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Brain Injuries clinical trials

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NCT ID: NCT05790278 Enrolling by invitation - Breast Cancer Clinical Trials

Purpose in Life Survey

PIL
Start date: August 1, 2022
Phase:
Study type: Observational

At present, there is no empirical data that specifies the likely prevalence of purpose in life disruption among various clinical populations. Between one-third and one-half of cancer survivors report some degree of existential distress during or after their treatment, but these findings are not specific to the domain of purpose in life. To address the aforementioned gap, we propose to conduct a survey study to determine the prevalence of purpose disruption in two clinical populations and determine if the prevalence of purpose disruption in these populations is different from that of a normative population.

NCT ID: NCT05786729 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Aerobic Exercise After Traumatic Brain Injury

AER-TBI1
Start date: January 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.

NCT ID: NCT05713942 Enrolling by invitation - Brain Concussion Clinical Trials

Concussion Assessments in Football

Start date: January 1, 2021
Phase:
Study type: Observational

Diagnosing and determining the severity of a sports-related concussion immediately on- or off-field is challenging, especially because clinical signs can evolve minutes to hours after the mechanism of injury. Hence, repeated follow-up and serial assessments of a player are recommended following such an injury. Current advice, when a player sustains a confirmed or suspected concussive injury, is to remove them from play immediately and not return to competition or unrestricted training until signs and symptoms have been managed as per relevant guidelines. To support this decision the International football Association Board has introduced a trial allowing an additional permanent concussion substitution in participating competitions. Follow-up assessment of concussion incidents is recommended to include the Sport Concussion Assessment Tool 5th Edition. For further assessment of neurocognitive deficits and to inform return to play decisions, it is recommended that a computerised assessment is also adopted, such as the Immediate Post-Concussion Assessment and Cognitive Testing tool. The aims of this study are: 1. To determine the incidence of head trauma and use of concussion substitutions in football competitions that are participating in the IFAB's permanent concussion substitution trial. 2. To evaluate the immediate severity of reported concussion signs and symptoms for football players with a confirmed or suspected concussion. 3. To evaluate the ability of neurocognitive assessments completed post-incident to inform the clinical diagnosis of concussion.

NCT ID: NCT05665764 Enrolling by invitation - Clinical trials for Sleep Initiation and Maintenance Disorders

The Feasibility of Home-Based Measurement of Circadian Timing for Veterans With TBI and Insomnia

Home DLMO
Start date: July 1, 2023
Phase:
Study type: Observational

Veterans with traumatic brain injury (TBI) frequently experience insomnia, which is linked with delayed TBI recovery, more severe functional impairment, and exacerbation of disabling TBI after-effects such as depression, chronic pain, and fatigue. Current research suggests that TBI can impact numerous systems involved in sleep, suggesting that insomnia can have various causes and that a "one-size-fits-all" approach to treatment is likely inadequate. As such, it is necessary to determine which Veterans may benefit from standard evidence-based treatments, such as Cognitive Behavior Therapy for Insomnia, and which may require enhanced treatments targeting specific underlying mechanisms. An emerging body of evidence has established a link between circadian rhythm disruption and post-TBI insomnia. A mismatch between circadian and desired sleep timing (i.e., "circadian misalignment") is common following TBI, as evidenced by disruptions of key circadian rhythms involved in sleep regulation (e.g., melatonin production), as well as the onset of circadian rhythm sleep-wake disorders. Importantly, circadian-driven sleep disturbances require specialized treatments that target circadian rhythms (i.e., "chronotherapies"), such as timed sleep windows or enhanced light exposure, as standard treatment approaches can fail to address or even exacerbate the underlying circadian misalignment. Thus, circadian misalignment represents a novel and modifiable treatment target and has the potential to improve functional outcomes in Veterans with TBI and insomnia. Detection of circadian misalignment and optimal use of chronotherapies require the ability to measure circadian phase (i.e., timing of the central circadian clock). However, current sleep medicine in TBI is hampered by a lack of pragmatic options for measuring circadian phase. This is because laboratory dim light melatonin onset (DLMO), the gold standard measure of circadian phase, is time and cost prohibitive, requiring specialized sample (e.g., saliva) collection facilities and placing substantial burden on the patient. Recently, novel methods of DLMO measurement have been developed that may enhance the accessibility and practicality of circadian phase assessment, although, as of yet, they have not been used in Veterans with TBI. The proposed single-arm, longitudinal study seeks to evaluate the feasibility of two methods of measuring DLMO in the home environment of Veterans with TBI and insomnia: 1) direct measurement of self-collected salivary melatonin; and 2) indirect estimation of DLMO using activity and light-exposure data collected through actigraphy. Additionally, this study seeks to explore the relationships between circadian misalignment, sleep disturbance, and functional impairment in Veterans with TBI. The specific aims of this study are to: Aim 1) evaluate the feasibility of two methods of home DLMO measurement (i.e., self-collected salivary melatonin and actigraphy data) in Veterans with TBI and insomnia; and Aim 2) examine associations between circadian misalignment (i.e., the difference in timing between DLMO and attempted sleep onset), sleep disturbance, and functional impairment. Veterans with TBI and insomnia will be asked to wear a wrist-based actigraphy device for one week, which will collect data on light exposure and sleep-wake states. They will then be asked to self-collect seven hourly saliva samples under dim light conditions in their own home and mail them to a testing facility using a provided pre-paid shipping label. Saliva samples will be used to directly measure DLMO and actigraphy data will be used to indirectly estimate DLMO using established mathematical models of the human circadian pacemaker. Evaluating the feasibility of home DLMO measurement is a crucial first step for enhancing precision sleep medicine for Veterans with TBI and insomnia. Findings will inform the development and testing of tailored sleep interventions for use with this patient population.

