Effect of Acupuncture on Human Brain Activity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00200889
First received: September 13, 2005
Last updated: December 9, 2013
Last verified: December 2013

September 13, 2005
December 9, 2013
May 2005
December 2013   (final data collection date for primary outcome measure)
Brain activity during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Brain activity; measured via fMRI throughout the study
Complete list of historical versions of study NCT00200889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Acupuncture on Human Brain Activity
Exploring Neurocircuitry of Acupuncture Action With fMRI

This study will determine how acupuncture affects human brain activity.

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy
  • Device: 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.
  • Device: acupuncture
    different forms of acupuncture and sensory stimulation will be used
    Other Name: sensory stimulation
Experimental: acupuncture
different forms of acupuncture will be applied manual acupuncture sensory stimulation electro-acupuncture
Interventions:
  • Device: Manual acupuncture
  • Procedure: Electro-acupuncture
  • Procedure: Sensory stimulation
  • Device: acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Right-handed

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan
  • Any neurological or psychiatric disorders
  • Any pain syndromes
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200889
K01 AT002166-01, K01AT002166-01
No
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital
Massachusetts General Hospital
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Vitaly Napadow, PhD Harvard University
Massachusetts General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP