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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05533060 Recruiting - Clinical trials for Traumatic Brain Injury

Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

Clinical evaluation is crucial in the clinical diagnosis, treatment, and prognosis prediction in patients with traumatic brain injury (TBI). However, the existing evaluation systems are not perfect, because many factors are not taken into account, for example, there is a lack of molecular diagnostic criteria for evaluating patients with TBI. We attempt to collect the patient's clinical data and combine it with neuroimaging, as well as molecular biomarkers generated by single-cell sequencing to assess their neurological status and outcome. The clinical and molecular data collection and analysis will be helpful to evaluate the patient's neurological condition and predict the patient's outcome more accurately.

NCT ID: NCT05531383 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury

Start date: November 26, 2021
Phase: N/A
Study type: Interventional

Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury

NCT ID: NCT05527041 Enrolling by invitation - Clinical trials for Mild Traumatic Brain Injury

A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings

Start date: July 1, 2023
Phase:
Study type: Observational

The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings. The EBLens will be based on a concussion diagnostic algorithm from the FDA cleared EyeBOX device, developed by Oculogica, and eye-tracking data collected from a wearable set of eye-tracking glasses, developed by Adhawk Microsystems. Once the EBLens is prototyped, an algorithm for diagnosing concussion will be developed that is specifically appropriate for the EBLens via a case-control clinical study comparing 100 concussed to 100 non-concussed subjects (Phase I). Participants, age 18-35 years, will be recruited from the KACH research team and affiliated providers and clinical sites. Concussed individuals will be assessed within 72 hours of concussion. Demographics, basic medical history, symptom severity, a visio-vestibular exam and the EBLens scan will be collected on both injured cases and uninjured controls at a single time point. The algorithm and the EBLens will be validated in a subsequent, prospective cohort validation study (Phase II) designed for FDA submission. The correlation of the EBLens output with resolution of symptoms will also be observed in longitudinal follow-up of concussed participants in the validation study. The participant population for this study will be cadets recruited from the USMA and young athletes recruited from affiliated sites during baseline concussion testing. Participants will be assessed at baseline at the start of their academic year or sports season. Those participants who experience a concussive injury will be assessed again at three time points; 1) within 72 hours of injury, 2) weekly until and at the time of initiation of a graded return to activity protocol, and 3) upon clearance for unrestricted RTP/RTD.

NCT ID: NCT05524402 Active, not recruiting - Anxiety Clinical Trials

Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).

NCT ID: NCT05521815 Completed - Clinical trials for Traumatic Brain Injury With Loss of Consciousness

Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury

Start date: August 23, 2022
Phase: N/A
Study type: Interventional

PURPOSE: The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients. BACKGROUND: Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year. The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).

NCT ID: NCT05520710 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Symptom-Targeted Rehabilitation for Concussion

STAR-C2
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a mild traumatic brain injury (mTBI). The two methods are 1) providing educational materials (Education Group) and 2) individual cognitive rehabilitation delivered by a trained Occupational Therapist or Speech-Language Pathologist (Therapy Group). The study is a pilot randomized controlled clinical trial (RCT), and will serve as pilot data for a future RCT.

NCT ID: NCT05517954 Recruiting - Epilepsy Clinical Trials

Cortical Excitability in Post-traumatic Epilepsy

Start date: August 1, 2022
Phase:
Study type: Observational

To test whether measures of cortical excitability derived from motor cortex transcranial magnetic stimulation (TMS) in patients with traumatic brain injury reflect heightened excitability relative to healthy controls and whether such measures can be used to distinguish patients with post-traumatic epilepsy from patients with head trauma but no epilepsy

NCT ID: NCT05515640 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Dysautonomia and Systemic Interactions in Traumatic Brain Injury

DYSI-TBI
Start date: August 1, 2019
Phase:
Study type: Observational

Following brain injury, complex interactions between the nervous system and other organs are frequently encountered. Systemic effects may be induced by dysregulation of the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. This observational study will investigate the link between clinical, physiological and biochemical expressions of dysautonomic reactions and physiological stress, and their relations to sympathetic activation in traumatic brain injury patients treated in the neurointensive care unit.

NCT ID: NCT05503316 Recruiting - Stroke Clinical Trials

The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

Persons with an injury of the central nervous system clearly experience motor impairments. Among the most commonly described consequences are gait abnormalities and impaired balance. Although these are undeniably linked, they are also influenced by other factors. A recent systematic review (Xie, 2022) reports impaired balance, the presence of depression or anxiety, and decreased function of the lower limbs as important risk factors for fear of falling in persons after a stroke. Also for people with a spinal cord injury, the fear of falling has a major impact on their level of participation and quality of life (Sing, 2021). Preventing falls and reducing fear of falling is an important part of neurological rehabilitation programs as it is known that fear of falling has a negative impact on the patient's activity level. This in turn will lead to an increased risk of falling and a negative effect on neurological recovery due to insufficiently practicing their balance while walking. Since 2019 the rehabilitation center of UZ gent offers GRAIL training. This device aims to train walking balance and gait adaptability in a virtual environment. Patients who are admitted and/or undergoing ambulatory rehabilitation at UZ Gent are given the opportunity to complete a 5-week training schedule on the GRAIL. Before and after this training intervention period, the investigators evaluate the gait pattern of these patients. After the training period, the patients also complete a questionnaire about their experience while training on the GRAIL and often also indicate that they become more confident in their own balance when walking. That is why the researchers now also want to measure this. Research questions: 1. Do people with high confidence in their balance when walking differ from those with low confidence in their balance when walking? 2. Does GRAIL training have a different effect on confidence in balance than traditional rehabilitation? To answer the 2nd research question, patients who follow the traditional rehabilitation (control group) also receive the same tests as the people who follow GRAIL training. Randomization (prepared in advance via a computer program) determines who will follow the GRAIL training and who will follow the traditional rehabilitation.

NCT ID: NCT05499806 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Cohort Study on the Effects of Aging in Acquired Brain Injury Patients

BRAINReADAPT
Start date: March 18, 2022
Phase:
Study type: Observational [Patient Registry]

A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.