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Mild Traumatic Brain Injury clinical trials

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NCT ID: NCT05425251 Recruiting - Clinical trials for Mild Traumatic Brain Injury

BRAINI-2 Elderly Mild TBI European Study

BRAINI2ELDER
Start date: March 1, 2022
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.

NCT ID: NCT05365776 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

GET-FAB
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.

NCT ID: NCT05262361 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Persistent Post-Concussion Symptoms With Convergence Insufficiency

PPCS-CI
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of office-based vergence and accommodative therapy (OBVAT) that is effective in remediating symptoms. Adolescent and young adult concussion is considered a substantial health problem in the United States where our team has shown that about half of patients with persistent post-concussion symptoms have convergence insufficiency (PPCS-CI), causing significant negative impact associated with reading or digital screen-related activities, and is believed to be one factor causing delayed recovery impacting return to school, sports, or work. The results of this randomized clinical trial will impact the lives of adolescents and young adults with PPCS-CI to guide professionals on how to manage and treat those with PPCS-CI by 1) comparing the differences between PPCS-CI and TYP-CI, 2) discovering the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and 3) determining the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.

NCT ID: NCT05233475 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Get Going After concussIonN Lite

GAIN Lite
Start date: February 13, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05194644 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Sensorimotor Stimulation, Routine Physical Therapy, Balance, Cognitive Performance Mild Traumatic Brain Injury Patients

Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Study design: Randomized controlled trial Settings: Physiotherapy department of Allied hospital, Faisalabad Sample size: 27 in each group Control group receive: Routine physical therapy Experimental group receive: Routine physical therapy+ Sensorimotor stimulation

NCT ID: NCT05086419 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

This Randomized Controlled Trial (RCT) will explore the effect of sub-symptom threshold aerobic exercise on persistent post-concussion symptoms and exercise intolerance in patients with mild Traumatic Brain Injury (TBI). The hypothesis is that sub-symptom training will reduce the symptom pressure, normalize exercise tolerance, reduce patient-specific activity limitations and improve health-related quality of life. To improve the chances of conducting a high-quality RCT, a feasibility trial will be completed prior to the definitive RCT.

NCT ID: NCT05049057 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

Start date: July 19, 2022
Phase: Phase 2
Study type: Interventional

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

NCT ID: NCT05048966 Recruiting - Dementia Clinical Trials

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

Start date: December 8, 2022
Phase: N/A
Study type: Interventional

Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.

NCT ID: NCT04995068 Recruiting - Clinical trials for Traumatic Brain Injury

Score Predicting Lesion Development on CT Following Mild TBI

SELECT-TBI
Start date: March 1, 2021
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) is one of the most common reasons behind emergency department (ED) visits. A small portion of mTBI patients will develop an intracranial lesion that might require neurosurgical intervention. Several guidelines have been developed to help direct these patients for head Computerized Tomography (CT) scanning, but they lack specificity, mainly focus on ruling out lesions, and do not estimate the risk of lesion development. The aim of this retrospective observational study is to create a risk stratification score that predicts the likelihood of intracranial lesion development, lesion progression, and need for neurosurgical management in patients with mTBI presenting to the ED. Eligible patients are adults (≥ 15 years) with mTBI (defined as admission Glasgow Coma Scale (GCS) 13-15) who presented to the ED within 24 hours of injury to any ED in Stockholm, Sweden between 2010-2020. Reasons for ED visit and Internal Classification of Disease (ICD) codes will be used to screen for patients. Machine-learning models will be applied. The primary outcome will be a traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. The secondary outcomes will be any clinically significant lesion, defined as an intracranial finding that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission > 48 hours due to the TBI, or death.

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.