NCT01079689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

March 2, 2010

Last Update Submit

July 9, 2012

Conditions

Healthy Volunteers

Keywords

basic sciencehealthy volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

needle stimulationOTHER

stimulation with acupuncture needles

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • any contraindication for MRI (e.g., pacemaker, claustrophobia, cochlear implant, metallic implants etc. )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, Leipzig, 04103, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27803655DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 3, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

DE(1)