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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02980484 Terminated - Clinical trials for Major Depressive Disorder

fMRI-neuronavigated rTMS for the Treatment of Major Depression Associated With TBI

Start date: August 2016
Phase: Phase 2
Study type: Interventional

This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain injury (TBI). Half of patients will receive active treatment, while the other will receive a sham treatment with the option of receiving open-label active treatment afterwards.

NCT ID: NCT02977728 Completed - Clinical trials for Mild Traumatic Brain Injury

Olfactory Function in Patients With Acute Mild Traumatic Brain Injury

Start date: January 2017
Phase:
Study type: Observational [Patient Registry]

In this project the investigators aim to evaluate olfactory and non-olfactory function in patients within the first 24h following a mild traumatic brain injury (acute mTBI) and compare their results to a group of age and sex matched control patients suffering from an orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year after the trauma

NCT ID: NCT02974959 Completed - Clinical trials for Traumatic Brain Injury

Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The purpose of this single-center, prospective, randomized (1:1), double-blind, sham-controlled parallel-arm pilot study is to provide initial evidence of use of the noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and moderate traumatic brain injury to improve clinical recovery. The study compares the safety and effectiveness of an active gammaCore treatment against a sham treatment.

NCT ID: NCT02959294 Withdrawn - Concussion, Brain Clinical Trials

Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries

C-TBI
Start date: November 30, 2018
Phase: Early Phase 1
Study type: Interventional

Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.

NCT ID: NCT02959216 Completed - Clinical trials for Mild Traumatic Brain Injury

Aerobic Exercise for Concussion

Start date: July 23, 2018
Phase: N/A
Study type: Interventional

The use of aerobic exercise treatment in the chronic phase of concussion recovery is well-described in the literature but there are limited existing data on the effect of exercise treatment in the acute phase after sport-related concussion (SRC). This study will compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold aerobic exercise versus those randomized to placebo stretching to evaluate the effect of aerobic exercise in the acute recovery phase.

NCT ID: NCT02957461 Completed - Clinical trials for Brain Injuries, Traumatic

Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes

CASVAL
Start date: February 3, 2017
Phase:
Study type: Observational

This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.

NCT ID: NCT02957331 Completed - Clinical trials for Brain Injuries, Traumatic

Beta Blockade in in Traumatic Brain Injury

Start date: January 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is test the effect of beta-adrenergic blockade on mortality in patients with traumatic brain injury with the hypothesis being that the addition of beta blockade to the treatment regime of this patient population will lower mortality and supress the catecholamine surge that accompanies traumatic brain injury as compared to those who do not receive beta blockade. Half the patients will be randomized to receive propranolol and half will be randomized to receive no beta blocker.

NCT ID: NCT02938130 Recruiting - Cerebral Palsy Clinical Trials

The Impact of Community-based Wellness Programs on The Triple Aim

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

People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.

NCT ID: NCT02931474 Withdrawn - Clinical trials for Traumatic Brain Injury

Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

Start date: October 6, 2016
Phase: Phase 2
Study type: Interventional

Background: People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI. Objective: To see if GHRH can improve sleep in people who have had a TBI. Eligibility: Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who have had a TBI in the past 6 months to 10 years. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube) Interview about their mood and alcohol and drug use Questionnaires about their TBI, mood, and sleep Participants will have 2 overnight study visits a couple weeks apart. These will include: Physical exam Urine sample Two intravenous catheters placed. Blood samples will be taken throughout the night. Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the other. Spending the night in the sleep lab. Their brain waves will be recorded with electrodes placed on the scalp. A questionnaire in the morning about their sleep Participants will be called a few days after each overnight visit. They will be asked about how they are feeling and to rate their sleep.

NCT ID: NCT02924649 Active, not recruiting - Brain Injuries Clinical Trials

Early Mobilisation After Severe Traumatic Brain Injury

Start date: January 2017
Phase: N/A
Study type: Interventional

Increasing focus on the negative effects of bed rest have become more apparent in the intensive care unit within the last decade. A few studies have found an association between early rehabilitation starting at the intensive care unit and outcome after discharge from rehabilitation. The early mobilization presents with challenges regarding haemodynamic stability. The aim of this trial is to assess the feasibility before conducting a larger randomised trial that will investigate benefits and harms of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically feasible in the intensive care unit