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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03874208 Recruiting - Clinical trials for Traumatic Brain Injury (TBI)

Prediction for Coma Recovery With Comaweb

COMASCORE
Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury.

NCT ID: NCT03852732 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: February 21, 2019
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03846830 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation

INVENT
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.

NCT ID: NCT03819608 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Start date: October 2020
Phase: N/A
Study type: Interventional

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI and PTSD.

NCT ID: NCT03818451 Recruiting - Clinical trials for Traumatic Brain Injury

Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury

GLIA13
Start date: May 1, 2016
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) typically provokes secondary injury mechanisms, including the dynamic interplay between the ischemic, inflammatory, and cytotoxic processes. Moreover, such an impact induces a substantial level of cell death and results in the degeneration of the dendrites, thereby leading to persistent motor, sensory, and cognitive dysfunction. Previous studies have shown that the adult-born immature granule neurons in the dentate gyrus are the most susceptible of all the cell types in the hippocampus to damage following a moderate TBI due to a controlled cortical impact (CCI) device. Currently, there is no efficient approach available for avoiding immature neuron death or degeneration following TBI. Hence, this study aimed to assess the neuro-regenerative properties of co-ultramicronized PEALut (Glialia®), which is composed of palmitoylethanolamide (PEA) and the flavonoid luteolin (Lut), in an in vivo model of TBI, as well as in patients affected by TBI.

NCT ID: NCT03796936 Recruiting - Clinical trials for Traumatic Brain Injury

3MDR to Treat PTSD With mTBI (3MDR)

3MDR
Start date: January 11, 2019
Phase: Phase 2
Study type: Interventional

Background and Purpose: Posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) are persistent and frequently comorbid complications of recent combat. There is no proven treatment for mTBI, and standard treatments for PTSD frequently achieve only transient, modest impact. Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) is a novel treatment for PTSD combining aspects of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), within the Computer Assisted Rehabilitation Environment (CAREN). The added benefit of the eye movement (EM) component of EMDR is controversial; the purpose of this pilot study is therefore to: 1) obtain an initial estimate of the efficacy of 3MDR in service members with comorbid PTSD and mTBI, and 2) determine the impact of EM on treatment response. The investigators hypothesize that 3MDR will significantly improve symptom severity, both with and without EM. Population: Participants will be active or retired service members with a history of mTBI who meet criteria for probable PTSD on the PCL5. It is anticipated that participants will be recruited through the Center for Neuroscience and Regenerative Medicine (CNRM) Recruitment Core and the National Intrepid Center of Excellence (NICoE). Design type and procedures: This is a pilot, controlled clinical trial in which all 20 participants with comorbid PTSD and mTBI receive 10 sessions (3 preparatory, 6 3MDR treatment, and 1 conclusion), but will be randomized to either include EM (EM+) or not (EM-). In the preparatory sessions, the therapist will help each participant select 2 songs and 14 pictures to be used in their treatment sessions. The therapist will help the participant rate the pictures from least to most impactful. Each 3MDR treatment session will start by playing the first song, to bring them back to the time of their trauma. This will be done while the participant walks on the CAREN's embedded treadmill through the 3MDR virtual environment (VE) projected onto the system's curved screen. This is followed by a display of one of their pictures, a manifestation of their trauma, which they directly face and walk down a hallway toward, until the picture looms before them. The therapist, standing next to the participant along the treadmill's edge, will query the participant about what the picture means to them, how it makes them feel, etc., while the CAREN operator superimposes key words (said by the participant) over the picture, which the therapist later asks the participant to read aloud. Then, for ~60 seconds, the EM+ group will see a red ball "bounce" across the screen in front of the picture, and a number appears on the ball as it touches the screen's edge. The participant will be asked to recite each number aloud. This element is absent for EM- participants. All participants repeats these procedures for 5-7 pictures in each 3MDR treatment session; the pictures used will be agreed upon by therapist and participant, targeting more impactful pictures, whether repeats or new, in later sessions. The pictures are followed by playing the second song, chosen to bring the participant back to present day. The participant will walk at a comfortable pace throughout the session, with each session lasting typically ~60 minutes. The primary outcome measure will be change in PCL-5 score from pre- to post-intervention, with additional measures at 3 and 6 months.

NCT ID: NCT03785600 Recruiting - Clinical trials for Traumatic Brain Injury

Improving Sleep in Veterans With TBI

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

Traumatic brain injury (TBI) is a major cause of disability in the Veteran population, often resulting in chronic pain and sleep disturbances, among other issues. Extensive rehabilitative efforts are usually required and often prevent return to the workforce and community. Disturbed sleep and excessive daytime sleepiness are among the most pervasive and enduring problems after TBI, which the investigators hypothesize is a significant contributor to these functional impairments and an impediment toward rehabilitation. Thus, this research aims to enhance sleep quality as a means to reduce pain and improve quality of life and functional outcome measures in Veterans with TBI. The investigators predict that the proposed intervention, morning bright light therapy, if found effective, will be cost-effective, rapidly deployable, and highly accepted by Veterans with TBI.

NCT ID: NCT03780062 Recruiting - Clinical trials for Treatment by Antiplatelet

Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

PETEChIA
Start date: January 27, 2019
Phase: Phase 3
Study type: Interventional

All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done. No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.

NCT ID: NCT03761641 Recruiting - Clinical trials for Traumatic Brain Injury

Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment

Start date: March 2015
Phase:
Study type: Observational

This protocol is aimed at collecting oculomotor response data from a variety of brain injuries and impairments, and to secondarily evaluate the functionality and ease of use of the NeuroTriage device in the ED in patients with any presumed brain injury and/or impairment. For example, prior studies in adolescents with a concussion have shown that they tend to overshoot the pattern when asked to follow the movement of the lights in the binoculars

NCT ID: NCT03759808 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Treatment for Patients With Chronic Post-Concussion Symptoms

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

The current project will examine the effect of a brief psychological intervention on post-concussion symptoms, neurocognitive function, cerebral blood flow (CBF), and psychophysiological and salivary cortisol markers of autonomic nervous system (ANS) in a sample of 20 participants between 13-25 years of age who experience long-term post-concussive (PC) symptoms 2-9 months post-injury as well as 20 age- and sex-matched controls (non-injured) participants to provide normative data on all the above measures except for concussive symptoms.