NCT00273663

Brief Summary

Direct stimulation of the cerebral cortex induces an increase in cerebral blood flow. Although this information is known, it has never been documented during Transcranial Cerebral Electrical Stimulation (TCES), which is a non invasive technique. It is used to modulate the opiate endogenous system, mainly in opioid users but no cerebral blood flow mapping of the anatomic regions involved in this modulation of the opiate system under electrical stimulation has been performed in functional Computerized Tomography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 29, 2007

Status Verified

June 1, 2007

First QC Date

January 6, 2006

Last Update Submit

June 28, 2007

Conditions

Healthy Volunteers

Keywords

cerebral blood flowelectrical stimulationComputed Tomography Scanner, X-RayBrain Mapping

Outcome Measures

Primary Outcomes (1)

  • difference in mean cerebral blood flow between the study group(TCES stimulated) and the control group (TCES not stimulated).

Secondary Outcomes (1)

  • Difference in mean cerebral blood flow zone per zone (thalamus, anterior cingulate gyrus, insula, periacqueductal region of the brain stem, the frontal lobes, the striatum and limbic system).

Interventions

TCESDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants free of any known neurological or psychiatric disorder
  • participants not under treatment particularly with opioids, analgesics or medication containing codeine or morphine for at least a month
  • and 65
  • informed consent signed

You may not qualify if:

  • Contraindications to Computerized Tomography
  • Subjects diagnosed clinically with a Neurological or Psychiatric disorder
  • Subjects who have been under analgesics or morphine agonists for less than a month
  • Pregnant or breastfeeding mothers and women without an adequate contraception
  • Drug addicts
  • persons under tutelage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neuro-radiologie, hôpital Pellegrin

Bordeaux, 33076, France

Location

Related Publications (1)

  • Gense de Beaufort D, Sesay M, Stinus L, Thiebaut R, Auriacombe M, Dousset V. Cerebral blood flow modulation by transcutaneous cranial electrical stimulation with Limoge's current. J Neuroradiol. 2012 Jul;39(3):167-75. doi: 10.1016/j.neurad.2011.06.001. Epub 2011 Aug 10.

    PMID: 21835468DERIVED

Study Officials

  • Patrice MENEGON, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Rodolphe THIEBAUT, MD

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

January 1, 2006

Study Completion

June 1, 2006

Last Updated

June 29, 2007

Record last verified: 2007-06

Locations

FR(1)