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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03998930 Completed - Stroke Clinical Trials

Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients

AWAKE
Start date: March 6, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury. Assumptions : - Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score) - Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness

NCT ID: NCT03998358 Withdrawn - Clinical trials for Traumatic Brain Injury

Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries

Start date: March 19, 2021
Phase:
Study type: Observational

Background: People who have had a traumatic brain injury (TBI) often experience fatigue. Fatigue is the feeling tired all the time. Researchers want to learn more about how TBI and fatigue are related. Objective: To better understand fatigue after TBI in active duty military and veterans. Eligibility: Active duty service members or veterans ages 25-40 who have sustained at least 1 TBI more than 6 months but less than 5 years ago Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests Participants will have Visit 1 the same day as screening. This will include questionnaires and interviews. These will be about their fatigue, quality of life, and health. Participants will wear an activity monitor on their wrist and complete a sleep diary for 7 days at home. Participants will have Visit 2: They will stay in the clinic for 2 nights. The visit will include: - Tests of memory, attention, and thinking - Placement of intravenous (IV) line: A needle will guide a thin plastic tube into the participant s arm vein. - 2 overnight sleeps tests: Participants brain waves will be recorded while they sleep. Small electrodes will be placed on the scalp. Monitors will be placed on the skin. These will measure breathing, heart rate, and movement. Blood will be drawn overnight through the IV line. - Optional hydrocortisone stimulation test: Participants will receive the hormone through the IV line. Blood will be drawn through the IV line 5 times over 1 hour. - Optional MRI: Participants will lie in a machine. This machine is a metal cylinder that takes pictures of the brain.

NCT ID: NCT03995368 Completed - Schizophrenia Clinical Trials

Neuroplasticity in TBI and Schizophrenia

NVEST
Start date: November 9, 2020
Phase: N/A
Study type: Interventional

This proposal will examine measures of neuroplasticity (the brain's ability to alter its function or structure in response to changes in the environment or novel experiences) in Veterans with schizophrenia or traumatic brain injury (TBI). Both conditions are associated with impaired cognition (for example, attention, memory, learning), which is in turn associated with poor community functioning and integration. However, the two disorders differ in their origins: schizophrenia is a neurodevelopmental disorder appearing usually in late adolescence while TBI is an acquired disorder as the result of an injury to the head. Understanding of the root causes of complex cognitive impairments associated with these disorders remains limited. Neuroplasticity is a fundamental brain process that underlies cognitive functioning and may give insight into the causes of cognitive dysfunction in TBI and schizophrenia. Neuroplasticity will be measured using electroencephalography (EEG) by placing small electrodes on the scalp that record the brain's electrical activity. Participants will listen to simple auditory tones and view simple visual patterns while their EEG is recorded. Additionally, participants will have measures of cognition and clinical interviews for diagnosis of a disorder as well as any current levels of symptoms.

NCT ID: NCT03995173 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Pilot rTMS for AUD+mTBI

TMS_AUD+mTBI
Start date: March 21, 2019
Phase: Phase 2
Study type: Interventional

This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.

NCT ID: NCT03992404 Recruiting - Clinical trials for Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

PATTERN
Start date: September 16, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

NCT ID: NCT03990909 Recruiting - Clinical trials for Traumatic Brain Injury

Pilot Study of BCAA on Sleep

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Individuals will be recruited from the VA Portland Health Care System and the community affiliated with Oregon Health & Science University. Traumatic brain injury status will be assessed as a contributing factor. Subjects will be randomized to one of 3 groups (BCAA or one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days. Self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function will be assessed pre and post the experimental period.

NCT ID: NCT03989999 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Transcranial Ultrasonography for the Management of Patients With Mild TBI

TRUST
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is the category of patients eligible for early discharge: 1) patients with mild lesions on the initial CT scan and a GCS 15 after CT scan completion and, 2) patients with no lesion on the initial cerebral CT scan with at least one of the following risk factors: GCS 14 after CT scan completion, persisting post-traumatic nausea/vomiting/headaches, concomitant alcoholic intoxication or patients treated with aspirin. The study will not include mild TBI patients who are not eligible for early discharge: patients with no possibility of home supervision, those with a GCS lower than 14 after the CT scan or those treated with anticoagulant/antiplatelet drugs other than aspirin. The investigators expect the TCD-based strategy to be non-inferior compared to the standard strategy according to French recommendations in terms of the 3-months neurological outcome. From a public health standpoint, the use of TCD as a triage tool may change current guidelines regarding mild TBI management.

NCT ID: NCT03982602 Completed - Clinical trials for Traumatic Brain Injury

Ketogenic Diet for Traumatic Brain Injury

KETI
Start date: July 4, 2019
Phase: Early Phase 1
Study type: Interventional

Traumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.

NCT ID: NCT03976492 Recruiting - Clinical trials for Traumatic Brain Injury

The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury

Start date: December 31, 2020
Phase:
Study type: Observational

Traumatic brain injury (TBI) is the most common type of nerve injury and it severely endangers the public health. It is necessary to accurately measure the early neurological function of brain injury for monitoring its prognosis and therapeutic interventions. Glasgow Coma Score (GCS) and Computed Tomography (CT) are often used to diagnose the severity of TBI. However, GCS has its drawbacks in the observation of prognosis, because it is interfered by analgesics, sedatives and relaxants in the evaluation of neurological function. CT may miss the diagnosis of diffuse axonal injury (DAI) and the monitoring of intracranial pressure (ICP). Secondary injuries after TBI, such as oxidative stress, inflammatory damage, and abnormal metabolism, can destroy cerebral blood vessels and structures, which also affect the diagnosis of injury. Therefore, there is an urgent need for new methods to quickly identify which patients are likely to suffer brain injury or even cause persistent disability. Detection of brain injury biomarkers based on blood and brain tissue has long been used to assess the severity of TBI, but no biomarkers have been found for early diagnosis of mTBI and prognosis of different degrees of brain injury. Protein and metabolic product differences were detected from blood or the lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform, and diagnostic markers of potential traumatic brain injury were found, and their differential and diagnostic values were discussed.

NCT ID: NCT03975023 Completed - Healthy Clinical Trials

Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players

Start date: July 7, 2019
Phase:
Study type: Observational

Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity. The present study aims to assess neurophysiological markers of auditory and visual measures of brain function using the NeuroCatch Platform and eye-tracking technology, respectively. The current gold standard of TBI evaluation, including cognitive and balance assessments, will also be captured.