perform gait analysis).\n* Willing to participate and sign informed consent.\n\nExclusion Criteria:\n\n* History of other neurological disorders affecting gait (e.g., stroke, severe neuropathy).\n* Significant orthopedic issues preventing gait assessment.\n* Cognitive impairment preventing cooperation with study procedures.\n* Previous functional neurosurgery.'}, 'identificationModule': {'nctId': 'NCT07323602', 'briefTitle': 'Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'DYSGAITpredictDBS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Wearable Gait Sensor Analysis', 'type': 'DEVICE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li', 'role': 'CONTACT', 'email': 'ldy11483@rjh.com.cn', 'phone': '+0086-021-64370045'}], 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Li', 'role': 'CONTACT', 'email': 'ldy11483@rjh.com.cn', 'phone': '+0086-021-64370045'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Suzhou Sceneray Medical Co. , Ltd', 'class': 'INDUSTRY'}, {'name': 'Beijing Pins Medical Co., Ltd', 'class': 'INDUSTRY'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'LI DIANYOU', 'investigatorAffiliation': 'Ruijin Hospital'}}}}