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.
調査の概要
詳細な説明
研究の種類
入学
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
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学習記録の更新
投稿された最後の更新 (見積もり)
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最終確認日
詳しくは
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