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Brain Injury, Chronic clinical trials

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NCT ID: NCT05917665 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Early Digital, Analyte and Neurologic Biomarkers of Acute and Chronic Brain Injury and Recovery in CQT Instructors

Start date: June 2024
Phase:
Study type: Observational

Repetitive blast exposure has been shown to lead to more severe neurobehavioral impairments versus a single exposure. Blast-induced Traumatic Brain Injury (TBI) can lead to short- and long-term adverse outcomes Even mild brain injuries can impair neurocognitive performance, and repeated injuries can amplify negative outcomes. Service members with repeated exposure to low-level blasts as a necessary part of their job or training display altered neural activity during a memory task that is paralleled by a reduction in accuracy on neurocognitive memory tasks. As a result, it is important to monitor service members that are exposed to multiple blast-generated mTBIs to allow the earliest identification of acute or chronic brain and body insult and provide individualized measures of time to recovery. While TBI is clinically diagnosable, the methods of diagnosis have up to now been typically expensive and immobile, and treatments and interventions sparse. The investigators will conduct a longitudinal assessment of mTBI brain biomarkers by collecting repeated measures of FDA approved mTBI brain injury biomarkers, correlated with sound and blast exposure, as well as continuous monitoring through smart watches (activity, sleep, biometrics, calorie expenditure, balance) and analyte data through analyte sensors (glucose, lactate, ketones). Study data will be organized into categories and presented to participants daily within the application and will be securely stored within the application. At the completion of the study, participants will be provided with the study data digitally within the mobile application and study data will also be provided to the credentialed unit medical provider to enable it to be ported to the participants' electronic medical record. This study will create a continuous record of blast overpressure and sound exposures and correlate those to the participants health state over the course of several 9-week courses. This will enable an assessment of individualized susceptibility to brain injury as well as providing novel data on time to recovery. The investigators hope to develop dynamic and accurate risk profiles that are individual and will lead to further understanding of how to protect participants from mTBI (mild TBI) events.

NCT ID: NCT05740553 Terminated - Stroke Clinical Trials

Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury

ReTrieve
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

Researchers aim to determine whether the ReTrieve system for tactile training can improve tactile function (sense of touch) in the hand after brain injury when used at home for 6 weeks.

NCT ID: NCT05435404 Completed - Cerebral Stroke Clinical Trials

Qualitative Study Patient & Physician Experiences Botox COVID-19

QualBotoxCov
Start date: October 8, 2021
Phase:
Study type: Observational

During the COVID-19 pandemic and subsequent series of Lockdowns, clinic out-patient spasticity services were replaced with video based tele-consultation appointments, in order to reduce the potential risk of virus transmission between patients and clinicians in either direction. This meant that for an extensive period of time, this treatment could not be offered, and like many other specialist services, this resulted in a backlog of case referrals and an extensive clinic waiting list, where patient appointments and referrals were delayed by the pandemic. There have been discussions in many professional network forums that have suggested that the necessary changes to appointments during the pandemic may have contributed to a build-up of pain and disability for patients who were unable to access spasticity management treatment when they needed it. This research aims to gain insight and understanding of the individual experiences and perceptions of patients, carers and a physician who have been involved in spasticity treatment out-patient service clinics during and post COVID 19 pandemic. To do this, a qualitative research approach has been adopted and a group of 10 potential participants along with one consultant physician will be invited to participate in the study. Participants will be provided with information on the research (Participant Information Sheet) and asked to provide written informed consent (Consent Form) in order to take part. After providing consent, the participant will be interviewed via telephone. Data will be analysed using a thematic approach by the research team to identify the challenges, opportunities and barriers that may have been encountered during the pandemic and post pandemic period. All participants will be provided with a debrief document.

NCT ID: NCT04949607 Completed - Clinical trials for Brain Injuries, Traumatic

Traumatic Brain Injury and the Gut Microbiome

Start date: July 28, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.

NCT ID: NCT04798859 Completed - Rehabilitation Clinical Trials

The Child in Context Intervention Study

CICI
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Children with acquired brain injury (ABI) often struggle with complex impairments, including cognitive (such as memory and attention), social, emotional and behavioral challenges. There is a lack of evidence-based knowledge about rehabilitation for children with ABI in the chronic phase. The current study, the CICI Study, is a randomized controlled trial (RCT) directed towards children with ABI and their families in the chronic phase. The study will be conducted in close collaboration with schools and local health care providers. The CICI Study focuses on the child's and parents' individually identified target outcome areas and rehabilitation goals. The intervention aims to enhance everyday functioning in the home and school environment by attaining rehabilitation goals in areas noted as challenging by the participants. The efficacy of the CICI-intervention will be measured in terms of goal attainment, burden of brain injury related symptoms, parenting self-efficacy, unmet health care needs, as well as several aspects of child, parent and family functioning.

NCT ID: NCT04710147 Completed - Clinical trials for Brain Injury, Chronic

Cross-cultural Adaptation to the Spanish Population and Validation of the Community Balance & Mobility Scale (S-CB&M)

S-CB&M
Start date: February 9, 2021
Phase:
Study type: Observational [Patient Registry]

Due to acquired brain injury (ABI), is often difficulty in gait and balance alterations, as problems that patients designated as the most disabling. It is essential to an effective assessment of the balance. Objective: The purpose of the present project adapt and verify the validity of the scale Community Balance and Mobility (CB&M), in patients with ABI in subacute and chronic stage, since that is postulated as a brief tool and covering the peculiarities of the specific alterations of the patient after suffering brain injury. Methodology: Between February 2021 and June 2022 will be transcultural adaptation to the ABI population and validation of psychometric scale CB&M in three phases. 100 subjects who receive treatment in centers of attention to brain injury in Spain will be recruited. Results: validity and reliability parameters shall be calculated by means of descriptive statistics for each item of the scales and the set of scale score. Investigators will also analyze the internal consistency using Cronbach's alpha, the interclass correlation coefficient will be used to determine the reliability, and the items will be scanned with the Pearson coefficient: > 0.20, among other parameters.

NCT ID: NCT04331392 Recruiting - Clinical trials for Brain Injuries, Traumatic

Online Memory Intervention for Individuals With Traumatic Brain Injury

Start date: October 30, 2018
Phase: N/A
Study type: Interventional

This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and brain health in individuals who have sustained moderate-severe traumatic brain injury.

NCT ID: NCT03273062 Recruiting - Brain Injuries Clinical Trials

A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury

Start date: July 20, 2017
Phase: Phase 2
Study type: Interventional

This is a follow-up study for an ongoing open label trial conducted by the Sheppard Pratt-Lieber Research Institute utilizing the catechol-O-methyl-transferase (COMT) inhibitor Tolcapone to evaluate its effects on cognition and neuropsychiatric symptoms in patients with brain injuries (BI). In this study, investigators will conduct a double-blind, placebo-controlled clinical trial utilizing a crossover design to study the effects of two weeks of Tolcapone 200mg administered three times a day (total of 600mg/day) on cognitive performance. Physical, emotional, cognitive and social functioning will also be evaluated through participant and proxy report. The investigators are planning to randomize a total of 12 patients with a history of acquired brain injury (BI).

NCT ID: NCT02979743 Recruiting - Cerebral Palsy Clinical Trials

MRI-based Neuroimaging Predictors of Clinical Improvements Following Therapy in Children With Cerebral Palsy

Start date: December 2016
Phase: N/A
Study type: Interventional

The aim of this study is to explore the relationship between brain MRI-metrics and hand function observed in children with cerebral palsy (CP),compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictor of clinical improvement following therapy in children with CP.

NCT ID: NCT02977624 Completed - Clinical trials for Brain Injury, Chronic

A Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury

Start date: December 2016
Phase: N/A
Study type: Interventional

Objectives - To evaluate the effectiveness of an telerehabilitation intervention program among acquired brain injury (ABI) survivors in the chronic phase. The aim of the intervention is to improve the transition from rehabilitation units to community dwelling and facilitate activity and participation in life roles in the community. Working hypothesis - The telerehabilitation based program for ABI survivors will be effective in: 1. Improving function in activities of daily living, participation in occupations and health related quality of life. 2. Reducing the need for outpatient clinic and rehabilitation services. 3. The intervention achievements will be maintained in 3-month follow-up Methodology - Participants: ABI survivors will be selected from patients who are referred to the outpatient or home-based rehabilitation unit of Maccabi health services. Following completion of out-patient occupational therapy treatment in the rehabilitation centers the participants will be randomly assigned into two groups: The treatment group will receive the intervention program in addition to standard care, and the waitlist control group will receive standard care only. Outcome measures: 1. The Canadian Occupational Performance Measure (COPM) 2. The Performance Quality Rating Scale (PQRS) 3. Mayo-Portland Adaptability Inventory (MPAI-4) 4. The Dysexecutive Questionnaire (DEX) 5. The New General Self-Efficacy Scale (NGSE) 6. The Zarit Caregiver Burden Scale short version Procedure: The intervention program includes up to 20 video sessions over 3 months between an occupational therapist and the participant. The virtual meetings will be conducted using The Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on problem solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities. Participants will be evaluated at baseline, after the intervention, and after 6 months.