Transcranial Electrical Stimulation (TCES) / Cerebral Blood Flow (CBF) / Xenon Under Computerized Tomography (Xe/CT) - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00273663

Purpose

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.

Condition	Intervention
Healthy Volunteers	Device: TCES

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	The Effects of Transcranial Electrical Stimulation (TCES) on Cerebral Blood Flow (CBF) With Xenon Under Computerized Tomography (Xe/CT)

Resource links provided by NLM:

MedlinePlus related topics: CT Scans

Drug Information available for: Xenon

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Enrollment:	44
Study Start Date:	January 2006
Study Completion Date:	June 2006

Detailed Description:

Principal Objective : To compare the increase in mean cerebral blood flow in a group of defined zones (the thalamus, anterior cingulate gyrus, the insula, periacqueductal region of the brain stem,the frontal lobes, the striatum and limbic system) in healthy volunteers stimulated or not stimulated by TCES.
Secondary Objective : Description of cerebral blood flow variations in the different zones in order to map electrostimulated areas.
Study design : An experimental, randomized, double-blind, single-centre trial with 2 groups, a study group (stimulated by TCES) and a control group (not stimulated).
Inclusion criteria : 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; participants aged between 18 and 65 having signed a written informed consent ; participants having accepted to be registered on the national eligibility list for subjects participating in a trial without direct individual benefit, and covered by an insurance policy.
Exclusion criteria : Participation in two different study trials without direct individual benefit at the same time. 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 or persons under tutelage.
Study plan: Study group: Xe/CT and transcranial electrostimulation / Control group : Xe/CT
Principal Criterion of Judgement: difference in mean cerebral blood flow between the study group(stimulated) and the control group (not stimulated).
Secondary Criteria of Judgement : Difference in mean cerebral blood flow region per region (thalamus, anterior cingulate gyrus, insula, periacqueductal region of the brain stem, the frontal lobes, the striatum and limbic system).
Number of subjects : 40
Duration of subject participation in study : 2 H 30

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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
18 and 65
informed consent signed

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273663

Locations

France
Service de Neuro-radiologie, hôpital Pellegrin
Bordeaux, France, 33076

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:	Patrice MENEGON, MD	University Hospital, Bordeaux
Study Chair:	Rodolphe THIEBAUT, MD	University Hospital, Bordeaux

More Information

No publications provided

Study ID Numbers:	9376-03, 2003-038
Study First Received:	January 6, 2006
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00273663 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

cerebral blood flow
electrical stimulation
Computed Tomography Scanner, X-Ray
Brain Mapping

Study placed in the following topic categories:

Xenon
Healthy

ClinicalTrials.gov processed this record on September 01, 2009