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

Tracking Information
First Received Date ^ICMJE	March 2, 2010
Last Updated Date	March 24, 2011
Start Date ^ICMJE	February 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01079689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation
Official Title ^ICMJE	Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers
Intervention ^ICMJE	Other: needle stimulation stimulation with acupuncture needles
Study Arms
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	April 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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. )
Gender	Both
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01079689
Other Study ID Numbers ^ICMJE	BANS10
Has Data Monitoring Committee	No
Responsible Party	Claudia M. Witt, MD, Institute for Social Medicine, Epidemiology, and Health Economics, Charité
Study Sponsor ^ICMJE	Charite University, Berlin, Germany
Collaborators ^ICMJE	Max Planck Institute for Human Cognitive and Brain Sciences Institute for Social Medicine, Epidemiology, and Health Economics, Charité
Investigators ^ICMJE
Information Provided By	Charite University, Berlin, Germany
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP