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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05823766 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)

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 and post-traumatic epilepsy (PTE) by extending follow-up of a previously enrolled cohort (TRACK-TBI) beyond the first 12 months after injury.

NCT ID: NCT05823168 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Seizures and Traumatic Brain Injury Rehabilitation

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

post-traumatic seizures (PTS) are a common and debilitating complication of traumatic brain injury (TBI) and could have harmful impact on patient disabilty and rehabilitation outcome. In this multicentric prospective observational study we aimed to evaluate the role on functional outcome of patients admitted to neurorehabilitation unit afther traumatic brain injury of: - newly occurring seizures - prescription of antiepileptic prophylactic therapy The inclusion criteria were the following: 1) age ≥ 18; 2) diagnosis of TBI on presentation; 3) admission to a hospital emergency department within 24 h of injury; 4) admission within one month from the injury to the rehabilitation unit to continue clinical care and rehabilitation program; 5) up to 6 months of observation in rehabilitation setting. Were collected the following variables: gender, medical history, age at occurrence of injury, injury characteristics, fracture site, presence of penetrating TBI, presence of subarachnoid haemorrhage, associated neurosurgical procedures (craniotomy, cranioplasty), neurologic and functional assessments, brain imaging, occurrence of seizure, presence and type of anticonvulsant therapy, death during hospitalization. The investigator analysed through logistic regression variables predictors of risk occurrence of seizure, and neurological and functional outcome, respectively assessed with the Glasgow Coma Scale (GCS) and the Functional Independence Measure (FIM).

NCT ID: NCT05819008 Recruiting - Stroke Clinical Trials

Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries

Start date: March 10, 2023
Phase:
Study type: Observational

For the last decades, many aspects of human life have been altered by digital technology. For health care, this have opened a possibility for patients who have difficulties travelling a long distance to a hospital to meet with their health care providers over different digital platforms. With an increased digital literacy, and an aging population often living in the countryside, far from hospitals or other health care settings, an increasing need for digitalization of meetings between patients and health care personnel is inevitable. However, neuropsychological assessment is one sort of health care not possible to directly transfer into digital form. These evaluations are most often performed with well validated tests, only to be used in a paper-pencil form with a specially trained psychologist during physical meetings. The aim of this project is to investigate whether a newly developed digital neuropsychological test battery can be used to perform remote assessments of cognitive function in patients with neurological injuries and impairments. To this date, there are no such test batteries available in the Swedish language. Mindmore (www.mindmore.com) is a test system developed in Sweden, performing neuropsychological tests on a tablet, but still with the psychologist present in the room. This system is now evolving into offering the possibility for the patient to perform the test in their own home, using their own computer or tablet. The aim of the present research project is to validate this latter system (Mindmore Distance), using the following research questions: 1. Are the tests in Mindmore Distance equivalent to traditional neuropsychological tests in patients with traumatic brain injury, stroke, multiple sclerosis, Parkinson's Disease, epilepsy, and brain tumor? 2. Can the results from Mindmore Distance be transferred into neuropsychological profiles that can be used in diagnostics for specific patient groups? 3. How do the patients experience undergoing a neuropsychological evaluation on their own compared to traditional neuropsychological assessment in a physical meeting with a psychologist?

NCT ID: NCT05818371 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage

Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting

ONSDDynamics
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.

NCT ID: NCT05809401 Recruiting - Stroke Clinical Trials

Pragmatic Assessment and Treatment for the Health System

PATHS
Start date: November 13, 2019
Phase: N/A
Study type: Interventional

The project goal is to promote a feasible and effective approach to communicative disorders in neurological and psychiatric populations, focused on the pragmatics of language. Pragmatics allows speakers to use and interpret language in context and to engage in successful communication. Pragmatic language disorder is widespread in clinical conditions and causes reduced social interactions and lower quality of life for both patients and their family. Yet it is seldom considered in assessment and rehabilitation.

NCT ID: NCT05807503 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury

Start date: February 1, 2020
Phase:
Study type: Observational

Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.

NCT ID: NCT05793827 Recruiting - Stroke Clinical Trials

Pilot Trial for Adults With Acquired Brain Injury

RCT
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

This pilot study will compare a yoga program to a non-yoga exercise program in adults with brain injuries. The investigators will measure possible improvements in balance and heartrate. The investigators also plan to measure changes in brain function and link balance and/or heartrate improvements to changes in brain function. Ideally, this work will create a foundation for a larger-scale study.

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: NCT05782244 Recruiting - Clinical trials for Traumatic Brain Injury

Sildenafil for Microvasculopathy in Chronic TBI

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ameliorate the consequences of TBI. Sildenafil potentiates nitric oxide (NO) dependent vasodilatation and is approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction and primary pulmonary hypertension. In pre-clinical models of stroke, sildenafil improves cerebral blood flow (CBF), promotes, angiogenesis, neurogenesis and improves recovery. In an initial Phase 2a trial (NCT01762475) of sildenafil in patients with chronic moderate to severe TBI, the investigators found that low dose sildenafil (25 mg BID) therapy is safe and well tolerated, that a single dose of sildenafil 50 mg potentiates CVR in areas of the brain with dysfunctional endothelium, and that CVR is a reliable diagnostic marker of TCVI and has potential as a pharmacodynamic and predictive biomarker. In this proposal, the investigators will conduct a randomized clinical trial to determine the optimal PDE5 inhibitor dose to improve or normalize microvascular function (as measured by the change in CVR measurements before and after a single dose of sildenafil, or ΔCVR) using a range of sildenafil citrate doses: 20, 40, 80 mg) in chronic TBI patients. The investigators will also test the safety and tolerability of the same dose ranges of chronic (4-week) thrice daily sildenafil or placebo administration in chronic TBI patients and explore its effects on chronic symptoms and clinical outcomes.