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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT00557076 Completed - Clinical trials for Traumatic Brain Injury

The Efficacy of Familiar Voice Stimulation During Coma Recovery

FAST
Start date: July 2008
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether familiar vocal stimulation, provided during coma recovery, improves outcomes for persons who are unconscious after severe TBI. The primary hypothesis is that unconscious persons who receive standard rehabilitation (SR) plus a high-dose of Familiar Voice stimulation (FVs) compared to unconscious persons who receive SR plus a sham stimulation (Sham Group) will demonstrate: 1. Significantly more neurobehavioral functioning post-intervention compared to pre-intervention. 2. Using Functional Magnetic Resonance Imaging (fMRI), significantly higher average measures of volumetric activity in the whole brain, middle temporal gyrus bilaterally, primary auditory area, bilateral pre-frontal cortex, hippocampus and/or the cerebellum post-intervention compared to pre-intervention.

NCT ID: NCT00554801 Completed - Clinical trials for Traumatic Brain Injury

Central Auditory Processing Disorders Associated With Blast Exposure

Start date: October 2007
Phase: N/A
Study type: Interventional

The incidence of central auditory dysfunction in war fighters who are exposed to high-explosive blasts while serving in combat have not been clearly determined. The objectives of this study are to determine whether central auditory processing (CAP) disorders are associated with exposure to high-explosive blasts. This study will also examine the incidence, magnitude and timing of spontaneous recovery of CAP function from blast exposure. The information provided by this study will help guide clinicians in both the military and VA health care systems regarding the likelihood of central auditory processing disorders in soldiers returning from deployment and suggest some clinical rehabilitative strategies for the treatment of these patients with CAP deficits.

NCT ID: NCT00507104 Completed - Clinical trials for Traumatic Brain Injury

Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)

Start date: September 2006
Phase:
Study type: Observational

This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone [GHRH-arginine-CRH-LHRH] test) after 4 and 12 months.

NCT ID: NCT00505908 Completed - Clinical trials for Traumatic Brain Injury

Non-Interventional F-Two Isoprostane Trial (NIFTI)

NIFTI
Start date: July 2007
Phase:
Study type: Observational

Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored. One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury. Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.

NCT ID: NCT00478400 Completed - Clinical trials for Traumatic Brain Injury

Awareness of Deficit After Combat-related Brain Injury

Start date: October 1, 2007
Phase: N/A
Study type: Observational

This study will use MRI imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury.

NCT ID: NCT00453921 Completed - Brain Injury Clinical Trials

Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)

Start date: February 2007
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million Americans injured each year. Cognitive deficits, particularly in the domains of memory and attention are frequently the source of lingering disability after TBI and a source of enormous distress to the injured individuals and their family/caregivers. To date, interventions to ameliorate chronic cognitive deficits have been directed at either pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and memory/attention training in combination with methylphenidate and (2) use functional MRI (fMRI) to characterize changes in activation of the neural circuitry of memory and attention due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This is a two by two design with medication (methylphenidate/placebo) and cognitive therapy (Memory and Attention Training (MAAT) or an Attention control intervention) as possible interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID), (3) attention control intervention and methylphenidate (0.3 mg/kg BID), or (4) attention control intervention and placebo. Symptom distress, attention and memory performance, and activation patterns of the neural circuitry of attention and memory while undergoing fMRI will be characterized at baseline, and after the four treatment conditions. This study will provide important information on three interventions for the most disabling sequelae of an enormous public health problem. Further, it will help to clarify underlying neural mechanisms and suggest additional treatment possibilities.

NCT ID: NCT00254722 Completed - Clinical trials for Traumatic Brain Injury

Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in Children

Start date: April 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if bone marrow progenitor cell (BMPC) autologous transplantation in children after isolated traumatic brain injury is safe and will improve functional outcome.

NCT ID: NCT00174980 Completed - Clinical trials for Traumatic Brain Injury

Study of Oxycyte in Severe Closed Head Injury

Start date: September 2005
Phase: Phase 2
Study type: Interventional

Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.

NCT ID: NCT00155987 Completed - Brain Injuries Clinical Trials

The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury

Start date: August 2003
Phase: Phase 3
Study type: Interventional

This is a multi-centre randomised trial to evaluate the effect of early decompressive craniectomy on neurological function in patients with severe traumatic brain injury. The primary outcome is neurological function measured at 6 months post injury using the Glasgow Outcome Score. Neurological function is qualified as proportion of favourable outcomes (Glasgow Outcome Score Extended [GOSE] grades 5-8).

NCT ID: NCT00134472 Completed - Clinical trials for Brain Injuries, Traumatic

Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

Start date: December 2002
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.