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Concussion, Mild clinical trials

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NCT ID: NCT06212726 Not yet recruiting - Concussion, Mild Clinical Trials

RTL Concussion Communication

Start date: August 28, 2024
Phase: N/A
Study type: Interventional

This study is aimed at improving health outcomes for adolescents who sustain sport and recreation related concussions (SRRC) by enhancing Return to Learn (RTL). The study will conduct a quasi-experimental school-based 2 phase study involving 200 students with SRRC. The first phase will be descriptive to evaluate current standards (n=50). Phase 2 will compare students whod receive either standard of care RTL (n=75) or RTL augmented by a communication tool (RTC+; n=75).

NCT ID: NCT06147596 Not yet recruiting - Concussion, Mild Clinical Trials

Heading in Football: Impact on Neural Blood Biomarkers

HEADLINE
Start date: June 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to evaluate the safety of heading in football. We will study the release of biomarkers in blood that reflect microscopic neural damage. The main questions this study aims to answer are: - Does participation in a football match lead to a change in biomarkers that reflect microscopic neural damage? - Is the dose of exposure during a football match related to the magnitude of change in biomarkers that reflect microscopic neural damage? Participants will participate in a regular football match and provide blood samples before and right after the football match. The football match will be recorded on video to count the number of headers of all participants.

NCT ID: NCT05943561 Not yet recruiting - Concussion, Mild Clinical Trials

Biomarkers in Concussion

Start date: September 2023
Phase:
Study type: Observational

This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.

NCT ID: NCT05847608 Not yet recruiting - Concussion, Mild Clinical Trials

Omega-3 Treatment for Concussion in Adolescents

CONCUSS
Start date: June 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test omega-3 fatty acid supplementation as a treatment in adolescents with a concussion. The main questions it aims to answer are: - Does supplementing with omega-3 fatty acids improve time to recovery following sport related concussion. - Does supplementing with omega-3 fatty acids improve health related quality of life following concussion. - Does supplementing with omega-3 fatty acids change post-concussion symptoms following concussion. - Does supplementing with omega-3 fatty acids change saliva concentrations of interleukin-6 following concussion. - Does supplementing with omega-3 fatty acids change saliva concentrations of cortisol following concussion. Participants will be randomized to receive either an omega-3 supplement or placebo after they have been diagnosed with a concussion. Researchers will compare the omega-3 supplement group and placebo group to see if omega-3 fatty acids, consumed as a treatment, can improve time to recovery, health related quality of life and symptom burden, and whether omega-3 fatty acids alter interleukin-6 and cortisol concentrations in saliva following a concussion.

NCT ID: NCT05660356 Not yet recruiting - Clinical trials for Growth Hormone Deficiency

Growth Hormone Deficiency in Mild Traumatic Brain Injury

Start date: February 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this randomized control trial is to test if growth hormone therapy is a safe and effective treatment for patients suffering from growth hormone deficiency and persistent post-concussion symptoms. The main questions it aims to answer are: 1. Is growth hormone therapy effective at mitigating persisting post-concussion symptoms in patients with growth hormone deficiency? 2. Is it feasible to conduct a larger trial to examine efficacy of growth hormone therapy in patients with persistent post-concussion symptoms and growth hormone deficiency? Participants will be asked to complete an initial assessment for study inclusion and to complete clinical outcome questionnaires. If a participant meets study criteria they will be randomized to receive either growth hormone therapy (provided by Pfizer) or a placebo (provided by Pfizer). Participants will be instructed on how to self-administer their assigned drug daily for three months. Monthly follow-up visits will include a blood draw to measure a biomarker and clinical outcome questionnaires. At the final follow-up visit after three months, participants will learn what group they were assigned and given the option to complete the growth hormone therapy if they were originally assigned to the placebo group. Researchers will compare the growth hormone therapy group to the placebo group to identify any potential differences in outcomes.

NCT ID: NCT05588115 Not yet recruiting - Concussion, Mild Clinical Trials

Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion

RACE
Start date: December 2022
Phase:
Study type: Observational

The goal of this observational study is to test if a biosensor can accurately measure a blood biomarker in adult patients presenting to the emergency department with concussion. The main questions it aims to answer are: - Does the biosensor measure the blood biomarker of interest with the same accuracy as the current gold-standard assay technique? - Do relationships exist between blood biomarker measurements from the biosensor and any psychological or physical symptoms of concussion? Participants will be asked to provide blood samples at initial visit and 2-, 6-, and 12-weeks after injury while completing questionnaires at each visit, along with a brief (2 min) daily symptom inventory. Researchers will compare the concussion group to a muscle/skeletal injury group to see if measurements from the biosensor are exclusive to concussion.

NCT ID: NCT04159298 Not yet recruiting - Concussion, Mild Clinical Trials

Cervicogenic Concussion Rehabilitation With TopSpin360

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Concussions occur most frequently in adolescents and often result in significant disruption to daily living for prolonged periods of time. Concussions are an epidemic, with the incidence rates for sports related concussions (SRC) in adolescents up to 0.47 per 1000 athlete exposures. Research would suggest that multi-planar neck strength is a protective factor of SRC risk in adolescents as greater neck strength is associated with a lower SRC risk.(Collins et al) Neck pain is a common symptom associated with SRC that is also associated with prolonged recovery from SRC. (King et al, Van der Naalt et al) Neck pain is also associated with decreased neck muscle strength (DeKoning et al). Our study will address a critical gap in concussion management - multi-planar cervical spine strengthening to specifically rehabilitate the cervicogenic component of prolonged post-concussion symptoms with a cervicogenic component and determine if this approach restores normal neck strength, decreases neck pain and headaches, improves daily global function and allow patients to return to sport and school. work more quickly than those without specific multi-planar neck strengthening.

NCT ID: NCT03481153 Not yet recruiting - Concussion, Mild Clinical Trials

Post-concussion and Transcranial Direct Current Stimulation

Start date: April 2018
Phase: N/A
Study type: Interventional

Children and youth are at a greater risk of concussions than adults, and once injured, take longer to recover. The increased incidence of sports-related concussion in youth and the potentially serious long-term negative impact on their developing brains has enormous repercussions. While most young athletes recover within several days, many continue to experience symptoms for many months post-concussion. Symptoms are wide ranging and include - most notably: headache, sleep disturbances, brain fog, irritability as well as impairments in emotion and cognitive function (i.e. attention, memory, concentration, etc.). Yet there are no evidence-based intervention studies that have successfully addressed these symptoms. Thus, there is an urgent need for improved therapeutic strategies, which promote optimal functional recovery in youth concussion. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neurostimulation technique that can modulate neural excitability in the brain to positively impact cognition, behaviour and mood, particularly when combined with a behavioural intervention. Our long-term goal is to determine whether exercise combined with neurostimulation improves recovery from concussion. However, to our knowledge, the therapeutic potential of tDCS has not been studied in youth with concussion. Our objectives are as follows: 1. To determine the tolerability of a 20-minute session of tDCS in symptomatic youth athletes; 2. To evaluate the association between symptoms and EEG metrics at baseline and following a single session of tDCS in symptomatic athletes and compare these associations in symptomatic athletes who do not receive tDCS.