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Brain Injuries clinical trials

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NCT ID: NCT05965947 Recruiting - Brain Injuries Clinical Trials

The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury

HOME
Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

Brain injury is a leading cause of disability in the United States. When survivors of brain injury recover from the initial injury and return home to live in the community, they often face chronic health conditions that warrant nutrition therapy, such as diabetes, high blood pressure, high cholesterol, and overweight and obesity. Typically, these individuals do not receive nutrition counseling. Thus, the purpose of this clinical trial is to compare changes in diet quality between community-dwelling individuals with a history of brain injury who receive three individualized nutrition therapy sessions versus handouts only. Our research question is: Can nutrition counseling improve dietary intake among this population? Participants will complete a survey, participate in three days of dietary recalls via Zoom or telephone, and receive either three individualized nutrition counseling sessions with a Registered Dietitian or standard of care (handouts). Researchers will compare the diets of the recipients of the nutrition counseling to a control group who receives nutrition handouts to see if nutrition sessions with a Registered Dietitian improve dietary intake.

NCT ID: NCT05964764 Recruiting - Clinical trials for Brain Injuries, Traumatic

Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

SHIPP
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed. The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department. The main research question is: - Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes? Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group. The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).

NCT ID: NCT05951985 Recruiting - Stroke Clinical Trials

High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners

SHIFT-AR
Start date: August 15, 2023
Phase: N/A
Study type: Interventional

Individuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.

NCT ID: NCT05951777 Recruiting - Clinical trials for Traumatic Brain Injury

Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Start date: April 16, 2024
Phase: Phase 2
Study type: Interventional

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury and/or hypoxic-ischemic encephalopathy in adults.

NCT ID: NCT05943756 Recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Evaluation of Well-being Interventions in Adults With TBI

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.

NCT ID: NCT05934773 Recruiting - Stroke Clinical Trials

Post-Brain Injury Walking and Balance Recovery Program

Start date: August 18, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to test the efficacy of a walking and balance training program designed to safely challenge and improve walking performance and balance in relation to walking speed, strength, endurance, and balance after traumatic brain injury (TBI). The aim and primary hypothesis of this research project is: Aim) Test and implement a new personalized intervention strategy, in addition to usual and customary care at an inpatient rehabilitation clinic, to improve patient outcomes with secondary conditions associated with impaired balance and walking that typically occur post brain injury. After validation of the locomotor Battery of tests, we will implement a personalized training strategy for individuals based on their battery profile. Hypothesis) Individuals training with this individualized protocol will demonstrate improved walking and balance outcomes and those with lesser pre-intervention impairment will improve at a greater rate than those with greater pre-intervention impairment.

NCT ID: NCT05933629 Recruiting - Clinical trials for Traumatic Brain Injury

Community-based Implementation of Online EmReg

Start date: July 18, 2023
Phase: N/A
Study type: Interventional

This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation trial. Consistent with best practices for this type of design, the study team will conduct a randomized test of the effect of implementation strategy on effective delivery of the Online EmReg intervention in clinical practice. Specifically, the study team will compare Standard Training (a 3-hour on-demand training workshop) to Extended Training, (a 3-hour on-demand training workshop with 3 months of bi-weekly consultation). The research team's primary aim is to determine the optimal strategy to train clinicians in effectively delivering Online EmReg, and secondary aim is to assess patient improvement per clinician-administered DERS. Outcome measures will be assessed via self-report surveys, performance evaluations (via role-plays), and tracked clinician participation and fidelity. Study participation is expected to last up to 15 months.

NCT ID: NCT05931250 Recruiting - Cerebral Injury Clinical Trials

Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Start date: June 16, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical intervention is to test if two forms of transcranial current stimulation, transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS) can alleviate neuropathic eye pain in a sample of 20 patients. The main aims are: - Test if tDCS/tACS can alleviate neuropathic eye pain and/or other cerebral symptoms: brain fatigue, migraine, light sensitivity, etc. - Test if one stimulation method is superior to the other Patients will be treated for a total of fifteen 30-minute stimulation sessions, three times a day over a five-day period, each stimulation separated by approximately 4 hours, with either active tACS or tDCS over the scalp corresponding to primary sensory and motor areas. The patients will have questionnaires to monitor subjective experiences and pupillometry before and after treatment to monitor experimental outcomes.

NCT ID: NCT05922748 Recruiting - Cerebral Lesion Clinical Trials

Brain Injury and Cognitive Function

Start date: February 5, 2014
Phase: N/A
Study type: Interventional

The objective of this exploratory study is to elucidate the underlying cerebral mechanisms of cognitive deficits. To achieve this, the investigator will apply functional brain imaging techniques to patients suffering from cognitive deficits due to cerebral lesions. The investigator will employ a "single-case" approach, suitable for studying rare behavioral profiles such as acquired reading disorders (alexia) or visual perception impairments (agnosia). If necessary, the investigator will use multiple non-invasive imaging methods in the same patients, including: 1. Magnetic Resonance Imaging (structural and functional), renowned for its spatial resolution and the diverse information it provides, and 2. Electrophysiological methods (MEG and EEG), notable for their temporal resolution. The employed stimuli will consist of visual or auditory presentations of verbal material (words, sentences, numbers, etc.), potentially combined with the collection of simple vocal or motor responses (button presses). The results will be interpreted by integrating the neuropsychological analysis of the deficit and the lesion topography. Importantly, following the methodology of single-case neuropsychology, the stimulation protocols will be modulated and adapted to each individual case. Consequently, parallel data should be collected from healthy control subjects whenever necessary. For protocol development, the investigator will also collect purely behavioral data, without brain imaging, from groups of control subjects.

NCT ID: NCT05916417 Recruiting - Clinical trials for Traumatic Brain Injury

TMS-fNIRS Personalized Dosing

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS. Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)