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Concussion, Brain clinical trials

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NCT ID: NCT04074486 Completed - Brain Injuries Clinical Trials

Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

BSC-CI-NPC
Start date: October 2, 2019
Phase:
Study type: Observational

This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).

NCT ID: NCT03966404 Completed - Clinical trials for Mild Traumatic Brain Injury

EyeBOX Concussion Study and Registry

Start date: August 5, 2019
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.

NCT ID: NCT03963804 Completed - Clinical trials for Brain Injuries, Traumatic

Objective Brain Function Assessment of mTBI/Concussion

CAS13-25
Start date: June 11, 2018
Phase:
Study type: Observational

This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

NCT ID: NCT03895450 Completed - Clinical trials for Mild Traumatic Brain Injury

Treating Persistent Post-concussion Symptoms With Exercise

Start date: May 24, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to investigate an aerobic exercise program as a treatment for adults with persistent post-concussive symptoms (PPCS) following mild traumatic brain injury. In this delayed-start trial participants will be initially randomized into either a 6-week low-impact stretching protocol or 12-week aerobic exercise protocol. Following the completion of the stretching protocol participants will continue on to complete the aerobic exercise protocol in full. 56 participants aged 18-65 yrs will be recruited from the Calgary Brain Injury Program (CBIP), including the Early Concussion Education Program at Foothills Medical Centre, Calgary Pain Program, University of Calgary Sports Medicine Centre acute concussion clinic and a physiotherapy clinic (Tower Physio) all of which are located in Calgary, Alberta, Canada. Participants will complete an online follow up (symptom questionnaires and questions regarding exercise behaviour) 3 and 9 weeks post intervention.

NCT ID: NCT03844282 Completed - Concussion, Brain Clinical Trials

Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return

RESCUE-RACER
Start date: November 9, 2018
Phase:
Study type: Observational

RESCUE-RACER is jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. The RESCUE-RACER programme evaluates motorsports competitors at baseline (CArBON) and post-injury (CARS). The CArBON study (Competitor Assessment at Baseline; Ocular, Neuroscientific) collects a battery of neuroscientific data in a baseline assessment. The CARS study (Concussion Assessment and Return to motorSport), repeats the CArBON battery throughout the recovery period in competitors who sustain a potentially concussive event during motorsport. The primary outcome of the RESCUE-RACER programme is to establish the natural history of concussive symptoms and signs in motorsport competitors using a comprehensive neuroscientific battery. The standard clinical assessment of concussive symptoms will be correlated with objective clinical scoring, in addition to neurocognitive and neuropsychological assessments. Advanced brain imaging with MRI will be used to further characterize head injuries in motorsport. Finally, salivary biomarkers will be collected to monitor the measurable biological effects of a potentially concussive event immediately following injury and through recuperation in the recovery period. The secondary outcome is investigation of a novel diagnostic tool for concussion, in the form of a 3D head-mounted display and eye tracking system capable of assessing ocular, vestibular and reaction time (OVRT) functions (the I-PAS device, now re-named Dx 100). The results of RESCUE-RACER will form an evidence base for medical decision-making track side after a potentially-concussive incident and will advise on clinic management of motorsports concussion, including the important 'return-to-race' decision.

NCT ID: NCT03691272 Completed - Headache Clinical Trials

rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head

TOPiCS-rTMS
Start date: April 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to investigate the treatment effect of repetitive transcranial magnetic stimulation in patients with a history of both persistent post-traumatic headache and post-concussion symptoms. In this double-blind, sham-controlled, concealed allocation, randomized clinical trial, 20 patients aged 18-65 yrs will be recruited from the Calgary Brain Injury Program (CBIP) and the Calgary Headache Assessment and Management Program (CHAMP) / Calgary Chronic Pain Centre, Calgary, Alberta, Canada. Patients will engage in a two-week rTMS treatment protocol (10 treatments) and will be followed for 6 months after therapy.

NCT ID: NCT03677661 Completed - Clinical trials for Mild Traumatic Brain Injury

Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury

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

Neck pain, dizziness and headache are common symptoms following mild traumatic brain injury (mTBI). The efficacy of cervical spine and vestibular-ocular system impairments intervention need to be determined. In this randomized clinical trial, a 6-week personalized clinical rehabilitation program on subacute mTBI will be compare to a conventional approach. The rehabilitation program will include cervical spine exercise combined with manual therapy as well as vestibular-ocular rehabilitation. Overall symptoms will be measured by the Post-Concussion Symptoms Scale (PCSS). Disability and symptoms severity related with neck pain, headache and dizziness will also be evaluated after the treatment period and at 6-week post-treatment.

NCT ID: NCT03671083 Completed - Clinical trials for Brain Injuries, Traumatic

Validation of Brain Function Assessment Algorithm for mTBI/Concussion

CAS13-25V
Start date: October 1, 2018
Phase:
Study type: Observational

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

NCT ID: NCT03564210 Completed - Concussion, Brain Clinical Trials

The Effect of Screen Time on Recovery From Concussion

Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This study will prospectively examine the effect of screen time on recovery from concussion. Patients 12 to 25 years of age presenting to the ED with a concussion will be randomized to allow for screen time as tolerated or to abstain from screen time for the first 48 hours of recovery. The amount of screen time use and duration of concussive symptoms will be assessed through daily surveys and a daily post-concussive symptom score (PCSS).

NCT ID: NCT03478059 Completed - Concussion, Brain Clinical Trials

Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.