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Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01345994
Enrollment
Unknown
Registered
2011-05-02
Start date
2009-05-31
Completion date
2013-05-31
Last updated
2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Brief summary

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.

Interventions

PROCEDUREelectro-acupuncture

acupuncture stimulation with electricity

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Martinos Center for Biomedical Imaging
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional MRI brain responseBaseline vs. Post-Acupuncture (average 9 weeks later)Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy

Countries

United States

Contacts

Primary ContactPia Hugus
781-391-7518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026