Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received: March 2, 2010 Last Updated: July 9, 2010 History of Changes

Sponsor:	Charite University, Berlin, Germany
Collaborators:	Max Planck Institute for Human Cognitive and Brain Sciences Institute for Social Medicine, Epidemiology, and Health Economics, Charité
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01079689

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 Control: Placebo Control 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:

MedlinePlus related topics: Acupuncture

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2010
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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, we 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:

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

Exclusion Criteria:

history of neurological and/or psychiatric diseases
history of brain injury
cognitive handicap, severe speech disorder, alcohol or drug abuse
history of neurosurgical intervention
chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
any contraindication for acupuncture (e.g., anti-coagulation therapy)

Additional exclusion criteria for fMRI measurement:
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

Institute for Social Medicine, Epidemiology, and Health Economics, Charité

More Information

No publications provided

Responsible Party:	Institute for Social Medicine, Epidemiology, and Health Economics, Charité ( Claudia M. Witt, MD )
ClinicalTrials.gov Identifier:	NCT01079689 History of Changes
Other Study ID Numbers:	BANS10
Study First Received:	March 2, 2010
Last Updated:	July 9, 2010
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

basic science, healthy volunteers

ClinicalTrials.gov processed this record on September 01, 2010