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Traumatic Brain Injury clinical trials

View clinical trials related to Traumatic Brain Injury.

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NCT ID: NCT06036732 Not yet recruiting - Clinical trials for Traumatic Brain Injury

A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

1. The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. 2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores

NCT ID: NCT05983549 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial

LIMIT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial

NCT ID: NCT05970575 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury

Start date: August 21, 2023
Phase: Phase 2
Study type: Interventional

This study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Traumatic Brain Injury and inflammatory and metabolic parameters.

NCT ID: NCT05897593 Not yet recruiting - Stroke Clinical Trials

Clinical Feasibility & Validation of the Augmented Reality GlenxRose Acquired Brain Injury Rehabilitation Programs

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Factors related to successful rehabilitation in acquired brain injury (ABI) are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Regarding salience, patients may lose interest or find a traditional intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for patients but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Additionally, the same factors that are related to can impact adherence are also related to neuroplasticity. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes for those with ABI. The gamification of rehabilitation therapies using augmented reality (AR) may help promote adherence. Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the experience achieved through AR can further promote salience and be customizable to individual patient requirements. As AR systems are now highly portable, cost-effective, and relatively simple to utilize, they can provide an excellent opportunity to provide more engaging rehabilitation approaches compared to standard care alone. AR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose AR-delivered ABI program (developed by the Cognitive Projections Lab, University of Alberta) has been created in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with ABI rehabilitation therapy. The proposed studies are to investigate the feasibility of implementing this technology alongside routine clinical care, obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose AR ABI-therapies on patient adherence and clinical outcomes, compared to traditional clinical care alone.

NCT ID: NCT05885529 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries

GUEST
Start date: April 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question : • Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury? Participants will do the exams planed in routine care and : - during the expected blood sampling an additional blood sample will be done, - seven days after the discharge a call will be done by the investigator.

NCT ID: NCT05867992 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

MASTER-TBI
Start date: April 1, 2024
Phase:
Study type: Observational

The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are: 1. Which proteins and metabolites are differently expressed in TBI patients' serum? 2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

NCT ID: NCT05826912 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury

APT-TBI-01
Start date: August 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if experimental drug treatment improves recovery after TBI as compared to a control (placebo) group. Changes in recovery will be measured throughout the study. The study drugs listed below are approved by the U.S. Food and Drug Administration (FDA) but are being used "off-label" in this study. This means that the drugs are not currently approved to treat TBI.

NCT ID: NCT05777499 Not yet recruiting - Stroke Clinical Trials

MUSic Therapy In Complex Specialist Neurorehabilitation

MUSICS
Start date: March 2023
Phase: N/A
Study type: Interventional

Aim: Investigate whether patients undergoing specialist rehabilitation after complex neurological injury show different functional outcomes if music therapy is included in their rehabilitation program compared to usual care. Background: Patients with complex needs following a brain, spinal cord, and/or peripheral nerve injury often require a period of specialist neurorehabilitation. This involves multiple therapy disciplines, led by a Consultant in Rehabilitation Medicine, Neurology, or Neuropsychiatry. Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury, it is not routinely commissioned in clinical care due to a lack of supportive evidence. Hypothesis: Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care. Number of participants: 75, aged 16-80 years. Methods: Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy. Both arms receive 1-3 additional therapy sessions per week, matched for duration and number, total 15 hours. After approximately 10-weeks intervention, assessments are repeated. All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit (NRU), with additional qualitative data collection using semi-structured interviews, field notes, staff reports, staff stress surveys, and broader ecological observations. Duration for Participants: From consent to discharge from NRU. Primary Outcome: Change in Functional Independence Measure+Functional Assessment Measure (FIM+FAM), Northwick Park Dependency Scale (NWPDS), and Barthel Activities of Daily Living pre and post 15 hours intervention. Secondary Outcome: Change in quality of life (Flourishing Scale), psychological distress (Hospital Anxiety and Depression Scale, Depression Intensity Scale Circles), social interaction (Sickness Impact Profile Social Interaction Subscale), well-being (WHO Well-Being Index), and communication (Communication Outcomes After Stroke Scale), pre and post 15 hours intervention. Mean difference in well-being (WHO Well-Being Index) throughout the intervention period between music therapy and control therapy groups. Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups.

NCT ID: NCT05671692 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans

Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare pregnenolone and placebo (a placebo is a look-alike substance that contains no active drug) in Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)-Era Veterans with a history of chronic Traumatic Brain Injury (TBI). The main questions it aims to answer are: - Does pregnenolone improve psychological health, overall physical function, cognition, symptoms of PTSD, and pain more than placebo over the 8-week study period, and what is the most effective dose of the drug that is safe and well-tolerated? - What are the biological effects of pregnenolone, and how do pregnenolone and other molecules change over the course of treatment? (and do pregnenolone and other molecules predict clinical improvement?) Participants who are eligible and consent to participate in the study will: - be randomized in a 1:1 ratio to take pregnenolone or placebo - be given pregnenolone or placebo to take each day at home - will participate in 6 visits over 11 weeks for tests, exams and procedures that are for study purposes (each visit will last 1.5 - 3 hours) - be evaluated at each visit to determine if there are any bad reactions to the study drug and if study participation is still appropriate - be financially compensated for their visit time and travel cost

NCT ID: NCT05616910 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Traumatic brain injury (TBI) causes acute deficits in cerebral perfusion which may lead to secondary injury and worse outcomes. Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults. The investigators will perform a randomized controlled trial of iNO treatment in TBI patients acutely after injury. The investigators will then assess perfusion changes with optic neuromonitoring, blood biomarkers, and 6 month clinical outcomes.