Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Martinos Center for Biomedical Imaging.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Martinos Center for Biomedical Imaging
ClinicalTrials.gov Identifier:
NCT01345994
First received: April 25, 2011
Last updated: April 29, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Carpal Tunnel Syndrome
Procedure: electro-acupuncture
Phase 0

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Martinos Center for Biomedical Imaging:

Primary Outcome Measures:
  • Functional MRI brain response [ Time Frame: Baseline vs. Post-Acupuncture (average 9 weeks later) ] [ Designated as safety issue: No ]
    Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy


Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture - local
acupuncture on forearm only
Procedure: electro-acupuncture
acupuncture stimulation with electricity
Experimental: acupuncture - distal
acupuncture on both arm and leg
Procedure: electro-acupuncture
acupuncture stimulation with electricity

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female adults aged 20-60.
  2. History

    • 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)
    • Nocturnal pain and/or paresthesia in median nerve distribution
    • Symptoms (a and b) greater than 3 months in duration
  3. Physical Exam with two of the following three findings:

    • Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
    • Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
  4. Nerve conduction findings consistent with mild to severe CTS:

Mild 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

Moderate 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).

Severe 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).

Exclusion Criteria:

  1. Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
  2. History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
  3. History of rheumatoid arthritis.
  4. History of wrist fracture with direct trauma to median nerve.
  5. Current usage of prescriptive opioid pain medication.
  6. Severe thenar atrophy.
  7. Nerve entrapment other than median nerve.
  8. Cervical radiculopathy or myelopathy.
  9. Generalized peripheral neuropathy.
  10. A blood dyscrasia or coagulopathy or current use of anticoagulation therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345994

Contacts
Contact: Pia Hugus 781-391-7518 ext 306

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Pia Hugus    781-391-7518 ext 306      
Principal Investigator: Vitaly Napadow, PhD         
Sponsors and Collaborators
Martinos Center for Biomedical Imaging
  More Information

No publications provided

Responsible Party: Vitaly Napadow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01345994     History of Changes
Other Study ID Numbers: AT004714, R01AT004714-01
Study First Received: April 25, 2011
Last Updated: April 29, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014