Effects of Flumazenil on Brain Excitability

NCT00015678 | Completed

• 2 other identifiers: 01016401-N-0164
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Healthy

Keywords

Motor Cortex; Drug; GABA; Cortical Modulation; Magnetic Stimulation; Healthy Volunteer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Cone AM, Stott SA. Flumazenil. Br J Hosp Med. 1994 Apr 6-19;51(7):346-8.

  PMID: 8081564 BACKGROUND

• 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.

  PMID: 2839329 BACKGROUND

• 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.

  PMID: 6275273 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 28, 2001
• First Posted: April 30, 2001
• Study Start: April 1, 2001
• Study Completion: April 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-04

Locations

US (1)