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Brain Injuries clinical trials

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NCT ID: NCT02368366 Completed - Brain Injuries Clinical Trials

Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI

Start date: November 2014
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction. The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST.

NCT ID: NCT02367521 Completed - TBI Depression Clinical Trials

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)

rTMS TBI
Start date: March 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.

NCT ID: NCT02367300 Completed - Brain Injuries Clinical Trials

Validation Of TBI Detection System For Head Injured Patients

B-AHEAD III
Start date: February 2015
Phase: N/A
Study type: Observational

A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

NCT ID: NCT02367274 Completed - Brain Injuries Clinical Trials

Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department

READ-TBI
Start date: January 2015
Phase: N/A
Study type: Observational

A prospective, non-randomized trial for the extension and replication of the development database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

NCT ID: NCT02354469 Completed - Brain Injuries Clinical Trials

The Effects of Head Trauma on Collegiate Athletes

Start date: August 2015
Phase:
Study type: Observational

Recently, researchers and clinicians have examined many different forms of concussion testing aimed to assess if a brain injury has occurred and to what degree it affects the individual being tested. Due to the multifaceted and complex presentation of concussive injuries and the unknown effects of repeated head trauma, it is unlikely that a single test of physiological or behavioral function will reflect the full range of injury-related damages from a concussive event or from a series of cumulative head traumas, as well as the injury response within brain tissue. However, by combining a variety of objective assessments which may detect structural and functional alterations following head trauma into a single study, a clearer understanding of the multi-faceted presentation resulting from head trauma may be identified. The identification of biomarkers and the utilization of objective and clinically feasible tools will provide a method to assess three domains across multiple systems affected by head trauma: 1) the prognostic value of initial concussion assessments to identify injury severity and factors responsible for prolonged recovery, 2) the temporal window of recovery and potential vulnerability of brain tissue post-injury, and 3) the long-term alterations associated with repeated head trauma exposure.

NCT ID: NCT02352441 Completed - Clinical trials for Traumatic Brain Injury

Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

ACTION
Start date: June 2016
Phase: N/A
Study type: Interventional

Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy instruction (MSI) to help patients self-regulate their behavior though a goal management process - identifying a goal, anticipating performance problems, generating possible solutions, self-monitoring performance during the activity, recognizing maladaptive task strategies, stopping and then modifying real-time task behavior by choosing an alternate strategy. MSI alone often does not result in improved daily functioning because it requires conscious cognitive oversight to employ (which is difficult for people with executive dysfunction) and it presumes that simply establishing goals propels goal-directed action, when for many people, this is not so. Social psychologists report that people who set implementation intentions (if-then statements that link specific situational cues with specific goal actions) are more likely to perform goal actions than those who only set goal intentions. Implementation intentions are believed to be effective because they enable people to switch from conscious-effortful reflective action control to automatic, reflexive action control associated with selected situational cues. A team of researchers from the Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and performance on a task that challenges executive function using a small randomized controlled trial. If the results are positive, a larger study would be conducted to determine the impact of ACTION sequence training on SM performance on military-relevant tasks and goals.

NCT ID: NCT02350894 Completed - Brain Concussion Clinical Trials

Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury

Start date: January 2015
Phase:
Study type: Observational

This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.

NCT ID: NCT02339220 Completed - Clinical trials for Traumatic Brain Injury

The Brave Initiative: Bringing Rehabilitation to American Veterans in an Enriched Environment

TBI
Start date: September 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the value of Constraint-Induced Movement therapy (CIMT) for improving motor function and general fitness in adults with subacute and chronic traumatic brain injury (TBI), particularly TBI acquired during active military duty, in comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the effect of a set of enhanced versus "standard" procedures for transferring therapeutic gains from treatment setting to everyday life. Lastly, this study will determine whether any therapeutic effects observed are correlated with neuroplastic white matter or grey matter changes.

NCT ID: NCT02337114 Completed - Clinical trials for Brain Injuries, Traumatic

Recovery Enhancement From Traumatic Brain Injury Using Acceptance and Commitment Therapy - a Pilot Study.

REACT
Start date: January 2015
Phase: Phase 0
Study type: Interventional

Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression, anxiety and low self awareness. A key factor in recovery is adjustment to the effects of injury. Psychological intervention may facilitate this change; however what works is unclear. ACT seeks to improve psychological flexibility; the ability to be present with difficult thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what we believe we should be. Current research is limited, but what is published suggests it may be useful for this group. Due to the limited research this pilot study aims to conduct preliminary analysis on the acceptability and feasibility of ACT for people with sTBI whilst also examining the suitability of the study protocol in order to make recommendations for future studies. Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be recruited, one of which will serve as the intervention centre. Clients in the intervention group will be asked to complete questionnaires a week before and after participation in the 6 week ACT programme. Clients in the comparison group will be asked to complete questionnaires a week before and after receiving 6 weeks of treatment as usual (TAU). The treatment group will also receive TAU. All participants will be invited to participate in a focus group at the end of this 8 week period to discuss their involvement in the study. Staff will be asked to complete a parallel version of one of the client questionnaires within a similar timeframe. In addition staff at the intervention centre will be invited to attend a focus group and complete an additional questionnaire after the eight week period.

NCT ID: NCT02331901 Completed - Brain Concussion Clinical Trials

Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

Start date: December 2014
Phase: N/A
Study type: Observational

This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI