Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:37 AM
Study NCT ID:
NCT07425756
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
taVNS Combined With TENS on Motor Function in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer assessment of upper extremity (FMA-UE)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The FMA-UE was used to assess motor impairment. It includes 33 items assessing movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand joints of the paretic arm. Each item consists of a 3-point scale (0, 1, and 2), with a total maximum score of 66.'}, {'measure': 'Chinese version of brief memory and executive test (BMET)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The Chinese version of BMET will be used to assess cognitive function. It incorporates tests divided into two main categories: i) executive functioning and processing speed; and ii) orientation and memory. The initial performance of each item is converted to item score (0-2) and the total score (0-16) was used for statistical analysis, where a higher score indicates better general cognitive function.'}], 'secondaryOutcomes': [{'measure': 'Jacket test', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The jacket test will be used to assess the upper limb proficiency in putting on and removing a long-sleeved jacket. The participants will be required to put on a long-sleeved coat completely, so that it was straight on their shoulders, and then to remove it completely, while maintaining a standing position. The time taken to complete the task was recorded.'}, {'measure': 'Motor Activity Log (MAL)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The motor activity log (MAL) will be used to assess the ADLs. The MAL has 30 items including object manipulation and upper limb gross activities. Each item is in both quality of movement and amount of movement on a 6-point Likert scale (0-5). The total scale ranges from 0 to 150 with higher score indicate better ADL.'}, {'measure': 'Capabilities of upper extremity test (CUE-T)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The CUE-T will be used to assess the upper limb function capacity. It consists of 19 unilateral and bilateral upper limb tasks. Depending on the item, scoring is based on performance of the task, the number of repetitions of the task, or time to complete the task. Raw scores are converted to a 5-point scale (0-4). Total score ranges from 0 to 120 with higher score indicate greater functional capacity. Affected side or unaffected side scores can be obtained by adding the score of the unilateral items on each side'}, {'measure': 'Hand grip strength', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The K-Grip hand-hold dynamometer (K-Grip, kinvent biomecanique, Montpellier, France) will be used for hand grip measurement. The participants will be seated in a comfortable chair with arm support and elbow in 90° flexion. Participants will be asked to make a maximal effort for at least 5 s with verbal encouragement. There were three trials for both side and the average value will be used for statistical analysis.'}, {'measure': 'Pinch grip strength', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The electronic Jamar pinch gauge will be used to measure the later pinch grip strength. The participants will be seated in a comfortable chair with arm support and elbow in 90° flexion. Participants will be asked to make a maximal effort for at least 5 s with verbal encouragement. There will be three trials for both side and the average value will be used for statistical analysis.'}, {'measure': 'Capabilities of upper extremity-questionnaire (CUE-Q)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The CUE-Q will be used to assess the self-prospective functional limitation. It consists of 32 for unilateral and bilateral upper limb use, addressing areas of reaching and lifting, pulling, and pushing, wrist actions, and hand and finger actions. The responses are given on a 5-point Likert scale representing self-perceived difficulty in performing the action. Total score ranges from 0 to 160 with higher score indicate lesser functional limitation.'}, {'measure': 'Stroke impact scale (SIS)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': 'The SIS will be used to assess the quality of life. The SIS comprises 59 items covers eight domains of quality of life and an extra question on stroke recovery. Each item is rated on a 5-point Likert scale in terms of the difficulty in completing each item. The summative scores are generated for each domain, ranging from 0 to 100.'}, {'measure': 'Community integration measure(CIM)', 'timeFrame': 'Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).', 'description': "The Chinese version of CIM will be used to assess individuals' perceptions of community integration. It is a 10-item questionnaire with each item rated on a 5-point Likert scale, yielding a total score that ranges from 10 to 50. Higher scores indicate a better degree of perceived community integration."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Liu, Ng, and Ng (2014) Translation and initial validation of the Chinese (Cantonese) version of community integration measure for use in patients with chronic stroke. Biomed Res Int 2014(1):623836.'}, {'type': 'BACKGROUND', 'citation': 'Vellone, Savini, Fida, Dickson, Melkus, Carod-Artal, Rocco, and Alvaro (2015) Psychometric evaluation of the Stroke Impact Scale 3.0. J Cardiovasc Nurs 30(3):229-241.'}, {'type': 'BACKGROUND', 'citation': 'Oleson and Marino (2014) Responsiveness and concurrent validity of the revised capabilities of upper extremity-questionnaire (CUE-Q) in patients with acute tetraplegia. Spinal Cord 52(8):625-628.'}, {'type': 'BACKGROUND', 'citation': 'Marino, Kern, Leiby, Schmidt-Read, and Mulcahey (2015) Reliability and validity of the capabilities of upper extremity test (CUE-T) in subjects with chronic spinal cord injury. J Spinal Cord Med 38(4):498-504.'}, {'type': 'BACKGROUND', 'citation': 'Uswatte, Taub, Morris, Light, and Thompson (2006) The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology 67(7):1189-1194.'}, {'type': 'BACKGROUND', 'citation': 'Chen, Lai, Chung, and Ng (2017) The Jacket Test for assessing people with chronic stroke. Disabil Rehabil 39(25):2577-2583.'