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

University Hospital of Bordeaux

Status

Completed

Conditions

Healthy Volunteers

Treatments

Device: TCES

Study type

Interventional

Funder types

Other

Identifiers

NCT00273663

2003-038

9376-03

Details and patient eligibility

About

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.

Full 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

Enrollment

44 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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