Clinical trials: Brain Injury, Coma
Caregiver Distress, Emotional Distress
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.
- Conditions
- Caregiver Distress, Emotional Distress, Caregivers, Resilience
- Trial name
- COMA-F (NCT07331324)
- Testing
- Coma Family Program 1, Coma Family Program 2
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- Massachusetts General Hospital
Disorder of Consciousness, Traumatic Brain Injury
Validity and Feasibility of the CRSR-FAST
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings.
- Trial name
- CRSR-FAST (NCT03549572)
- Testing
- Coma Recovery Scale-Revised
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Massachusetts General Hospital
Disorder Related to Lung Transplantation, Brain Death
Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation
The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.
- Conditions
- Disorder Related to Lung Transplantation, Brain Death, Graft Failure, Primary Graft Dysfunction
- Trial name
- EVLP_MI (NCT01967953)
- Testing
- EVLP Group
- Where
- Italy
- Volunteers
- 7 people
- Sponsor
- Policlinico Hospital
Disorder of Consciousness
Information of the Coma Recovery Scale-Revised for Neurobehavioral State and Recovery of Consciousness Prediction
Background: The Coma Recovery Scale-Revised (CRS-R) is the most recommended instrument to examine the neurobehavioral condition of individuals with disorders of consciousness (DOCs).
- Trial name
- CRS-R_Info (NCT05819177)
- Testing
- Rehabilitation program
- Where
- 2 sites in Spain
- Volunteers
- 171 people
- Sponsor
- Hospitales Nisa
Non-environmental Hypothermia, Cardiac Arrest
Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest.
- Trial name
- NCT01155622
- Testing
- Endovascular Cooling
- Where
- Spain
- Volunteers
- 36 people
- Sponsor
- Hospital Universitario La Paz
Minimally Conscious State, Vegetative State
Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R
This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).
- Trial name
- NCT03126929
- Testing
- Coma Recovery Scale-Revised and Glasgow Coma Scale
- Volunteers
- 169 people
- Sponsor
- Hangzhou Normal University
Disorder of Consciousness, Vegetative State
The Use of LIFUP in Chronic Disorders of Consciousness
When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State…
- Conditions
- Disorder of Consciousness, Vegetative State, Minimally Conscious State, Minimally Conscious State Plus
- Trial name
- NCT04921683
- Testing
- BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Casa Colina Hospital and Centers for Healthcare
Brain Injuries, Traumatic
Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale
In this study, it is aimed to determine the prognostic value of GCS-P and the GCS-P score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated.
- Trial name
- NCT05767502
- Testing
- GCS-Pupil score
- Where
- Turkey (Türkiye)
- Volunteers
- 199 people
- Sponsor
- Uludag University
Disorders of Consciousness
mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness
The goal of this clinical trial is to test how effective the mindBEAGLE device is in allowing people who are unconscious (due to a brain injury or other condition) to communicate using brain waves to answer Yes/No questions.
- Trial name
- NCT06426602
- Testing
- mindBEAGLE daily device use
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Amy Wagner
Coma
Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma
Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between…
- Trial name
- ACI-Coma (NCT01620957)
- Where
- France
- Volunteers
- 43 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Blood Pressure and Cerebral Blood Flow After Cardiac Arrest
Comatose patients that are admitted to an intensive care unit after out-of-hospital cardiac arrest (OCHA) have a high mortality, particularly due to hypoxic-ischemic neurologic injury.
- Trial name
- NCT05434910
- Testing
- Changes in mean arterial pressure
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Niels Damkjær Olesen
Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest
- Conditions
- Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma, Cardiac Arrest
- Trial name
- NCT03024021
- Testing
- Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Tepecik Training and Research Hospital
Brain Injury Traumatic Severe (Diagnosis), Coma
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries.
- Conditions
- Brain Injury Traumatic Severe (Diagnosis), Coma, Consciousness, Level Altered, Anoxic Brain Injury
- Trial name
- STIMPACT (NCT03814356)
- Testing
- Methylphenidate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
Irreversible Loss of Brain Function (ILBF)
Automated Screening for Clinically Ascertained Loss of Cerebral Functions
Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death).
- Trial name
- DETECT-IVE (NCT06293170)
- Testing
- DETECT, Conventional care
- Where
- Germany
- Volunteers
- 4,800 people
- Sponsor
- Technische Universität Dresden
Disorder of Consciousness, Traumatic Brain Injury
Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of…
- Conditions
- Disorder of Consciousness, Traumatic Brain Injury, Anoxic Brain Injury, Stroke
- Trial name
- Neurodoc (NCT04035655)
- Testing
- Coma Recovery Scale - revised, Electrophysiological recordings
- Where
- France
- Volunteers
- 66 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the…
- Trial name
- Post-coma DBS (NCT01718249)
- Testing
- Implantable neurostimulation system
- Where
- France
- Volunteers
- 5 people
- Sponsor
- University Hospital, Clermont-Ferrand
Anoxic-Ischemic Encephalopathy
Study for the Improvement of Long-Term Outcome Prediction in Patients in Coma After Cardiac Arrest
The primary objective of HOPE is to improve the accuracy of outcome prediction in anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some of the existing methods used for this purpose (e.g.
- Trial name
- HOPE (NCT02231060)
- Where
- 16 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Ludwig-Maximilians - University of Munich
Disorders of Consciousness, Severe Brain Injury
Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.
The purpose of this study is to characterize and improve pain and nociception management in patients with disorders of consciousness (DOC).
- Conditions
- Disorders of Consciousness, Severe Brain Injury, Post-comatose Non-communicative Patients, Vegetative State
- Trial name
- NCT04330547
- Testing
- Analgesic administration
- Where
- Belgium
- Volunteers
- 19 people
- Sponsor
- University of Liege
Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI)
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).
- Conditions
- Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI), Subarachnoid Hemorrhage, Aneurysmal
- Trial name
- MCTs and ABI (NCT02716532)
- Testing
- Peptamen AF
- Where
- Switzerland
- Volunteers
- 17 people
- Sponsor
- Société des Produits Nestlé (SPN)
Intracranial Hypertension, Traumatic Brain Injury
Invasive Versus Non-Invasive Intracranial Pressure-Guided Management in Neurosurgical Patients
Raised intracranial pressure (pressure inside the skull) is a serious complication for patients with brain injuries, strokes, or tumors. Managing this pressure is critical to prevent further brain damage.
- Conditions
- Intracranial Hypertension, Traumatic Brain Injury, Subarachnoid Haemorrhage (SAH), Intracerebral Haemorrhage
- Trial name
- NCT07853963
- Testing
- External Ventricular Drain (EVD) Placement and ICP Monitoring, Optic Nerve Sheath Diameter (ONSD) Ultrasonography
- Where
- Nepal
- Volunteers
- 40 people
- Sponsor
- Kathmandu Medical College and Teaching Hospital