Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT01345994
Status:
UNKNOWN
Last Update Posted:
2011-05-02
First Post:
2011-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-29', 'studyFirstSubmitDate': '2011-04-25', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional MRI brain response', 'timeFrame': 'Baseline vs. Post-Acupuncture (average 9 weeks later)', 'description': 'Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female adults aged 20-60.\n2. History\n\n * Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)\n * Nocturnal pain and/or paresthesia in median nerve distribution\n * Symptoms (a and b) greater than 3 months in duration\n3. Physical Exam with two of the following three findings:\n\n * Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)\n * Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)\n4. Nerve conduction findings consistent with mild to severe CTS:\n\nMild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (\\> 3.7milliseconds and/or \\> than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions\n\nModerate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (\\> 4.2 milliseconds).\n\nSevere CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).\n\nExclusion Criteria:\n\n1. Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)\n2. History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.\n3. History of rheumatoid arthritis.\n4. History of wrist fracture with direct trauma to median nerve.\n5. Current usage of prescriptive opioid pain medication.\n6. Severe thenar atrophy.\n7. Nerve entrapment other than median nerve.\n8. Cervical radiculopathy or myelopathy.\n9. Generalized peripheral neuropathy.\n10. A blood dyscrasia or coagulopathy or current use of anticoagulation therapy"}, 'identificationModule': {'nctId': 'NCT01345994', 'briefTitle': 'Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture', 'organization': {'class': 'OTHER', 'fullName': 'Martinos Center for Biomedical Imaging'}, 'orgStudyIdInfo': {'id': 'AT004714'}, 'secondaryIdInfos': [{'id': 'R01AT004714-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AT004714-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture - local', 'description': 'acupuncture on forearm only', 'interventionNames': ['Procedure: electro-acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'acupuncture - distal', 'description': 'acupuncture on both arm and leg', 'interventionNames': ['Procedure: electro-acupuncture']}], 'interventions': [{'name': 'electro-acupuncture', 'type': 'PROCEDURE', 'description': 'acupuncture stimulation with electricity', 'armGroupLabels': ['Acupuncture - local', 'acupuncture - distal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pia Hugus', 'role': 'CONTACT', 'phone': '781-391-7518', 'phoneExt': '306'}, {'name': 'Vitaly Napadow, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Pia Hugus', 'role': 'CONTACT', 'phone': '781-391-7518', 'phoneExt': '306'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martinos Center for Biomedical Imaging', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Vitaly Napadow', 'oldOrganization': 'Massachusetts General Hospital'}}}}