Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

NCT01345994 | Unknown Early Phase 1 DMC

• 2 other identifiers: AT004714R01AT004714-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Functional MRI brain response

  Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy

  Baseline vs. Post-Acupuncture (average 9 weeks later)

Study Arms (2)

Acupuncture - local

EXPERIMENTAL

acupuncture on forearm only

Procedure: electro-acupuncture

acupuncture - distal

EXPERIMENTAL

acupuncture on both arm and leg

Procedure: electro-acupuncture

Interventions

electro-acupuncture PROCEDURE

acupuncture stimulation with electricity

Acupuncture - local; acupuncture - distal

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults aged 20-60.
• 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
• 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)
• 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).

You may not qualify if:

• Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
• History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
• History of rheumatoid arthritis.
• History of wrist fracture with direct trauma to median nerve.
• Current usage of prescriptive opioid pain medication.
• Severe thenar atrophy.
• Nerve entrapment other than median nerve.
• Cervical radiculopathy or myelopathy.
• Generalized peripheral neuropathy.
• A blood dyscrasia or coagulopathy or current use of anticoagulation therapy

Sponsors & Collaborators

• Martinos Center for Biomedical Imaging: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Pia Hugus

CONTACT

781-391-7518

Study Design

• Study Type: interventional
• Phase: early phase 1
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: May 2, 2011
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 2, 2011

Record last verified: 2011-03

Locations

US (1)