- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00015678
Effects of Flumazenil on Brain Excitability
Effects of Flumazenil on Cortical Excitability in Humans
This study will investigate the effects of the drug flumazenil on brain excitability and the drug's 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 0.5 mg of the drug for about 30 minutes. On the other day, they will receive placebo, administered in the same manner.
Study Overview
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Only healthy volunteers, who are age 21 or older.
No history of surgery with metallic implants or known metallic particles in the brain.
Patients cannot be pregnant (as tested with a pregnancy test).
Patients with a psychiatric illness are not eligible.
No history of seizures.
No cardiovascular disease or drug therapy for chronic depression.
No hypersensitivity to benzodiazepines and related drugs.
No history of drug abuse and/or chronic alcoholism.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Cone AM, Stott SA. Flumazenil. Br J Hosp Med. 1994 Apr 6-19;51(7):346-8.
- Brogden RN, Goa KL. Flumazenil. A preliminary review of its benzodiazepine antagonist properties, intrinsic activity and therapeutic use. Drugs. 1988 Apr;35(4):448-67. doi: 10.2165/00003495-198835040-00004.
- Mohler H, Richards JG. Agonist and antagonist benzodiazepine receptor interaction in vitro. Nature. 1981 Dec 24;294(5843):763-5. doi: 10.1038/294763a0. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 010164
- 01-N-0164
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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