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

Healthy Volunteers Clinical Trial

— BANS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079689
• Other study ID #: BANS10
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: July 9, 2012
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• needle stimulation
stimulation with acupuncture needles

Locations

Country	Name	City	State
Germany	Max Planck Institute for Human Cognitive and Brain Sciences	Leipzig

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Berlin, Max Planck Institute for Human Cognitive and Brain Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.		26 minutes	No
Primary	Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations		1 hour	No