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

NCT ID: NCT01079689

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Keywords

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basic science healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Interventions

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needle stimulation

stimulation with acupuncture needles

Intervention Type OTHER

Eligibility Criteria

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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)

8. any contraindication for MRI (e.g., pacemaker, claustrophobia, cochlear implant, metallic implants etc. )
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Max Planck Institute for Human Cognitive and Brain Sciences

OTHER

Sponsor Role collaborator

Berlin

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, Leipzig, Germany

Site Status

Countries

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Germany

References

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Long X, Huang W, Napadow V, Liang F, Pleger B, Villringer A, Witt CM, Nierhaus T, Pach D. Sustained Effects of Acupuncture Stimulation Investigated with Centrality Mapping Analysis. Front Hum Neurosci. 2016 Oct 18;10:510. doi: 10.3389/fnhum.2016.00510. eCollection 2016.

Reference Type DERIVED
PMID: 27803655 (View on PubMed)

Other Identifiers

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BANS10

Identifier Type: -

Identifier Source: org_study_id