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Completed

NCT Number: NCT01079689

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, 04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. )

Treatment and study plan

needle stimulation

Other

stimulation with acupuncture needles

Primary outcomes

  1. Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.

    Time frame: 26 minutes

  2. Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Berlin
  • Max Planck Institute for Human Cognitive and Brain Sciences

Registry information

Official study title

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

Acronym: BANS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 3, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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