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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05206760 Completed - Clinical trials for Brain Injury Traumatic Severe

Severe Head Injury Brain Analysis

SHIBA
Start date: July 15, 2020
Phase:
Study type: Observational

Safety and feasibility study investigating brain biopsy in severe head injury. When a patient undergoes craniotomy or ICP bolt insertion for trauma, a biopsy of brain tissue is taken. Blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy. CSF is collected if a CSF drainage device is used.

NCT ID: NCT05195996 Completed - Trauma, Brain Clinical Trials

Beta Blocker Effects in Traumatic Brain Injury

Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.

NCT ID: NCT05189561 Completed - Clinical trials for Traumatic Brain Injury

Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

Start date: August 24, 2021
Phase: N/A
Study type: Interventional

Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. Detecting the underlying pathology is a major challenge especially for surgical cases. The outcome differs if the early intervention is performed. Near-infrared spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the replacement of a CT scan but can help in triage. This is a large-scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan finding.

NCT ID: NCT05183087 Completed - Clinical trials for Traumatic Brain Injury

Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Members

ReBlast
Start date: July 1, 2021
Phase:
Study type: Observational

This is a pilot study to identify biomarkers that individually, and in combination, demonstrate the greatest sensitivity to repetitive, low-level blast exposure (RLLBE) neurotrauma in Special Operations Forces (SOF) personnel. The proposed cross-sectional, multimodal study will elucidate the potential effects of long-term RLLBE by comparing biomarkers across subjects.

NCT ID: NCT05179330 Completed - Brain Injuries Clinical Trials

Visual Feedback in Lower Limb Rehabilitation

Start date: October 13, 2020
Phase: N/A
Study type: Interventional

Severe Acquired Brain Injury (sABI) is defined as "an encephalic impairment that occurs after birth and is not related to a congenital or degenerative disease. This impairment may be temporary, or permanent, and cause partial or functional disability or psychosocial distress." In Italy there are at least 10-15 new cases of sABI per year per 100,000 inhabitants; the estimated prevalence is about 150,000 cases per year. Often, people with sABI present focal neurological deficits, including alterations in strength, sensitivity, coordination and gait. Most of the rehabilitation protocols for people with sABI are derived from post-stroke studies, caused by lack of evidence on specific rehabilitation of people with sABI. Rehabilitation of people with sABI should begin as soon as possible, to prevent the onset of retractions and decubitus, and to regain joint mobility, strength, and coordination. OMEGO® (Tyromotion) is a newly developed device used in lower extremity rehabilitation, that provides visual and auditory feedback. Specifically, OMEGO® contains several games developed to enhance and promote learning behaviors, that simulate activities of daily living. The use of devices such as cycle ergometers is recommended in the rehabilitation of people with sABI; however, there are no studies demonstrating the effect of cycle ergometer training in association with visual feedback. The purpose of this study is to evaluate, both in people without apparent pathology (hereafter identified as "healthy") and in people with sABI, whether visual feedback during OMEGO® exercise modifies brain connectivity, emotional drive, and lower limb performance during a lower limb-specific motor rehabilitation task.

NCT ID: NCT05171010 Completed - Clinical trials for Traumatic Brain Injury

Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury

Start date: November 29, 2017
Phase:
Study type: Observational

This multicenter prospective observational study is designed to prospectively record data on patients who are managed per institutional standard of care. The objectives of this study are to establish an aggregate database of information on baseline clinical and demographic characteristics, medication use, markers of frailty, injury characteristics, management strategies, and outcomes following TBI in geriatric patients, determine best practices for management of geriatric patients with TBI, and establish how markers of frailty correlate with outcome in geriatric patients with TBI.

NCT ID: NCT05160194 Completed - Clinical trials for Traumatic Brain Injury

Gaining Real-Life Skills Over the Web

GROW
Start date: September 30, 2017
Phase: N/A
Study type: Interventional

Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries. GROW is designed to promote family and child coping and adjustment for caregivers.

NCT ID: NCT05155800 Completed - Clinical trials for Traumatic Brain Injury

A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

Sense-005
Start date: December 28, 2021
Phase:
Study type: Observational

The study population will consist of 3 mutually-exclusive sets of patients and subjects: - TBI patients with intracranial bleeding - TBI patients without intracranial bleeding - Control subjects with normal brain health. Research subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.

NCT ID: NCT05138692 Completed - Biomarkers Clinical Trials

Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury

Start date: October 1, 2000
Phase:
Study type: Observational [Patient Registry]

After written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (NICU) at Sahlgrenska university hospital, Gothenburg. Blood and CSF samples were collected during the initial 3 weeks after trauma. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels. 10-15 years after trauma a repeated evaluation according to GOS was performed by telephone. Different biomarkers such as Neurofilament light, Glial fibrillary acidic protein and Tau among others, was analyzed from serum and CSF samples. Further patients were explored Apolipoprotein-E genetype (APOE). The investigators hypothesize that higher biomarkers concentrations and positive test for this gene relate to worse outcome 1-year and 10-15 years after trauma. Further that these biomarkers and genetic marker further have prognostic value on outcome 1-year and 10-15 years after trauma. Finally, the investigators want to explore the concentrations dynamics of these biomarkers in serum and CSF in the acute phase after trauma.

NCT ID: NCT05097222 Completed - Clinical trials for Mild Traumatic Brain Injury

Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome

Start date: January 27, 2022
Phase: N/A
Study type: Interventional

Photobiomodulation therapy (PBMT) uses light to influence the mitochondria of cells. PBMT of the brain enhances the metabolic capacity of neurons and stimulates anti-inflammatory, anti-apoptotic, and antioxidant responses, as well as neurogenesis and synaptogenesis. Its therapeutic role in disorders such as dementia and Parkinson's disease, as well as to treat stroke, brain trauma, and depression has gained increasing interest. BioFlex is a form of PBMT consisting of light-emitting diodes (LEDs) and laser diodes. BioFlex utilizes red and near infrared light which penetrates tissues up to a certain tissue depth and studies have shown stimulates tissue growth and repair at the cellular level. PBMT has been proven useful for the treatment of soft tissue pain. Several studies have shown benefit in using PBMT in the treatment of certain neurological conditions, including chronic, mild traumatic brain injury (mTBI). The purpose of this exploratory investigation, therefore, is to examine efficacy of BioFlex laser therapy on measures of brain function in patients suffering from PCS after mild-moderate, closed-head, traumatic brain injury cases.