NCT ID: NCT05542108 Enrolling by invitation - Premature Birth Clinical Trials

Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants

NTM
Start date: September 7, 2021
Phase: N/A
Study type: Interventional

This project is a Randomised Clinical Trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders. This is a study will be based on the adaptation of the intervention previously described and published by Guzzetta and colleagues (2009), and will include an improved and increased kinesthetic component, to be performed in infants born very prematurely and preterm infants with a documented brain injury. The intervention will start in neonatology during the infant hospitalization and continue at the child's home until two months of correct age.

NCT ID: NCT05527041 Enrolling by invitation - Clinical trials for Mild Traumatic Brain Injury

A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings

Start date: July 1, 2023
Phase:
Study type: Observational

The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings. The EBLens will be based on a concussion diagnostic algorithm from the FDA cleared EyeBOX device, developed by Oculogica, and eye-tracking data collected from a wearable set of eye-tracking glasses, developed by Adhawk Microsystems. Once the EBLens is prototyped, an algorithm for diagnosing concussion will be developed that is specifically appropriate for the EBLens via a case-control clinical study comparing 100 concussed to 100 non-concussed subjects (Phase I). Participants, age 18-35 years, will be recruited from the KACH research team and affiliated providers and clinical sites. Concussed individuals will be assessed within 72 hours of concussion. Demographics, basic medical history, symptom severity, a visio-vestibular exam and the EBLens scan will be collected on both injured cases and uninjured controls at a single time point. The algorithm and the EBLens will be validated in a subsequent, prospective cohort validation study (Phase II) designed for FDA submission. The correlation of the EBLens output with resolution of symptoms will also be observed in longitudinal follow-up of concussed participants in the validation study. The participant population for this study will be cadets recruited from the USMA and young athletes recruited from affiliated sites during baseline concussion testing. Participants will be assessed at baseline at the start of their academic year or sports season. Those participants who experience a concussive injury will be assessed again at three time points; 1) within 72 hours of injury, 2) weekly until and at the time of initiation of a graded return to activity protocol, and 3) upon clearance for unrestricted RTP/RTD.

NCT ID: NCT05499806 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Cohort Study on the Effects of Aging in Acquired Brain Injury Patients

BRAINReADAPT
Start date: March 18, 2022
Phase:
Study type: Observational [Patient Registry]

A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.

NCT ID: NCT05450237 Enrolling by invitation - Stroke Clinical Trials

Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation (NeuroPsyc)

NeuroPsyc
Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

The presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, Multiple Sclerosis, Parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. The evaluation of certain domains may be more difficult so, specific assessment tools are necessary to analyze them.

NCT ID: NCT05201833 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

TRACK-TBI Longitudinal Biomarker Study

TRACK-TBI BIO
Start date: March 1, 2022
Phase:
Study type: Observational

The overarching goal of this study is to improve understanding of the long-range natural history of TBI by extending follow-up of a previously enrolled cohort (TRACK-TBI) beyond the first 12 months after injury.

NCT ID: NCT05034718 Enrolling by invitation - Brain Injury Clinical Trials

Implementation of the Pittsburgh Infant Brain Injury Score

PIBIS
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

This is an implementation study of the Pittsburgh Infant Brain Injury Score (PIBIS) into the UPMC Children's Hospital of Pittsburgh emergency department. Children less than 1 year of age presenting to the CHP ED for symptoms which place them at increased risk for AHT as defined in the PIBIS validation study will be potentially eligible.