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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT06083792 Not yet recruiting - Clinical trials for Traumatic Brain Injury

ICP Threshold After Decompressive Craniectomy

Start date: October 8, 2023
Phase:
Study type: Observational

Severe traumatic brain injury (sTBI) is a critical disease of public health importance. Increased intracranial play a significant role in the secondary injury of TBI. Reducing the ICP is helpful in reducing the mortality of sTBI. The threshold of ICP for sTBI has been suggested. The threshold of ICP for sTBI after decompressive craniectomy is not clear.

NCT ID: NCT06083441 Recruiting - Clinical trials for Traumatic Brain Injury

SeeMe: An Automated Tool to Detect Early Recovery After Brain Injury

Start date: June 16, 2019
Phase:
Study type: Observational

Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, "SeeMe," to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.

NCT ID: NCT06081283 Recruiting - Stroke Clinical Trials

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Start date: November 20, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are: - Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population? - What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity? Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

NCT ID: NCT06080269 Recruiting - Clinical trials for Traumatic Brain Injury

To Compare the Effect of Receiving the Technology-based Training Along With the Conventional Therapy to the Conventional Therapy Alone on Executive Functions Among People With Traumatic Brain Injury With Mild to Moderate Cognitive Deficit

Start date: May 25, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effect of receiving the technology-based training along with the conventional therapy to the conventional therapy alone on executive functions among people with traumatic brain injury with mild to moderate cognitive deficit. It aims to answer: - If there is significant improvement in executive function skills among people with traumatic brain injury receiving technology-based training along with conventional therapy when compared to people with traumatic brain injury receiving conventional therapy alone. - To see if the demographic variable has any effect on the cognitive improvement Participants will in the intervention group will be given 45 minutes of extra training session using technology along with their usual rehabilitation session. And Participants in the control group will be receiving the usual rehabilitation sessions. Researchers will compare the changes in the outcome measures between the intervention and control group to see if the technology-based training along with conventional therapy had significant effect on executive skills among people with traumatic brain injury.

NCT ID: NCT06074328 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study

BRIGHT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is a major public health concern, particularly among older adults (OAs) ≥ 65 years of age. Each year in the United States, TBI results in over 600,000 emergency department visits and hospitalizations among OAs. Mild TBI (mTBI) accounts for 80% of all TBI in OAs and is quite understudied in this rapidly growing population. mTBI, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. Cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following TBI. Virtual reality (VR) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (NRM) to improve cognitive decline post TBI. Not only can VR provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. Yet, despite the promise of cognitive rehabilitation using VR among OAs, very few studies to date have assessed the efficacy of VR cognitive rehabilitation in TBI. The aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in OAs with mTBI. The hypothesis is that The use of VR mediated cognitive exercises post mTBI will be associated with improved executive function at 6-weeks post-randomization compared to the control group.

NCT ID: NCT06073886 Not yet recruiting - Depression Clinical Trials

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Start date: January 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.

NCT ID: NCT06073106 Not yet recruiting - Breast Cancer Clinical Trials

Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

OPTIMA-C
Start date: December 2023
Phase:
Study type: Observational

The aging population and its accompanying burden from non-communicable chronic diseases predicts an increasing impact imposed by frailty on healthcare systems. This is due to a lack of normative data for older adults and reliable risk stratification methods to develop effective approaches to the prevention of frailty. In this study, the investigators plan to form a common dataset for phenotype identification, risk stratification of frailty and its targeted treatment plans in the at-risk and mildly frail population.

NCT ID: NCT06072001 Recruiting - Stroke Clinical Trials

Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to central neuropathy of any genesis. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to central neuropathy of any genesis.

NCT ID: NCT06071949 Recruiting - Stroke Clinical Trials

Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to central neuropathy of any genesis. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to central neuropathy of any genesis.

NCT ID: NCT06070025 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health

Start date: January 22, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are: - Establish individual mental and physical performance profile and brain health baseline in Infantry Marines - Develop predictive models to identify early signs of mental and/or physical degradation that can help predict "red-line" behavioral events and degradation in brain health. - Gather insights that will lead to developing personalized, evidence-based interventions to restore mental and physical performance. - Increase warfighter self-knowledge and personal awareness to monitor and maximize performance. Participants will wear wear smart watches and analyte sensors to track their real time physiological and sleep measures and complete subjective and psychological measures in a custom research app.