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Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation (BANS)

This study has been completed.
Sponsor:
Collaborators:
Max Planck Institute for Human Cognitive and Brain Sciences
Berlin
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01079689
First received: March 2, 2010
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to evaluate effects on the brain after complex somatosensory stimulation with acupuncture needle. EEG and fMRI measurements will be performed.


Condition Intervention
Healthy Volunteers
 Other: needle stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations. [ Time Frame: 26 minutes ] [ Designated as safety issue: No ]
  • Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: needle stimulation
    stimulation with acupuncture needles
Detailed Description:

The aim of the study is to evaluate whether the point locations chosen for a complex somatosensory stimulation with acupuncture needles have an essential impact on the change of brain activity in healthy volunteers. For this, the investigators compare three different point locations (one acupuncture point and two non-acupuncture points) stimulated with acupuncture needles. Two measurements each with 20 subjects are planned.

  • With the EEG measurements the impact of the stimulation's location on background rhythm especially in the somatosensoric cortex is evaluated.
  • With the fMRI (functional magnetic resonance imaging) measurements the impact of the stimulation's location on BOLD (Blood Oxygen Level Dependency) signals and on functional connectivity is evaluated.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. healthy subjects of age from 18 to 40 years (inclusive)
  2. right-handed (evaluated by "The Edinburgh Inventory")
  3. with informed consent signed
  4. no acupuncture treatment in the last 12 months
  5. no medical knowledge about acupuncture
  6. free time to take part in the measurements

Exclusion Criteria:

  1. history of neurological and/or psychiatric diseases
  2. history of brain injury
  3. cognitive handicap, severe speech disorder, alcohol or drug abuse
  4. history of neurosurgical intervention
  5. chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
  6. pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy

  7. any contraindication for acupuncture (e.g., anti-coagulation therapy)

    Additional exclusion criteria for fMRI measurement:

  8. any contraindication for MRI (e.g., pacemaker, claustrophobia, cochlear implant, metallic implants etc. )
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079689

Locations
Germany
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Germany, 04103
Sponsors and Collaborators
Charite University, Berlin, Germany
Max Planck Institute for Human Cognitive and Brain Sciences
Berlin
  More Information

No publications provided

Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01079689     History of Changes
Other Study ID Numbers: BANS10
Study First Received: March 2, 2010
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
basic science
healthy volunteers

ClinicalTrials.gov processed this record on May 19, 2013