- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273663
Transcranial Electrical Stimulation (TCES) / Cerebral Blood Flow (CBF) / Xenon Under Computerized Tomography (Xe/CT)
June 28, 2007 updated by: University Hospital, Bordeaux
The Effects of Transcranial Electrical Stimulation (TCES) on Cerebral Blood Flow (CBF) With Xenon Under Computerized Tomography (Xe/CT)
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France, 33076
- Service de Neuro-radiologie, hôpital Pellegrin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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difference in mean cerebral blood flow between the study group(TCES stimulated) and the control group (TCES not stimulated).
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Secondary Outcome Measures
Outcome Measure |
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrice MENEGON, MD, University Hospital, Bordeaux
- Study Chair: Rodolphe THIEBAUT, MD, University Hospital, Bordeaux
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
January 6, 2006
First Submitted That Met QC Criteria
January 6, 2006
First Posted (Estimate)
January 9, 2006
Study Record Updates
Last Update Posted (Estimate)
June 29, 2007
Last Update Submitted That Met QC Criteria
June 28, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 9376-03
- 2003-038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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