Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015678
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-04-28
Brief Title:
Effects of Flumazenil on Brain Excitability
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Flumazenil on Cortical Excitability in Humans
Status:
COMPLETED
Status Verified Date:
2002-04
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:
This study will investigate the effects of the drug flumazenil on brain excitability and the drugs relationship to a natural brain chemical called GABA Flumazenil is commonly used in hospitals to reverse the effects of a group of drugs called benzodiazepines one of which is Valium Benzodiazepines act by enhancing the effects of GABA
Healthy volunteers 21 years of age and older may be eligible for this study Candidates will be screened with a medical history and physical and neurological examinations
Participants will have transcranial magnetic stimulation TMS four times on two different days before and after receiving an intravenous through a vein infusion of either flumazenil or placebo an inactive sugar solution as follows
TMS study 1
Drug or placebo infusion
TMS study 2 - 15 minutes after infusion
TMS study 3 - 60 minutes after infusion
TMS study 4 - 120 minutes after infusion
In transcranial magnetic stimulation a very brief electrical current is passed through an insulated coil wire placed on the scalp These currents stimulate the cortex outer part of the brain They may cause muscle hand or arm twitching if the coil is near the part of the brain that controls movement or they may affect other reflexes or movements During the study subjects may be asked to make movements do simple tasks or tense muscles To record the electrical activity of muscles electrodes will be taped to the skin over the muscles tested In some cases the studies will be videotaped
Flumazenil will be infused through a catheter thin plastic tube attached to a needle placed in an arm vein On one day subjects will receive a 1-mg injection of flumazenil followed by a continuous infusion of 05 mg of the drug for about 30 minutes On the other day they will receive placebo administered in the same manner
Healthy volunteers 21 years of age and older may be eligible for this study Candidates will be screened with a medical history and physical and neurological examinations
Participants will have transcranial magnetic stimulation TMS four times on two different days before and after receiving an intravenous through a vein infusion of either flumazenil or placebo an inactive sugar solution as follows
TMS study 1
Drug or placebo infusion
TMS study 2 - 15 minutes after infusion
TMS study 3 - 60 minutes after infusion
TMS study 4 - 120 minutes after infusion
In transcranial magnetic stimulation a very brief electrical current is passed through an insulated coil wire placed on the scalp These currents stimulate the cortex outer part of the brain They may cause muscle hand or arm twitching if the coil is near the part of the brain that controls movement or they may affect other reflexes or movements During the study subjects may be asked to make movements do simple tasks or tense muscles To record the electrical activity of muscles electrodes will be taped to the skin over the muscles tested In some cases the studies will be videotaped
Flumazenil will be infused through a catheter thin plastic tube attached to a needle placed in an arm vein On one day subjects will receive a 1-mg injection of flumazenil followed by a continuous infusion of 05 mg of the drug for about 30 minutes On the other day they will receive placebo administered in the same manner
Detailed Description:
The purpose of this study is to investigate the effects of flumazenil on cortical excitability in healthy human volunteers Flumazenil acts as a potent benzodiazepine BZP-specific antagonist by competing at the central synaptic gamma-aminobutyric acid GABA receptor site However the relationship between GABA and flumazenil without BZPs is not well known We plan to determine if intravenous IV administration in therapeutic dosage alters cortical excitability as measured by transcranial magnetic stimulation TMS The long-term plan is to identify a pharmacological method to reduce cortical inhibition that might be useful in stroke rehabilitation
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 |
|---|---|---|---|
| 01-N-0164 | None | None | None |