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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04221009 Completed - Clinical trials for Sleep Apnea, Obstructive

Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury

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

Background: Obstructive sleep apnea (OSA) is a sleep disorder that commonly occurs in Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental health, poor physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces the many negative health consequences of the disease. However, adherence to PAP is required to reap the therapeutic benefit. Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is part of the standard of care for OSA treatment with PAP, but on its own is insufficient for improving PAP adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT) which have been shown to increase PAP use and improve PAP adherence in persons without TBI. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel 4-session manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA. Study Aims: Study Aim 1 will test the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 will evaluate the feasibility of outcome and process measures. To date, no treatment exists to ameliorate the adverse consequences of moderate-to-severe TBI. OSA is a treatable health condition that commonly co-occurs with TBI, which is a leading cause of long-term disability. Method: In this study, 19 Veterans will be recruited from inpatient and outpatient TBI and sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe TBI; nonadherent to PAP, able to provide informed consent) will be invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention. Adherence will be measured via objective data from hospital software which monitors PAP use.

NCT ID: NCT04208477 Completed - Clinical trials for Traumatic Brain Injury

"The Effect of Stellate Ganglion Block in Severe Brain Injury"

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

Blood flow through the brain is reduced after brain damage. Secondary brain ischemia caused by hypoxia and hypotension, further increase the susceptibility of the ischemically compromised brain to secondary impairment during this period. In order to determine whether and to what extent blockage of the stellate ganglion (BSG) affects the blood flow to the injured brain, the investigators will measure the variables of brain blood flow before and after BSG using computed tomography angiography (CTA), trans-cranial Doppler ultrasound (TCD), intracranial pressure (ICP) and perfusion computed tomography (PCT) of the brain. At the same time, the investigators would like to evaluate whether and to what extent BSG affects the aseptic inflammatory brain injury response and the biochemical indicators of brain damage in patients with moderate and severe brain injury.

NCT ID: NCT04200976 Completed - Clinical trials for Traumatic Brain Injury

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

Tele-CABA
Start date: September 15, 2019
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction. The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.

NCT ID: NCT04199247 Completed - Clinical trials for Mild Traumatic Brain Injury

Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury

Start date: February 20, 2020
Phase: N/A
Study type: Interventional

The investigators will test the central hypotheses according to the following Specific Aims: Aim 1. Determine if an individually prescribed exercise program initiated within the first week of mild traumatic brain injury can reduce the risk of developing persistent post-concussion symptoms relative to usual care. The investigators hypothesize that the exercise group will have a lower risk of developing persistent post-concussion symptoms than the usual care group. Aim 2. Examine the effect of a two-month exercise program on psycho-social, pain interference, and sleep outcomes following mild traumatic brain injury. The investigators hypothesize the exercise group will report lower anxiety, depression, and pain interference ratings, and higher peer relationship and sleep quality ratings two months of exercise following mild traumatic brain injury compared to usual care.

NCT ID: NCT04192227 Completed - Clinical trials for Traumatic Brain Injury

Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Start date: December 15, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.

NCT ID: NCT04183998 Completed - Clinical trials for Traumatic Brain Injury

Restorative Neuromodulation for Upper Extremity Functions

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

The objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury (TBI) or cervical spinal cord injury (SCI); and to find the physiological changes in the neuromuscular systems after this new intervention with high-resolution electrophysiology and biomedical imaging.

NCT ID: NCT04095377 Completed - Healthy Clinical Trials

Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.

Start date: March 24, 2019
Phase:
Study type: Observational

DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.

NCT ID: NCT04077411 Completed - Clinical trials for Severe Traumatic Brain Injury

Approaches and Decisions for Acute Pediatric TBI Trial

ADAPT
Start date: February 20, 2014
Phase:
Study type: Observational

Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.

NCT ID: NCT04077268 Completed - Clinical trials for Traumatic Brain Injury

Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma

Start date: July 8, 2019
Phase:
Study type: Observational

To study the future of traumatic brain injured patients at day 7 of their trauma Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room. Secondary judgment criteria: - Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP - Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, . - Become TCL patients under AAP or TAC - Number of reconsultation, rehospitalization, new imaging within 7 days after TCL

NCT ID: NCT04074850 Completed - Quality of Life Clinical Trials

The Long-term Consequences After Traumatic Brain Injury in the Elderly

Start date: August 1, 2019
Phase:
Study type: Observational [Patient Registry]

A better understanding of the injury patterns, injury severity, risk profiles, consequences and impact of Traumatic Brain Injury (TBI) in the elderly population is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the long-term consequences of TBI. In order to achieve that goal, injury patterns, injury severity and risk profiles for TBI in the elderly will be mapped. Moreover, a retrospective assessment of brain damage, co-morbidities and post-traumatic history, and a prospective assessment of cognitive functions and quality of life in a 20 years range after TBI will be performed. Finally, a statistical correlation of TBI and different types of neurodegenerative diseases, and an economic costs analysis will be done. All the obtained results will be used to develop a new prognostic tool for the course of the outcomes of TBI in the elderly population.