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
  Purpose

This study will determine how acupuncture affects human brain activity.


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

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

Resource links provided by NLM:


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 ]

Enrollment: 60
Study Start Date: May 2005
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
different forms of acupuncture will be applied manual acupuncture sensory stimulation electro-acupuncture
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200889

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Vitaly Napadow, PhD Harvard University
  More Information

No publications provided

Responsible Party: Vitaly Napadow, Ph.D., Lic.Ac., Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00200889     History of Changes
Other Study ID Numbers: K01 AT002166-01, K01AT002166-01
Study First Received: September 13, 2005
Last Updated: December 9, 2013
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 July 31, 2014