|
Effects of Flumazenil on Brain Excitability Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Effects of Flumazenil on Brain Excitability conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Effects of Flumazenil on Brain Excitability Clinical research trials and Effects of Flumazenil on Brain Excitability medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Effects of Flumazenil on Brain Excitability. Effects of Flumazenil on Brain Excitability Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Effects of Flumazenil on Brain Excitability clinical trial. Test subjects typically obtain the finest healthcare available for their Effects of Flumazenil on Brain Excitability condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Effects of Flumazenil on Brain Excitability  Effects of Flumazenil on Brain Excitability
Effects of Flumazenil on Brain Excitability
For Condition: Stroke,Healthy
Status: Completed
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 7
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010164; 01-N-0164
Study Start Date: April 26, 2001
Record last reviewed: April 10, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015678
Other Stroke Studies:
1. Effect of Hydrocortisone on the Brain
2. Perimenopause-Related Mood and Behavioral Disorders
3. Treatment of Non-Tuberculous Mycobacterial Infections with Interferon Gamma
4. Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study
5. Electrophysiology and Blood Flow in Patients with Schizophrenia and Their Siblings
Related Studies:
Other Stroke Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Effects of Flumazenil on Brain Excitability
|
|
|
|
|
|
|
|
