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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:
ClinicalTrials.gov Identifier:
NCT01079689
First Posted: March 3, 2010
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Max Planck Institute for Human Cognitive and Brain Sciences
Berlin
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
  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 (Participant)
Primary Purpose: Basic Science
Official Title: Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles

Further study details as provided by Claudia M. Witt, 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 ]
  • Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations [ Time Frame: 1 hour ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01079689     History of Changes
Other Study ID Numbers: BANS10
First Submitted: March 2, 2010
First Posted: March 3, 2010
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
basic science
healthy volunteers