Effect of Acupuncture on Human Brain Activity - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00200889

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:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Exploring Neurocircuitry of Acupuncture Action With fMRI

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture MRI Scans

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Acupuncture needle will be inserted and stimulated by manual twisting by an acupuncturist.

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.

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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Vitaly Napadow, PhD

Harvard University

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital Dept. of Radiology ( Vitaly Napadow, Ph.D. )
Study ID Numbers:	K01 AT002166-01
Study First Received:	September 13, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00200889 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Acupuncture
Magnetic Resonance Imaging, Functional
Brain Mapping
normal volunteers

ClinicalTrials.gov processed this record on November 22, 2009