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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04549532 Active, not recruiting - Concussion, Mild Clinical Trials

Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI)

T-MD
Start date: June 15, 2021
Phase: N/A
Study type: Interventional

Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.

NCT ID: NCT04548596 Recruiting - Clinical trials for Traumatic Brain Injury

NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients

NOVEL ICP
Start date: September 10, 2014
Phase:
Study type: Observational

This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), and Duke University Medical Center. In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length. Multimodality high-resolution physiological signals will be collected from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices. In particular, the collected data will be used to support: Development and validation of noninvasive intracranial pressure (nICP) algorithms. Development and validation of continuous monitoring of neurovascular coupling state for brain injury patients Development and validation of noninvasive approaches of detecting elevated ICP state. Development and validation of approaches to determine most likely causes of ICP elevation. Development and validation of approaches to detect acute cerebral hemodynamic response to various neurovascular procedures.

NCT ID: NCT04548180 Completed - Clinical trials for Traumatic Brain Injury

Genome-Wide Assocation Study in Patients With Brain Injury Associated Fatigue and Altered Cognition (BIAFAC)

Start date: June 21, 2021
Phase:
Study type: Observational

The aim of this study is elucidate genetic susceptibility of patients with traumatic brain injury (TBI) and symptoms of Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) using genome-wide association study (GWAS).

NCT ID: NCT04543162 Recruiting - Clinical trials for Traumatic Brain Injury

Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)

Biotraumap
Start date: October 2, 2019
Phase:
Study type: Observational

The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal. The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI. The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.

NCT ID: NCT04540783 Recruiting - Clinical trials for Traumatic Brain Injury

The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training in Patients With TBI

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

Long-term sequelae in TBI is a well-recognized burn. We designed a proof of concept study, randomized, double-blind, placebo-controlled to evaluate 36 adult TBI patients. To evaluate the early and late effects of 10 days of 20 minutes applying transcranial direct-current stimulation (tDCS) in the dorsolateral prefrontal cortex (DLPFC), bilateral temporal cortex (CTB) and compare to sham stimulation, and online cognitive training. We expect that the active group will differ from the sham group, showing larger effect sizes in the cognitive assessment.

NCT ID: NCT04540445 Recruiting - Clinical trials for Brain Injuries, Traumatic

Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children

Start date: March 11, 2020
Phase:
Study type: Observational

The purpose of this study is to gather information and compare the potential use of pupillometry to identify concussions and post concussive syndrome with standard age appropriate assessments. The study will compare concussed pediatric patients 5-17 years of age recruited from the emergency department within 72 hours following injury with age and gender matched non-concussed pediatric patients recruited from primary care clinics. Assessment of both concussed and non-concussed subjects will take place at the initial enrollment visit and will be repeated at 1-2 weeks for the concussed subjects and at 12-14 weeks for both groups.

NCT ID: NCT04539509 Withdrawn - Clinical trials for Mild Traumatic Brain Injury

Post-Concussion Aerobic Exercise

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.

NCT ID: NCT04530955 Recruiting - Clinical trials for Traumatic Brain Injury

Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.

NCT ID: NCT04530032 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury

Start date: December 7, 2020
Phase: N/A
Study type: Interventional

Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative diseases. Despite extensive research there are no pharmacological therapies which have demonstrated significant improvement in neurological or cognitive recovery. Changes in glucose metabolism are considered the hallmark metabolic response to TBI and ketosis has been proposed as a therapy to ameliorate metabolic dysfunction. This trial investigates the therapeutic potential of a ketogenic or modified Atkins diet on neurocognitive outcome following moderate-severe TBI.

NCT ID: NCT04527289 Completed - Trauma, Brain Clinical Trials

Impact of Amantadine on Traumatic Brain Injury

Start date: September 30, 2020
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate whether the addition of amantadine to the management regimen of traumatic brain injury patients would have a favorable effect on recovery and neurological complications in association with prognosis biomarkers Interleukin-18 (IL-18), Neuron-specific enolase (NSE) and (Neurotensin).