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Brain Injuries clinical trials

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NCT ID: NCT06467708 Not yet recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

tAN-TBI
Start date: July 2024
Phase: N/A
Study type: Interventional

The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.

NCT ID: NCT06465290 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Promoting Neuroplastic Changes of Patients With TBI

Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

NCT ID: NCT06464549 Not yet recruiting - Clinical trials for Acquired Brain Injury

Spontaneous Eye Blinking Evaluation for Cognitive Assessment of Individuals With Severe Acquired Brain Injury

SEE-ABI
Start date: June 25, 2024
Phase:
Study type: Observational

Assessment of consciousness and attention in individuals with severe Acquired Brain Injury (sABI) is crucial for planning rehabilitation, but it is often hindered by coexisting sensory-motor and/or cognitive-behavioural disorders. This project aims at evaluating the value of spontaneous eye blinking features to assess patients' attentional abilities and to distinguish patients with unresponsive wakefulness syndrome (UWS) from those in minimally conscious state (MCS). Patients will undergo an EEG-EOG recording at rest and during an auditory oddball task. Eye blinking features on EOG will be analysed and compared to that of healthy individuals. A machine-learning-based algorithm using blinking features for the diagnosis of patients with sABI will be studied and validated preliminarily. This project will help to stratify patients with sABI using easy-to-detect clinical markers, supporting clinicians' decision-making about patient's management. Additionally, blinking patterns related to residual attentional abilities in patients emerged from disorders of consciousness will be investigated.

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: NCT06429007 Not yet recruiting - Infant Development Clinical Trials

A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

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

Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.