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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00273663
First received: January 6, 2006
Last updated: June 28, 2007
Last verified: June 2007
  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: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University Hospital, Bordeaux

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00273663     History of Changes
Other Study ID Numbers: 9376-03, 2003-038
Study First Received: January 6, 2006
Last Updated: June 28, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
cerebral blood flow
electrical stimulation
Computed Tomography Scanner, X-Ray
Brain Mapping

ClinicalTrials.gov processed this record on November 25, 2014