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Effect of Acupuncture on Human Brain Activity

This study is currently recruiting participants.
Verified July 2011 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00200889
First received: September 13, 2005
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

This study will determine how acupuncture affects human brain activity.


Condition Intervention Phase
Healthy
 Procedure: Manual acupuncture
Procedure: Electro-acupuncture
Procedure: Sensory stimulation
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Exploring Neurocircuitry of Acupuncture Action With fMRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Brain activity during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2005
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Manual acupuncture
    Acupuncture needle will be inserted and stimulated by manual twisting by an acupuncturist.
    Procedure: Electro-acupuncture
    Acupuncture needle will be inserted and electrodes attached to this needle. Electrical current will be passed to stimulate the body via the needle. Current strength will be below pain thresholds.
    Procedure: Sensory stimulation
    A sham stimulation will be produced over the body location. no insertion will be made.
Detailed Description:

Acupuncture is an ancient Chinese practice involving the insertion of needles into specific parts of the body for therapeutic purposes. Although the practice has become more popular in the West, the underlying mechanisms of acupuncture have not been thoroughly examined. This study will determine how acupuncture affects human brain activity, particularly during deqi, a unique sensation experienced during acupuncture that is considered essential to the clinical effectiveness of the practice.

This study will comprise 2 clinic visits. At Visit 1, participants will be randomly assigned to receive manual acupuncture; electro-acupuncture, which passes an electrical current through the needles; or some type of sensory stimulation. At Visit 2, participants will again be randomly assigned to receive one of the three interventions. As participants receive their assigned intervention, they will undergo functional magnetic resonance imaging (fMRI) brain scans. Participants will also have their heart rate monitored during the brain scans.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handed

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan
  • Any neurological or psychiatric disorders
  • Any pain syndromes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200889

Contacts
Contact: Lauren LaCount llacount@nmr.mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lauren LaCount         llacount@nmr.mgh.harvard.edu    
Principal Investigator: Vitaly Napadow, PhD            
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Vitaly Napadow, PhD Harvard University
  More Information

No publications provided

Responsible Party: Vitaly Napadow, Ph.D., Massachusetts General Hospital Dept. of Radiology
ClinicalTrials.gov Identifier: NCT00200889     History of Changes
Other Study ID Numbers: K01 AT002166-01, K01AT002166-01
Study First Received: September 13, 2005
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Acupuncture
Magnetic Resonance Imaging, Functional
Brain Mapping
normal volunteers

ClinicalTrials.gov processed this record on May 21, 2013