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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03885674 Active, not recruiting - Stroke Clinical Trials

Improving Medication Self-Administration and Health After Brain Injury

Start date: July 2016
Phase: N/A
Study type: Interventional

The purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury.

NCT ID: NCT03883451 Completed - Concussion, Mild Clinical Trials

Evaluation of Helmet Technology and Head Impact Exposure

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes grouped by helmet make and model. Secondly, the purpose is to determine the protection of the helmet make and model relative to amount and magnitude of sustained head impacts.

NCT ID: NCT03882554 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03882502 Recruiting - Aphasia Clinical Trials

Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI

NCT ID: NCT03881202 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03881176 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: September 21, 2018
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03874546 Completed - Clinical trials for Traumatic Brain Injury

Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury

PREDICT-TBI
Start date: April 4, 2019
Phase: N/A
Study type: Interventional

Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score. The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.

NCT ID: NCT03874416 Recruiting - Clinical trials for Moderate to Severe Traumatic Brain Injury

Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

REHAB-MDT
Start date: January 25, 2021
Phase: N/A
Study type: Interventional

The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration. As secondary objectives, the study aims to: - demonstrate improvement of specific neuropsychological tests of working memory; - demonstrate improvement of non-specific tasks involving working memory; - assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect; - demonstrate improvement of social integration ability and quality of life; - demonstrate persistence of effects at 3 months and 6 months after the end of treatment; - demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.

NCT ID: NCT03874208 Recruiting - Clinical trials for Traumatic Brain Injury (TBI)

Prediction for Coma Recovery With Comaweb

COMASCORE
Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury.

NCT ID: NCT03868930 Completed - Depression Clinical Trials

Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop

STEP-Home
Start date: June 17, 2019
Phase: N/A
Study type: Interventional

In this proposal, the investigators extend their previous SPiRE feasibility and preliminary effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed to foster reintegration by facilitating meaningful improvement in the functional skills most central to community participation: emotional regulation (ER), problem solving (PS), and attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their collective use and have not been systematically applied to a Veteran population prior to the investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily function, reduce anger and irritability, and assist reintegration to civilian life through return to work, family, and community, while simultaneously providing psychoeducation to promote future engagement in VA care. The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans; (b) nonstigmatizing (not "therapy" but a "skills workshop" to boost acceptance, adherence and retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is not required for enrollment); (d) integrative (focus on the whole person rather than specific and often stigmatizing mental and physical health conditions); (e) comprised of Veteran-specific content to teach participants cognitive behavioral skills needed for successful reintegration (which led to greater acceptability in feasibility study); (f) targets anger and irritability, particularly during interactions with civilians; (g) emphasizes psychoeducation (including other available treatment options for common mental health conditions); and (h) challenges beliefs/barriers to mental health care to increase openness to future treatment and greater mental health treatment utilization. Many Veterans who participated in the development phases of this workshop have gone on to trauma or other focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home. The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of mental health, cognitive, and emotional function simultaneously and bolsters reintegration in a short-term group to maximize cost-effectiveness while maintaining quality of care.