Clinical Trials for Brain Injury

A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

Ideas for clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning Phase I clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.

Current Trials

Fitness Training After Traumatic Brain Injury (added: 11/16/05).

Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial (added: 11/16/05).

Enteral Glutamine in Neurologically-Injured Patients (added: 11/16/05).

Effect of Hypertonic Resuscitation for Blunt Trauma (added: 11/16/05).

Post-TBI Fatigue and Its Treatment (added: 11/16/05).

Treatment of Post-TBI Depression (added: 11/16/05).

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Study of the Recovery of Mental Functions After Traumatic Brain Injury in Children
UCLA Neuropsychiatric Institute

Purpose: To identify behavioral and brain mechanisms of recovery of mental functioning following Traumatic Brain Injury in children. This study focuses on cognitive functions such as learning, memory and planning that are frequently impaired shortly after a moderate to severe TBI.

Measures: The study involves the participation of parents as well as the child. The child will be studied during two sessions, including behavioral exams, psychiatric exams and brain imaging. The first session will take place within 8 weeks after the TBI and the second session one year after the TBI.

Compensation: Your child will receive up to $325 if he/she completes the study.

If you are interested in this research study, contact our research staff at 310-825-9880.

Added: 10/24/05.

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Pharmacological Intervention in Depression After Traumatic Brain Injury (added: 10/17/05).

Sertraline Vs. Placebo for Symptoms Following Traumatic Brain Injury (added: 10/17/05).

Evaluation of an Intervention Model for Family Crisis and Support (added: 10/17/05).

Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury (added: 10/17/05).

Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury (added: 10/17/05).

Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury (added: 10/17/05).

Problem Sloving for Caregivers of Persons with Brain Injury (added: 10/17/05).

Antidepressant Maintenance In Traumatic Brain Injury (added: 10/17/05).

Age of Blood in Brain Injury (added: 10/17/05).

Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (added: 10/17/05).

Proteomics of Brain Trauma-Associated Elevated Intracranial Pressure (ICP) (added: 10/17/05).

Vietnam Head Injury Study - Phase III (added: 10/17/05).

Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan (added: 10/17/05).

Effects of Perfluorocarbon Oxygen Delivery in Severe Head Injury (added: 10/17/05).

A Trial of Two on-Line Interventions for Child Brain Injury (added: 10/17/05).

Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients (added: 10/17/05).

Intensive Monitoring of Brain Injured Patients (added: 10/17/05).

Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects with Traumatic Brain Injury (added: 10/17/05).

Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State (added: 10/17/05).

Use of Salt-Water Solution to Improve Symptoms in Concussion (added: 10/17/05).

Does Cognitive Rehbilitation Demonstrate Benifits in the Group Setting with People Whom Have Expirienced Brain Injury (added: 10/17/05).

Galantamine in the Treatment of Post-Traumatic Headache (added: 10/17/05).

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TBI and Depression Study: Researchers in the Department of Rehabilitation Medicine at Harborview Medical Center are seeking people with traumatic brain injury (TBI) to participate in a federally funded research study about depression. Major depression may occur more frequently in people with TBI because the injury changes the delicate balance of chemicals in the brain. We hope that early identification and treatment of depression after TBI might improve recovery from and adaptation to this type of injury. If you are interested in this study, please call 206-341-4730 or 1-800-407-8124. (added: 10/07/04)

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The Effect of Community-Based Exercise on Symptoms of Depression in Persons with TBI study is examining the effects of aerobic exercise on depression and anxiety in persons who have had a mild to moderate TBI in the previous 6 months - 5 years. The study offers a supervised 10-week exercise program to participants along with education and motivational components. If you are interested in participating in the study, or for more information, contact Aaron at 206-731-5196. (added: 10/07/04)

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The New York TBI Model System at Mount Sinai School of Medicine in New York City is seeking people who have had a traumatic brain injury and are experiencing depression. The study will evaluate the effectiveness of the drug Zoloft, an anti-depressant, in helping individuals who are depressed after brain injury. To be in this study you must be suffering from depression and be willing to try this medication for a period of 12 weeks. Participants will be randomly assigned, to receive either Zoloft or a sugar pill that contains no medicine. You will be asked to visit Mount Sinai every two weeks to monitor whether changes occur in your level of depression. You will be paid for your time. If interested, please call 866-528-7490 or contact alexis.kramer@mountsinai.org. GCO #02-0677, IRB approved through 09/04.
(added: 9/3/04)

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Idaho State University is recruiting people who have had traumatic brain injuries. A new research project is aimed at understanding more about the needs of these individuals. Officials are interested in anyone with a brain injury, or someone who is a care giver to someone with this type of injury. For more information about this study, you can contact Dr. Beth Hudnall-Stamm at the Institute of Rural Health, or at http://www.isu.edu. (added: 4/27/04)

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Researchers at UT Southwestern Medical Center at Dallas are seeking patients who have suffered a traumatic brain injury with resulting persistent cognitive deficits. The study is designed to evaluate the safety and efficacy of an investigational medication in treating attention or memory impairment from a traumatic brain injury. To be eligible, patients must be 18 to 50 years of age, have experienced a traumatic brain injury at least 12 months ago or longer and must be currently experiencing persistent attention and/or memory deficits. Participants will receive study-related medical evaluations and investigational medication at no cost for the duration of the trial. For more information, call 214-648-7613. (added: 03/23/04)

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Therapy for Reading Problems in Adults After Brain Injury
(added: 11/05/03)

Hypothermia to Treat Severe Brain Injury
(added: 11/01/03)

Prospective Memory in Children with Traumatic Brain Injury
(added: 6/30/03)

Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
(added: 6/30/03)

Measuring Head Impacts in Sports
(added: 5/27/03)

Safety testing of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Laughter & Crying)
(added: 5/26/03)

Progesterone Treatment of Blunt Traumatic Brain Injury
(added: 11/23/02)

The National Acute Brain Injury Study: Hypothermia II (NABISH II)
(added: 7/10/02)

Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
(added: 5/15/02)

Preventing Chronic Whiplash Pain

Physiologic Studies of Spasticity