Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-15 @ 2:45 PM
Study NCT ID:
NCT02914418
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Criteria 1: Number of participants recruited', 'timeFrame': 'Through to study completion, up to 6 months', 'description': 'Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)'}, {'measure': 'Feasibility Criteria 2: Number of participants completing intervention protocol', 'timeFrame': 'Through to study completion, up to 6 months', 'description': '10 participants completing full intervention protocol'}, {'measure': 'Feasibility Criteria 3: Number of Valid data sets', 'timeFrame': 'Through to study completion, up to 6 months', 'description': '10 complete valid data sets'}, {'measure': 'Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants', 'timeFrame': 'Through to study completion, up to 6 months', 'description': 'No serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.'}, {'measure': 'Range of Motion (RoM)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.'}, {'measure': 'Leeds Arm Spasticity Impact Scale (LASIS)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Questionnaire assessing impact of spasticity on a person.'}, {'measure': 'Visual Analogue Scale (Spasticity) (VAS-S)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'A 100mm line with two statements at each end (No spasticity, worst spasticity). The patient will mark on the line their own perception of how bad they feel their spasticity is.'}, {'measure': 'American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.'}, {'measure': 'Spinal Cord Independence Measure (SCIM) - Version 3', 'timeFrame': 'Baseline and 2 weeks', 'description': 'scale developed to address the ability of SCI patients to perform basic activities of daily living independently.'}, {'measure': 'Visual Analogue Scale (Pain) - (VAS-P)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'A 100mm line with two statements at each end (no pain, worst pain). The patient will mark on the line their own perception of how bad they feel their pain is.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transcranial magnetic stimulation', 'Spinal Cord Injuries', 'Muscle Spasticity', 'Pain', 'Spinal Cord', 'Spinal Cord Diseases'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'This study will investigate how repetitive transcranial magnetic stimulation (TMS) using intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of this study will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-70 years old inclusive\n* Traumatic and non-traumatic tetraplegic patient following chronic incomplete (AIS C or D) SCI injury (sustained at least three months ago)\n* Referred to the Sheffield Spinal Injuries Centre\n* Be able to provide written informed consent or verbal consent in the presence of an independent witness\n* Spasticity affecting upper limbs with a Modified Ashworth scale (MAS) 2 or above\n* Stable medical treatment for at least 1 week before and 1 week after TMS application\n* Stable medical condition\n\nExclusion Criteria:\n\n* Aged less than 18 years old\n* Lack the mental capacity to consent\n* Ventilated patients with sedation\n* Very acute (\\<3 months) SCI patients\n* Implanted electrical devices such as pacemakers, Concomitant neurological conditions, including any history of epilepsy\n* Significant joint-related limitation of passive range of movement\n* Unable to attend all TMS sessions\n* Pregnancy\n* Inability to tolerate TBS\n* Significant upper limb contractures'}, 'identificationModule': {'nctId': 'NCT02914418', 'acronym': 'TUSI', 'briefTitle': 'Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Feasibility Study to Investigate the Effects of Transcranial Magnetic Stimulation (TMS) Using Theta Burst Stimulation (TBS) to Treat Upper Limb Dysfunction and Spasticity in Patients With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'STH18997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active iTBS', 'description': 'iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. The hand representation of the primary motor cortex will targeted using a circular coil held over the vertex of skull. Intensity will be set to 80% of Resting Motor Threshold (RMT), which will be determined visually by the lowest percentage of stimulator output which can cause upper limb motor twitch in at least 5 out of 10 attempts.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation using iTBS Paradigm']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham iTBS', 'description': 'Sham iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. Intensity will be set at 80% RMT. Circular coil will be held over vertex of skull but angled away to ensure no neural stimulation.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation using iTBS Paradigm']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation using iTBS Paradigm', 'type': 'DEVICE', 'otherNames': ['repetitive Transcranial Magnetic Stimulation'], 'description': 'TMS is a non-invasive, painless method of stimulating the central and peripheral nervous system. ITBS is a form of TMS which is delivered for \\~200sec and can promote changes in neural activity.', 'armGroupLabels': ['Active iTBS', 'Sham iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yourkshire', 'country': 'United Kingdom', 'facility': 'Princess Royal Spinal Injuries Centre, Northern General Hospital.', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Ram Hariharan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, {'name': 'Ali Gharooni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}