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

July 9, 2012 updated by: Claudia M. Witt, Charite University, Berlin, Germany

Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Max Planck Institute for Human Cognitive and Brain Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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. )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.
Time Frame: 26 minutes
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Max Planck Institute for Human Cognitive and Brain Sciences
Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BANS10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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