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Brain Concussion clinical trials

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NCT ID: NCT04938570 Recruiting - Concussion, Brain Clinical Trials

Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment

Start date: June 1, 2021
Phase:
Study type: Observational

The investigators aim to use a repeated measures observational study utilising a battery of multimodal assessment tools (symptom, cognitive, visual, motor). The investigators aim to recruit 200 rugby players (male and female) from University Rugby Union teams and local amateur rugby clubs in the North East of England. The multimodal battery assessment used in this study will compare metrics between digital methods and against traditional assessment.

NCT ID: NCT04932278 Recruiting - Concussion, Brain Clinical Trials

The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

Start date: September 22, 2021
Phase: N/A
Study type: Interventional

This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.

NCT ID: NCT04925453 Recruiting - Clinical trials for Mild Cognitive Impairment

tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

Start date: January 19, 2021
Phase: N/A
Study type: Interventional

The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.

NCT ID: NCT04890925 Recruiting - Clinical trials for Mild Traumatic Brain Injury

A Community Support Network Intervention in SOAR Project Intimate Partner Violence-Related Traumatic Brain Injury

SOAR-CSNI
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Intimate Partner Violence (IPV) comprises physical, sexual and emotional abuse and controlling behaviors imposed by an intimate partner. It is estimated that up to 92% of women who survive IPV may have suffered one or more traumatic brain injuries (TBI) from blows to the head, face, and neck, and/or anoxia or hypoxia due to strangulation. Even mild TBI may manifest as alternations in consciousness, black out, dizziness, disorientation, anxiety, depression, post-traumatic stress disorder, muscles weakness or paralysis and deficits in memory, attention, planning as well as executive functions. These signs and symptoms of TBI and their consequences impact the quality of life of women surviving IPV. Furthermore, survivors experiencing multiple IPV may acquire larger extent of the injury. Though this is recognized as an urgent and serious issue worldwide, it has been remarkably understudied. To improve the quality of life of women experiencing IPV-related TBI, and to prevent potential longer-term consequences, an evidence-based therapeutic treatment is an urgent need. The Supporting Survivors of Abuse and Brain Injury through Research (SOAR) Project at the University of British Columbia-Okanagan was designed to integrate TBI knowledge into community-based supports. This Michael Smith Foundation for Health Research (MSFHR) trainee application will focus on the evaluation of the effectiveness of a community support network intervention for women with IPV-related TBI. The outcomes will generate valuable evidence to inform potential new TBI-informed policies regarding community-based and health care supports for survivors of IPV.

NCT ID: NCT04885205 Completed - Concussion, Mild Clinical Trials

Use of CBT-I in Individuals With a Concussion

Start date: April 30, 2021
Phase: N/A
Study type: Interventional

Sleep disturbances have been shown to contribute to poorer recovery from a concussion. Furthermore, sleep disturbances have been associated with more frequent and severe post-concussion symptoms including headache, vertigo, anxiety, depression, and decreased short term memory reducing quality of life and productivity at work or school. Additionally, recent research indicates that individuals with a concussion who have poor sleep quality have increased levels of Neurofilament light (NfL) and tau biomarkers indicating that there may still be axonal damage after weeks or months after the initial concussion injury. Post-concussion symptoms have been associated with higher levels of these biomarkers and there has been a report of higher levels of NfL and tau years following a concussion event. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia yet it remains unclear if this treatment method is effective in improving sleep outcomes, reducing concomitant post-concussion symptoms, and biomarkers of neural injury/risk in individuals post- concussion. The central hypothesis for this project is treating sleep disturbances will yield a clinically relevant reduction in concomitant post-concussion symptoms. The objective for the proposed study is to determine if CBT-I will reduce insomnia symptoms and improve concomitant post-concussion symptoms in individuals after concussion and if symptom improvements are maintained at 6-weeks and 12-weeks after CBT-I intervention.

NCT ID: NCT04874389 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Multidimensional Classification of Mild Traumatic Brain Injury (mTBI)

Start date: May 2021
Phase:
Study type: Observational

This study aims to explore possible solutions needed for valid and reliable multidimensional objective assessment tools to use in screening performers for concussions, as well as, for use postinjury assessment and management of the mild traumatic brain injury, regardless of time since injury occurrence. These mobile tools would also enable clinicians to test the effectiveness of the interventions used post-concussion, prior to fully releasing the performer back into full performance/active status.

NCT ID: NCT04869059 Recruiting - Clinical trials for Traumatic Brain Injury

Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation

HDtDCS-TBI
Start date: August 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in military veteran participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

NCT ID: NCT04867317 Not yet recruiting - Clinical trials for Mild Traumatic Brain Injury

Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

GRIT
Start date: July 15, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

NCT ID: NCT04861688 Completed - Clinical trials for Traumatic Brain Injury

NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury

SAMURAI
Start date: August 23, 2021
Phase: Phase 3
Study type: Interventional

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.

NCT ID: NCT04856241 Recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Making Football Safer for Women: Implementing an Injury Prevention Program

Prep-to-Play
Start date: April 22, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to determine how we can best support coaches to implement an injury prevention (IP) program (Prep-to-Play) in female community Australian Football. We will recruit at least 140 female community football teams from 15 different football leagues in Victoria, Australia. Teams will be competing in U16, U17, U18, U19 or open womens competitions. We will train and support coaches to implement the IP program and evaluate the effects of the IP program on injuries across two football seasons.