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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04708613 Recruiting - Clinical trials for Traumatic Brain Injury

University of Pittsburgh Brain Health Initiative

BHI
Start date: November 18, 2019
Phase:
Study type: Observational

This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.

NCT ID: NCT04708561 Completed - Clinical trials for Brain Injuries, Traumatic

Therapy of Pragmatic Disorders in Brain-damaged Individuals

Start date: June 3, 2020
Phase: N/A
Study type: Interventional

This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. We also explore whether the observed progress is maintained one month after the end of treatment and whether it is generalized to neuropsychological tests, video material, and the participants' daily lives. This therapy will be administered to four individuals with brain lesions, for six weeks, at the rate of two weekly sessions of one hour.

NCT ID: NCT04704037 Active, not recruiting - Clinical trials for Mild Traumatic Brain Injury

Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

M4
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.

NCT ID: NCT04688255 Recruiting - Clinical trials for Brain Injuries, Traumatic

Mobile Subthreshold Exercise Program for Concussion--R01

MSTEP-R01
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.

NCT ID: NCT04678115 Active, not recruiting - Stroke Clinical Trials

Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).

NCT ID: NCT04677829 Terminated - Clinical trials for Traumatic Brain Injury

Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)

Start date: March 29, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multi-center, randomized, double-blind, placebo-controlled, multiple-ascending- dose trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of intravenous PNT001 in hospitalized patients with traumatic brain injury.

NCT ID: NCT04666766 Recruiting - Clinical trials for Brain Injuries, Traumatic

Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers

MBI01
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This study will evaluate if traumatic intracranial hemorrhage can be safely ruled out by using a microwave scanner (MD100) in conjunction with a combination of different brain biomarkers analyzed in serum.

NCT ID: NCT04664699 Completed - Clinical trials for Severe Traumatic Brain Injury

Randomized Control Trial to Compare Standard Monitoring and Plethysmographic Variability Index-Guided Fluid Therapy In 64 Severe Traumatic Brain Injury Patients, Aged 18 to 60 Years Old Undergoing Emergency Craniotomies

PVI
Start date: May 29, 2019
Phase: N/A
Study type: Interventional

This randomized control trial aims to assess if Plethysmographic Variability Index (PVI)-based therapy improves patient outcome in terms of reduced amount and type of fluid used, lower postoperative lactate levels, lesser increment in sodium and chloride levels, improvement of blood gases in term of pH and BE, and reduction in serum creatinine as compared to standard monitoring based therapy in patients with severe traumatic brain injury.

NCT ID: NCT04652895 Completed - Anxiety Clinical Trials

Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Start date: December 16, 2020
Phase:
Study type: Observational

The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

NCT ID: NCT04651803 Completed - Clinical trials for Traumatic Brain Injury

Outcome in Traumatic Brain Injury Elderly Patients

Start date: April 2013
Phase:
Study type: Observational

In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years). Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37% of all injury-related death in Europe. This was particularly true for patients ≥ 65 years old and in the most severe case(Glasgow coma score ≤ 8) with mortality rates between 31 to 51%. Over time, epidemiological patterns of TBI are changing. Indeed, in high-income countries, overall incidence is steadily decreasing, but increasing in elderly population with falls becoming the leading cause of TBI. In parallel, the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 (9%) million persons aged ≥65 years in the global population and that this proportion is projected to rise further to 16 % in 2050. Accordingly, we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades. In a study performed in three neuro-intensive care unit (ICUs) from 1997 to 2007, 6-month mortality in patients aged of 70-79 and ≥ 80 years was 59% and 79%, respectively. In severe elderly (≥ 65 years) TBI patients admitted in ICU, hospital and 6-month mortality was 64.6% and 72.9%, respectively. Beyond mortality, TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities, frequent use of oral anticoagulants and/or antiplatelet and/or previous brain disorders. In patients hospitalized in ICU, age (> 59 years) was the strongest parameter associated with an unfavorable outcome including death, vegetative state and severe disability, at 6 month. Moreover, TBI elderly patients (≥ 65 years) had worse functional outcome at discharge than younger patients. Identifying elderly patients who may benefit from ICU remained challenging, since there is no consensual guideline of triage. Traumatic brain-injured patients are particularly concerned by this issue. Nevertheless, few data are available related to outcome in elderly TBI patients requiring ICU.