}, {'type': 'BACKGROUND', 'citation': 'Wolf, Catlin, Ellis, Archer, Morgan, and Piacentino (2001) Assessing Wolf Motor Function Test as Outcome Measure for Research in Patients After Stroke. Stroke 32(7):1635-1639'}, {'type': 'BACKGROUND', 'citation': 'Ren, Wong, Lai, and Ng (2025) Psychometric assessment of the translated and culturally adapted Chinese (Cantonese) of the brief memory and executive test in people with stroke. Eur J Phys Rehabil Med 61(3):401-410. https://doi.org/10.23736/S1973-9087.25.08873-2'}, {'type': 'BACKGROUND', 'citation': 'Fugl-Meyer, Jaasko, Leyman, Olsson, and Steglind (1975) The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med 7(1):13-31.'}]}, 'descriptionModule': {'briefSummary': 'the current study is a Blinded Randomised Controlled Trial investing the effectiveness of Combining Transcutaneous Vagus Nerve Stimulation with Peripheral Nerve Stimulation on Upper Limb Motor Function in People with Stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. aged 55 - 75 years old;\n2. diagnosed with stroke confirmed by magnetic resonance imaging or computed tomography for more than 6 months;\n3. had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;\n4. had at least 5 degrees of wrist extension in the antigravity position;\n5. be able to communicate\n\nExclusion Criteria:\n\n1. had neurological disease other than stroke, e.g., Parkinson's disease or dementia;\n2. ongoing healthy condition, e.g., angina pectoris, pain, or arthritis;\n3. had any contraindications of taVNS (metal implants in the brain, history of seizure)"}, 'identificationModule': {'nctId': 'NCT07425756', 'briefTitle': 'taVNS Combined With TENS on Motor Function in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effect of Combining Transcutaneous Vagus Nerve Stimulation With Peripheral Nerve Stimulation on Upper Limb Motor Function in People With Stroke: A Single- Blinded Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '25-VNS-GRF-LJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'taVNS + TENS', 'description': 'participate will received taVNS cominged with TENS', 'interventionNames': ['Device: transcutaneous auricular vagus nerve stimulation', 'Device: transcutaneous electrical nerve stimulation', 'Other: task-oriented training']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham-taVNS + TENS', 'description': 'participate will received sham-taVNS cominged with TENS', 'interventionNames': ['Device: sham transcutaneous auricular vagus nerve stimulation', 'Device: transcutaneous electrical nerve stimulation', 'Other: task-oriented training']}, {'type': 'SHAM_COMPARATOR', 'label': 'taVNS + sham-TENS', 'description': 'participate will received taVNS cominged with sham-TENS', 'interventionNames': ['Device: transcutaneous auricular vagus nerve stimulation', 'Device: sham transcutaneous electrical nerve stimulation', 'Other: task-oriented training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control training group', 'description': 'participate will receive exercise training only', 'interventionNames': ['Other: task-oriented training']}], 'interventions': [{'name': 'transcutaneous auricular vagus nerve stimulation', 'type': 'DEVICE', 'description': 'The left cymba conchae was selected as taVNS stimulation side. The taVNS was delivered by earphone-shaped stimulators for 30 minutes with the stimulation parameters as follows: 0.3-ms square pulses at 20 Hz for 30 seconds with a duty cycle of 1:1; and the intensity of the stimulation was individually adjusted according to the tolerance of participants', 'armGroupLabels': ['taVNS + TENS', 'taVNS + sham-TENS']}, {'name': 'sham transcutaneous auricular vagus nerve stimulation', 'type': 'DEVICE', 'description': 'The sham stimulation will be delivered with a shame model of the same device that used in the taVNS intervention. The interference of the device will display that the device is working normally while no electrical current output.', 'armGroupLabels': ['sham-taVNS + TENS']}, {'name': 'transcutaneous electrical nerve stimulation', 'type': 'DEVICE', 'description': 'TENS will be delivered with commercial TENS machine. The stimulation parameters were as follows: continuous 0.2-ms square pulses at 100 Hz with the intensity adjusted according to the tolerance of each patient. Disposable surface electrodes of 5X5 cm2 were applied to stimulate the median nerve and the superficial radial nerve of both the affected and non-affected upper limbs. The placebo stimulation was delivered with a device that looked identical but had its internal electrical circuit disconnected.', 'armGroupLabels': ['sham-taVNS + TENS', 'taVNS + TENS']}, {'name': 'sham transcutaneous electrical nerve stimulation', 'type': 'DEVICE', 'description': 'The sham stimulation will be administered using a device that looks identical to the TENS device used in the TENS intervention. However, the internal electrical circuit of this device will be disconnected.', 'armGroupLabels': ['taVNS + sham-TENS']}, {'name': 'task-oriented training', 'type': 'OTHER', 'description': 'A physiotherapist supervised the intervention and monitored individual progress. The task-oriented training aims to improve the motor recovery of the upper limbs through the systematic and repetitive movement of shoulder, elbow, forearm, wrist and fingers. The task-oriented training will be conducted in seating position with a table in front. Each training task will be repeated for 10 repetitions per set with 1 minute of rest between sets.The progressions are repositioning from gravity eliminate to against position, improve movement quality, increasing number of sets and shortening rest period.', 'armGroupLabels': ['control training group', 'sham-taVNS + TENS', 'taVNS + TENS', 'taVNS + sham-TENS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shamay Ng, PhD', 'role': 'CONTACT', 'email': 'shamay.ng@polyu.edu.hk', 'phone': '+852 2766 4889'}, {'name': 'Shamay Ng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Shamay NG, PhD', 'role': 'CONTACT', 'email': 'shamay.ng@polyu.edu.hk', 'phone': '+852 27664889'}], 'overallOfficials': [{'name': 'Shamay Ng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be requested based on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}