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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05916417 Recruiting - Clinical trials for Traumatic Brain Injury

TMS-fNIRS Personalized Dosing

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS. Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)

NCT ID: NCT05913505 Recruiting - Clinical trials for Traumatic Brain Injury

Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Start date: February 15, 2023
Phase: Early Phase 1
Study type: Interventional

Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).

NCT ID: NCT05906056 Recruiting - Stroke Clinical Trials

Continuous Passive Motion Versus Heterotopic Ossification

CPMversusHO
Start date: May 12, 2023
Phase: N/A
Study type: Interventional

The investigators hypothesize that Heterotopic Ossification (HO) formation can be suppressed if the application of a Continuous Passive Motion (CPM) device can be performed for a substantial amount of time. The investigators will use the following study design: a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. The comparison between the treatment and referent groups of the outcomes will prove the prophylactic power of CPM against HO.

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: NCT05889650 Not yet recruiting - Clinical trials for Intracranial Hypertension

External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

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

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift <5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.

NCT ID: NCT05889117 Recruiting - Clinical trials for Traumatic Brain Injury

Brain Stimulation for Concussion

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a new type of magnetic brain stimulation in patients with persistent post-concussive symptoms. Participants will undergo detailed MRI scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the study aims to answer are: - Will this new type of treatment result in fewer symptoms and better daily functioning? - What are the effects of this treatment on brain functioning?

NCT ID: NCT05886400 Recruiting - Clinical trials for Mild Traumatic Brain Injury

The Effects of Environmental Distractions on SCAT6 Outcomes

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

The purpose of this study is to assess the effects of visual and auditory distractions on SCAT5 scores. The study is designed to identify the effects of about 80 participants completing the SCAT5 in college-aged athletes. All participants will perform the same tasks in two settings (distracted and non-distracted). The central hypothesis is that there will be a significant association between distractions and a lower score on the SCAT5. The cognitive screening, neurological screen, and mBESS should showcase a decrease scores during the distracted environment.

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: NCT05862571 Recruiting - Brain Concussion Clinical Trials

Screening Instruments for Measuring Visual Symptoms in Victims of Concussion

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

Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Furthermore, it is unknown whether optometric measurements currently used in assessing vision problems are consistent with patients' subjective complaints experienced in everyday life. A better understanding of patients' visual challenges combined with objective measurements, will contribute to a better and more efficient diagnostic investigation and treatment. The aim of this study is to get a better understanding of patients who are suffering from visual dysfunction after mTBI. This understanding will be gained by: 1. developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI. 2. developing eye tracking based screening tools applicable both in- and outside of optometry clinics 3. examining relationships between self-reported data, eye tracking measurements and optometric measurements. The study will consist of N = 200 subjects. N = 100 of the subjects are suffering from mTBI (commotio group). The second group N = 100 is the non-injured group that preferably will consist of relatives to the subjects in the commotio group. The subjects in both groups have to answer the questionnaires regarding subjective visual complains, undergo optometric tests and undergo eye tracking measurements.