Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273663
Status:
COMPLETED
Last Update Posted:
2007-06-29
First Post:
2006-01-06
Brief Title:
Transcranial Electrical Stimulation TCES Cerebral Blood Flow CBF Xenon Under Computerized Tomography XeCT
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
The Effects of Transcranial Electrical Stimulation TCES on Cerebral Blood Flow CBF With Xenon Under Computerized Tomography XeCT
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 stemthe 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 XeCT and transcranial electrostimulation Control group XeCT
Principal Criterion of Judgement difference in mean cerebral blood flow between the study groupstimulated 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
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 XeCT and transcranial electrostimulation Control group XeCT
Principal Criterion of Judgement difference in mean cerebral blood flow between the study groupstimulated 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2003-038 | None | None | None |