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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03315273 Completed - Healthy Clinical Trials

Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.

Start date: November 7, 2017
Phase: N/A
Study type: Interventional

1. Validation of translated Motor Imagery ability questionnaire MIQ-RS 2. Investigating the Motor Imagery ability in patients with traumatic brain injury

NCT ID: NCT03314584 Completed - Clinical trials for Traumatic Brain Injury (TBI)

Managing MTBI-related Headaches With rTMS

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Persistent headache is one of the most common debilitating symptoms in military personnel suffering from mild traumatic brain injury (MTBI). This study aims to assess the long-term effect of repetitive transcranial magnetic stimulation (rTMS) in managing MTBI related headaches for up to 2-3 months by comparing the treatment effect of active-rTMS to sham-rTMS.

NCT ID: NCT03313505 Completed - Clinical trials for Mild Traumatic Brain Injury

PROtein S100B for Mild Trauma of the HEad in Emergency Patients

PROMETHEE
Start date: May 14, 2018
Phase:
Study type: Observational

Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging. The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven. Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first medical contact. Patients requiring this strategy present with focused neurological deficit, Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from anticoagulant therapy are included in this category. Victims of brain injury that do not fall into this category are considered less critical. By definition, mild traumatic brain injury : - a trauma of the cephalic extremity : - whose Glasgow score (30 min after the trauma or during the consultation) is 13-15, - associated with one or more of the following: confusion; disorientation; loss of consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other transient neurological abnormalities (focal signs, epileptic seizures, non-surgical intracranial lesion). Among these patients, some are considered at risk of developing intracerebral lesions. Nevertheless, it should be noted that the prevalence of hemorrhagic complications is radically different between patients with a Glasgow score of 13 and those with a score of 15. Thus, the recommendations suggest a brain scan without injection of contrast media within 4 to 8 hours for patients with the following characteristics : - a retrograde amnesia of more than 30 minutes, - a loss of consciousness or amnesia associated with: - either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, falling by more than one meter), - or an age> 65 years, - or coagulation disorders, including the use of platelet aggregation therapy. Patients who fall outside this definition are considered low risk of complication and should not benefit of imaging. Data from the scientific literature show that an early brain CT-scan allows identification of post-traumatic lesions in this population. Nevertheless, organizational problems, including the availability of the imaging, radiation, and disruption of surveillance related to patient displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT scan is often advocated in patients with mild traumatic brain injury. For example, in the Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to trauma; for 13 (1%) patients, the link with the trauma was uncertain. In fact, the search of alternatives for a safer, more conservative, more efficient practice, one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many teams have been interested in the use of biological variables to guide the decision to use imagery. Among candidate biomarkers, the S100B protein has been the subject of many evaluations which allow it to be used in current practice. Indeed, the increase of the S100B protein carried out within 3 hours following a mild head trauma makes it possible to identify the patients at risk of intracerebral lesion and to target the indications of imaging. The purpose of the registry is to describe the use, interpretation and performance of the S100B protein in its use at bedside in emergency medicine.

NCT ID: NCT03309046 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Interventions for Parent Caregivers of Injured Military/Veteran Personnel

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This randomized clinical trial will test a behavioral caregiving intervention that has been used successfully for dementia and spinal cord injury caregivers to provide services to stressed and burdened parent caregivers of post 9/11 service members/veterans. This intervention is six intensive individual sessions that will teach problem solving, cognitive restructuring and stress reduction targeted to an individual assessment of the care dyad's needs. It will be compared to another method of delivering content, education webinar sessions, which are analogous to the usual standard of care and will function as an attention control arm. The objective of the study is to determine which of these delivery mechanisms is more effective at helping parent caregivers of injured post 9/11 returning troops to improve their depression, anxiety, and burden, and to determine the feasibility of using individual sessions with this population of caregivers.

NCT ID: NCT03307070 Completed - Clinical trials for Major Depressive Disorder

Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury

Start date: September 23, 2017
Phase: N/A
Study type: Interventional

Cognitive behavioral therapy for major depressive disorder (MDD) was adapted for individuals with moderate to severe traumatic brain injury (TBI) (CBT-TBI). A structured, treatment manual was developed. The primary aim is to evaluate the acceptability and tolerability of, and adherence to, CBT-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40). The exploratory aim is to evaluate the potential efficacy of CBT-TBI for MDD in the randomized pilot trial (N=40) and possible moderators and mediators of outcome.

NCT ID: NCT03306563 Completed - Clinical trials for Traumatic Brain Injury

Rapid Biochemical Diagnostics of Traumatic Brain Injury

Start date: December 28, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.

NCT ID: NCT03287557 Completed - Clinical trials for Traumatic Brain Injury

Dysregulated CNS Inflammation After Acute Brain Injury

Start date: January 2, 2018
Phase:
Study type: Observational

By doing this study, the investigator hopes to learn how the levels of important proteins involved in inflammation change over time in patients with acute brain injury. The total amount of time participants will be asked to volunteer for this study is approximately two hours over a five day period.

NCT ID: NCT03277859 Completed - Clinical trials for Traumatic Brain Injury

Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)

SAA-TBI
Start date: August 16, 2017
Phase: N/A
Study type: Interventional

The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.

NCT ID: NCT03265912 Completed - Clinical trials for Mild Traumatic Brain Injury

Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment

Start date: January 26, 2017
Phase:
Study type: Observational

mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. This study purpose is to study this BNA technology in individuals who have sustained a concussion.

NCT ID: NCT03261674 Completed - Clinical trials for Traumatic Brain Injury

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Start date: June 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).