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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05443542 Recruiting - Stroke Clinical Trials

VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI

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

One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. The trial aims to investigate how VR can affect processing speed in the ABI population, and if these effects can transfer into everyday activities. The training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. The training period will last five weeks. Participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. In depth experiences with VR as a training method will be gathered through performing focus group interviews with some of the participants from the VR group, in addition to self-reported questionnaires from all the participants.

NCT ID: NCT05441618 Enrolling by invitation - Trauma, Brain Clinical Trials

Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®

LYOPLACE
Start date: April 2, 2024
Phase:
Study type: Observational

Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.

NCT ID: NCT05440682 Recruiting - Clinical trials for Traumatic Brain Injury

Connectivity in Cranioplasty

Start date: October 27, 2020
Phase: N/A
Study type: Interventional

An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre-, post-cranioplasty and 6 months follow-up assessments.

NCT ID: NCT05427474 Recruiting - Clinical trials for Traumatic Brain Injury

Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury

Start date: December 1, 2022
Phase: Phase 3
Study type: Interventional

Paroxysmal sympathetic hyperactivity (PSH) is a syndrome that comprises a series of signs and symptoms reflecting exacerbated sympathetic activity, including arterial hypertension, fever, tachycardia, generalized perspiration, anomalous motor activity (dystonia, muscle stiffness, extension), tachypnea, mechanical ventilator maladjustment, hypoxemia, hypercapnia, and hyperglycemia. PSH episodes can be intense and prolonged and can occur several times a day and all of these can lead to secondary brain damage and are the main causes of a poor prognosis. Paroxysmal sympathetic hyperactivity also induces a hypermetabolic state with hypercatabolism and inflammation and increases vulnerability to infections, sepsis, and weight loss which in turn are associated with increased morbidity, longer hospital stay, and slower recovery. The marked and sustained increase in catecholamine levels predisposes to the development of cardiomyopathy, lung edema, arrhythmias, and cardiac and multisystemic dysfunction. The reported incidence of paroxysmal sympathetic hyperactivity ranges from 8% to 33% and has no particular age or gender predilection. 80% of these syndrome incidents developed with traumatic brain injury.

NCT ID: NCT05426967 Not yet recruiting - Depressive Symptoms Clinical Trials

rTMS for Military TBI-related Depression

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

The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).

NCT ID: NCT05425251 Recruiting - Clinical trials for Mild Traumatic Brain Injury

BRAINI-2 Elderly Mild TBI European Study

BRAINI2ELDER
Start date: March 1, 2022
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.

NCT ID: NCT05423860 Recruiting - Cancer Clinical Trials

Phase I Human Analytics (HALO) Study

HALO
Start date: March 16, 2022
Phase:
Study type: Observational

Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Specifically, our research study endeavors to improve disease and disorder diagnosis to the earliest clinical states, in preclinical states, and to develop ensemble multivariate biomarker risk scores leading to cardiovascular, oncologic, neurologic, and other diseases and disorders. Additionally, the study aims to: - Evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis. - Evaluate data analysis techniques to improve risk stratification for participants through machine learning algorithms. - Direct participants to relevant and applicable clinical trials.

NCT ID: NCT05419739 Not yet recruiting - Clinical trials for Brain Injuries, Traumatic

Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury

Start date: July 2022
Phase:
Study type: Observational

There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Studies in the literature examining the effect of pupillary response on mortality and outcome in pediatric patients with traumatic brain injury reported that bilaterally dilated pupils were associated with a higher mortality rate. Considering the literature results, we believe that obtaining the GCS-Pupil score by combining GCS and pupillary reaction in pediatric patients with traumatic brain injury will be effective in predicting patient outcomes.

NCT ID: NCT05413733 Recruiting - Clinical trials for Traumatic Brain Injury

Neuropsychological Rehabilitation Over the Internet

IRENE
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Helsinki University Hospital (HUS) has decided on a strategy to provide digital health care services for several medical specialties - a project called the Health Village (HealthVillage.fi). Within Health Village a specific digital My Path program, iRENE Digital Pathway, has been developed for web-based neuropsychological rehabilitation. iRENE Digital Pathway is a structured program for adults with an acquired brain injury (ABI), which utilizes psychoeducative information and self-evaluation questionnaires for attentional, memory and executive disorders with a feedback, and provides training for internal and external memory and other cognitive strategies. The current study will explore if web-based neuropsychological rehabilitation is a feasible and effective method for carrying out rehabilitation for adults with ABI.

NCT ID: NCT05413499 Recruiting - Clinical trials for Traumatic Brain Injury

Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury

BRAINI2
Start date: August 2, 2022
Phase: N/A
Study type: Interventional

Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4). Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms. One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.