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Brain Injuries, Traumatic clinical trials

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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: NCT02331628 Completed - Clinical trials for TBI Traumatic Brain Injury

ESWT as a Treatment for Chronic NHO in TBI Patients

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

Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.

NCT ID: NCT02331615 Completed - Clinical trials for Traumatic Brain Injury

Application of Trans Cranial Direct Current Stimulation for Executive Dysfunction After Traumatic Brain Injury

Start date: March 2013
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often suffer from executive dysfunction and behavioral disturbances. These types of injuries often involve axonal damage to pre frontal brain areas, which mediate various cognitive and behavioral functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction, orbitofrontal circuit lesions lead to personality changes characterized by disinhibition and anterior cingulate circuit lesions present with apathy. Patients who suffered traumatic frontal lobe damage often demonstrate a lasting, profound disturbance of emotional regulation and social cognition. Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes in the human motor cortex. this effect depends on the stimulation polarity and is specific to the site of stimulation. Interacting with cortical activity, by means of cortical stimulation, can positively affect the short-term cognitive performance and improve the rehabilitation potential of neurologic patients. In this respect, preliminary evidence suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect, and other cognitive disorders. Several possible mechanisms can account for the effects of tDCS and other methods on cognitive performance. They all reflect the potential of these methods to improve the subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks. It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk during ambiguous decision making. In this tDCS study the investigator uses one anode and one cathode electrode placed over the scalp to modulate a particular area of the central nervous system (CNS). The stimulation is administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on people.Electrode positioning is determined according to the International EEG 10-20 System.

NCT ID: NCT02310633 Completed - Clinical trials for Traumatic Brain Injury

Developing Process-Specific Verbal Memory Interventions for Veterans With Tramatic Brain Injury (TBI)

DPSVM
Start date: January 5, 2015
Phase: N/A
Study type: Interventional

Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research & Development (RR&D) and represents a critically important public health problem facing the Veteran population. Developing efficacious treatments for persistent memory deficits seen in this population is a key step in reducing the impact that such problems have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple alternative treatments individually matched to the Veteran's key deficits, and by research that seeks to understand the cognitive and neural basis of treatment-related change over time. The results of this approach may aid clinical decision making and assignment of patients to rehabilitative treatments most likely to improve memory capacity and functional outcome.

NCT ID: NCT02278367 Completed - Depression Clinical Trials

Clinical Evaluation of Flortaucipir F 18

Start date: December 2014
Phase: Phase 2
Study type: Interventional

This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.

NCT ID: NCT02276079 Completed - Brain Concussion Clinical Trials

The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury

Start date: February 17, 2015
Phase: N/A
Study type: Interventional

The study is a "proof-of-principle" project to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). The study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).

NCT ID: NCT02270736 Completed - Stroke Clinical Trials

Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability

SIPEXI
Start date: February 9, 2015
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.

NCT ID: NCT02267668 Completed - Clinical trials for Traumatic Brain Injury

Subsymptom Threshold Exercise Protocol Following Mild TBI

STEP
Start date: July 1, 2014
Phase: N/A
Study type: Interventional

The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI).