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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT06454591 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Rapid MRI for Assessing Functional Abilities and Predicting TBI Outcomes

Start date: August 2024
Phase:
Study type: Observational

Our project aims to develop a rapidly acquired and communicated MRI assessment and report that incorporates functional and structural imaging to convey information about functional neurological insults following traumatic brain injury (TBI) that are not typically visible on clinical imaging. Within this framework, there are two sub-studies. The first is a prospective study of patients with TBI who will have an MRI in the sub-acute period after their injury, followed by clinical assessments up to 90 days post-injury. A model will be developed to link MRI biomarkers to persistent symptoms of TBI. The second sub-study will use a focus group methodology to develop the report content and format with input from several groups of stakeholders.

NCT ID: NCT06453733 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Crainio Non-invasive ICP Monitor for TBI

Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring. This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury. The primary objective is to establish the diagnostic accuracy of the Crainio device, aiming for at least 90% sensitivity and specificity in detecting raised ICP (above 20 mmHg). Secondary objectives include evaluating patient-related factors such as skin tone, skull thickness, and skull density, as well as the tolerability and acceptance of the device by both patients and healthcare professionals.

NCT ID: NCT06445595 Not yet recruiting - Clinical trials for Traumatic Brain Injury

The Relationship Between Obesity and Chronic Headache

Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.

NCT ID: NCT06431139 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury

INSPIRE
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The aim of this randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. For the trial to be feasible, all outcomes must be achieved. The primary hypothesis is that it is feasible to progressively increase the number of repetitions of sit-to-stand exercises in patients with moderate to severe traumatic brain injury admitted to a rehabilitation department during the intervention period. Furthermore, the investigators hypothesize that the increased number of repetitions will increase the participant's functional capabilities regarding sit-to-stand and walking, decrease resting heart rate, blood pressure, and metabolism, reduce inflammatory and brain injury biomarkers, and improve the cognitive performance.

NCT ID: NCT06429774 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Comparative Effectiveness of Intervention in Multi-level Hospitals for Acute Traumatic Brain Injury(Metric-TBI)

Start date: July 1, 2024
Phase:
Study type: Observational [Patient Registry]

A prospective, multicenter, observational cohort study is designed to compare the effectiveness of intervention in multi-grade hospitals for acute traumatic brain injury and to optimize clinical outcomes.

NCT ID: NCT06429657 Not yet recruiting - Clinical trials for Intracranial Hypertension

Ketamine for Sedation in Severe Traumatic Brain Injury

Ketamine
Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.

NCT ID: NCT06413173 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

NCT ID: NCT06391203 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Drilling or puncture drainage is commonly used in TBI patients with subdural effusion following decompressive craniectomy who fail to respond to conservative treatment, but there is no exact regulation or guideline recommendation for the drainage time. The investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term versus short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury.

NCT ID: NCT06381674 Not yet recruiting - Rehabilitation Clinical Trials

Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation

SuBTyPE
Start date: May 13, 2024
Phase: N/A
Study type: Interventional

Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.

NCT ID: NCT06380985 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury

TABM
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.