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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01079689
• Date of registration: 02/03/2010
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation BANS
• Scientific title: Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles
• Date of first enrolment: February 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01079689
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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. )



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Other: needle stimulation

Primary Outcome(s)

Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations. [Time Frame: 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]

Secondary ID(s)

BANS10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Max Planck Institute for Human Cognitive and Brain Sciences

Berlin