Clinical Research Directory

Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain

Assess the feasibility of recruiting, enrolling and randomizing patients with concussion symptoms and neck pain to receive manual therapy and cervical rehabilitative exercises in addition to standard concussion treatment. In the usual care workflow provided at the participating concussion clinic, cervical spine rehab is not typically introduced until after week 4. The rationale is that neck pain is often a self-limiting condition that may resolve spontaneously, without the need for specific cervical spine rehab. This study is chiefly focused on feasibility aims that revolve around developing changes to barriers in workflow issues at the participating concussion clinic, that would allow for earlier introduction of cervical spine rehab.

Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.

Exercise Reset for Concussion in a Military Environment

Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery. We will conduct a prospective four-year multicenter mechanistic treatment (Phase 3) RCT in CSM of personalized sub-threshold aerobic exercise added to the PRA compared with the PRA alone. Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise.

Concussion Recovery and Support Program

Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-29 yo with concussion/ mild TBI.

Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)

The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry

Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.

Problem-Solving Training for Concussion

Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.

Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk

The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.

Exercise in Postconcussion Symptoms and Posttraumatic Headache

The goal of this clinical trial is to compare two models of delivery of guided exercise in patients with exercise intolerance after mild head injury. The main question it aims to answer is: • Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a program with telephone-based follow-up only? Participants will undergo a treadmill test to determine eligibility for the study, and to determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to be the symptom threshold. One group will receive face-to-face folllow-up and repeated testing, one group will receive telephone-based follow-up only . Researchers will compare these two groups to see if closer follow-up is superior when it comes to recovery from exercise intolerance after 12 weeks of exercise.

Get Going After concussIonN Lite

Background: Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative. Aims: 1. To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: "Get going After concussion Lite" (GAIN Lite). 2. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load. Methods: A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.

Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process

Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.

ERP Changes Pre and Post Military Changes

This study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.

The s100β Levels in Patients With Mild Brain Injury.

Mild traumatic brain injury (TBI) accounts for the majority of TBI. At present, whether TBI has traumatic intracranial lession is mainly diagnosed by computed tomography (CT), while only 5% of mild TBI has positive CT results. The risk stratification method for patients with mild TBI is needed to reduce unnecessary CT use and reduce medical costs. S100β is a protein in glial cells and can be used as a biomarker of brain injury. S100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild TBI patients in Europe and the United States. However, it was showed to have difference between races, and there lacks systematic research data from Chinese population. In addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods. This study is based on a novel fast S100β test. The reference intervals of S100β in Chinese adults will be established. Further, evaluation of S100β in diagnosis of traumatic intracranial lesions in acute mild TBI will be conducted from the perspective of clinical and economic value in China, which will provide data for screening of low-risk TBI patients and avoiding unnecessary CT use in clinical practice.