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

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01079689
• Lead Sponsor: Charite University, Berlin, Germany

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.	26 minutes
Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations	1 hour

Trial Locations

Locations (1)

Max Planck Institute for Human Cognitive and Brain Sciences; 🇩🇪 Leipzig, Germany