Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-07 @ 4:24 AM
Study NCT ID:
NCT07074392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Murley Score (CMS)', 'timeFrame': '6 months post operative', 'description': 'Shoulder function will be assessed using the Constant-Murley Score (CMS), a validated composite measure of shoulder function. The CMS ranges from 0 to 100 points, where higher scores indicate better shoulder function. The score incorporates four components: pain (15 points), activities of daily living (20 points), range of motion (40 points), and strength (25 points). A score of 100 represents full, pain-free shoulder function with normal strength and range of motion, while a score of 0 reflects complete dysfunction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Nerve Injury', 'Neck Dissection']}, 'referencesModule': {'references': [{'pmid': '37600003', 'type': 'RESULT', 'citation': 'Costello MC, Errante EL, Smartz T, Ray WZ, Levi AD, Burks SS. Clinical applications of electrical stimulation for peripheral nerve injury: a systematic review. Front Neurosci. 2023 Aug 3;17:1162851. doi: 10.3389/fnins.2023.1162851. eCollection 2023.'}, {'pmid': '27956321', 'type': 'RESULT', 'citation': "Gane EM, Michaleff ZA, Cottrell MA, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. Prevalence, incidence, and risk factors for shoulder and neck dysfunction after neck dissection: A systematic review. Eur J Surg Oncol. 2017 Jul;43(7):1199-1218. doi: 10.1016/j.ejso.2016.10.026. Epub 2016 Nov 17."}]}, 'descriptionModule': {'briefSummary': "Shoulder weakness and pain are common after neck dissection surgery for head and neck cancer. This is often caused by injury to the spinal accessory nerve, which controls important shoulder muscles. Recovery can be slow and incomplete, affecting patients' ability to return to daily activities. This project will test whether a brief, low-dose electrical stimulation treatment can help the nerve heal faster and improve shoulder function. The treatment is applied during surgery and is safe, non-invasive, and quick to deliver. If successful, this approach could lead to better rehabilitation, less disability, and improved quality of life for patients undergoing cancer surgery. The project also supports the development of new medical technology and offers a pathway to expand the use of electrical stimulation in other nerve injuries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing neck dissection\n\nExclusion Criteria:\n\n* Previous neck dissection, previous implantable stimulator (i.e. pacemaker), previous spinal accessory nerve injury, pre-existing shoulder injury or weakness'}, 'identificationModule': {'nctId': 'NCT07074392', 'acronym': 'SpARES', 'briefTitle': 'Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Assessing the Feasibility and Effect of Post-operative Electrical Stimulation on Spinal Accessory Nerve Recovery After Neck Dissection for Head and Neck Cancer', 'orgStudyIdInfo': {'id': '19054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care'}, {'type': 'EXPERIMENTAL', 'label': 'Electrical stimulation', 'description': 'Post-operative electrical stimulation of spinal accessory nerve post neck dissection.', 'interventionNames': ['Device: Electrical Stimulation']}], 'interventions': [{'name': 'Electrical Stimulation', 'type': 'DEVICE', 'description': 'Custom stimulator will deliver a 1hour stimulation protocol post-operatively at 20 Hz, with biphasic pulses (100 µs duration, 0-2mA amplitude range).', 'armGroupLabels': ['Electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'email': 'dunne4@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '34969'}], 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Demographics Patient outcomes (CMS scores, electromyography and patient reported outcomes)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}