Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-28 @ 9:49 PM
Study NCT ID:
NCT05991804
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2023-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International Standards of Neurological Classification for SCI (ISNC-SCI).', 'timeFrame': '30 minutes', 'description': 'This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': '20 minutes', 'description': 'This is a is a clinician-administered scale used to classify spasticity'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': '20 minutes', 'description': 'This is a is a clinician-administered scale used to classify the angles that can be achieved at each joint of the arm'}, {'measure': 'Electromyography (EMG) assessments', 'timeFrame': '90 minutes', 'description': 'This will be assessed by researchers, and classifies the amount of muscle activity occurring during movements of the arms and hands.'}, {'measure': 'Individual goal planning', 'timeFrame': '20 minutes', 'description': 'This is planned between the participant and their therapist, and defines what is important to the participant to gain from their rehabilitation'}, {'measure': 'Spinal Cord Independence Measure (SCIM)', 'timeFrame': '30 minutes', 'description': 'This is a self-assessed outcome which asks the rater about 3 areas of function: self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and mobility'}, {'measure': 'Tetraplegic upper limb activity questionnaire (TUAQ)', 'timeFrame': '30 minutes', 'description': 'This is a self-assessed questionnaire which is a self-assessment of hand and arm function'}, {'measure': 'International SCI data sets quality of life basic data set (SCI-QoL)', 'timeFrame': '15 minutes', 'description': 'This is a self-administered short questionnaire which assesses quality of life'}, {'measure': 'Semi-structured interview', 'timeFrame': '60 minutes', 'description': 'Participants will be asked to speak freely about their experience on this project and any recommendations they have for the team for future studies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Transcutaneous spinal cord stimulation', 'Upper limb'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each year, with around half of these injuries affecting the cervical spine. People who have reduced function and control affecting their upper limbs may have difficulty carrying out activities of daily living (ADLs), significantly affecting their independence. Recovering even partial upper limb function is a top priority among tetraplegics.\n\nRegaining voluntary function in the upper limb can have a huge impact on quality of life. Using TSCS in the upper limb for acute SCI can benefit patients early in their rehabilitation, and may reduce the number of patients with problematic spasticity at discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of improving function and spasticity in this cohort.\n\nThe aim of this feasibility study is to assess and compare the impact of adding TSCS to the standard rehabilitation of inpatients with acute SCI, compared to a sham (placebo) TSCS intervention added to standard rehabilitation, in an effort to enhance upper limb control and function.', 'detailedDescription': "Recruitment:\n\nParticipants will be recruited from the Royal National Orthopaedic Hospital. A member of our research team will contact participants after they have received this information sheet to discuss participation in the study and answer any questions. People who would like to take part in the study will be asked to attend an initial session to see if they are able to tolerate non-invasive SCS.\n\nIntervention:\n\nEligible participants will then be randomised either into the intervention group, where they will receive TSCS or sham TSCS in addition to their regular inpatient rehabilitation. We are using this trial design to assess whether adding TSCS to regular inpatient rehabilitation enhances recovery and voluntary function in this participant cohort, and to test that there is not a placebo effect.\n\nFor both the sham and intervention groups, we will carry out regular assessments. Some of these assessments will be part of standard care as an inpatient at the RNOH, and others will be additional. Please see the outcome measures for further information about these assessments.\n\nFollow-up:\n\nWhen participants have finished their inpatient rehabilitation at the RNOH, we will carry out a semi-structured interview, where we will ask about participants' experience on this study. Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams or Zoom).\n\nParticipants will then be invited to two Follow-up Assessments at the RNOH, where all outcome measures will be repeated. Follow-up 1 will be done once the participant is 6-months post-injury, and Follow-up 2 will be done at 1-year post-injury. If the participant is already 6-months post-injury at discharge, then Follow-up 1 will occur at 1-month post-discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over the age of 18\n2. Recent spinal cord injury (inpatient at the RNOH)\n3. Spinal cord injury level C1-C8\n4. AIS A-D\n5. Willing and able to provide informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant, planning pregnancy or breastfeeding\n2. Those who have a cardiac pacemaker\n3. Active device at stimulating electrode site\n4. Any other musculoskeletal diagnosis affecting the upper limbs\n5. Spinal malignancy\n6. Spinal cord injury due to cancerous growth\n7. Auto-immune disorder\n8. Ongoing infection\n9. Uncontrolled autonomic dysreflexia\n10. Complex regional pain syndrome\n11. Neurological degenerative diseases\n12. Peripheral nerve damage affecting the upper limbs\n13. Taking part in a conflicting research study\n14. People who are unable to tolerate TSCS during their first session'}, 'identificationModule': {'nctId': 'NCT05991804', 'acronym': 'Up-Stim', 'briefTitle': 'Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement', 'orgStudyIdInfo': {'id': '319893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation', 'description': 'Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust', 'interventionNames': ['Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Transcutaneous spinal cord stimulation added to inpatient rehabilitation', 'description': 'Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust', 'interventionNames': ['Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation']}], 'interventions': [{'name': 'Transcutaneous spinal cord stimulation added to inpatient rehabilitation', 'type': 'OTHER', 'description': 'Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs', 'armGroupLabels': ['Transcutaneous spinal cord stimulation added to inpatient rehabilitation']}, {'name': 'Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation', 'type': 'OTHER', 'description': 'Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust', 'armGroupLabels': ['Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA7 4LP', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ufedo Miachi', 'role': 'CONTACT', 'email': 'ufedo.miachi@rnoh.nhs.uk', 'phone': '02089093780'}], 'facility': 'Royal National Orthopaedic Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Joseph Steel, BSc', 'role': 'CONTACT', 'email': 'joseph.steel@nhs.net', 'phone': '02089095500'}, {'name': 'Sarah Massey, PhD', 'role': 'CONTACT', 'email': 'sarah.massey.13@ucl.ac.uk', 'phone': '07713582559'}], 'overallOfficials': [{'name': 'Lynsey Duffell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As the study is only 6 participants IPD will be provided in study publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal National Orthopaedic Hospital NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}