Clinical trials: Severe Brain Trauma
PTSD, Alzheimer Disease
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: What is the safety of single ascending doses of the…
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease
- Trial name
- NCT05921929
- Testing
- Fluoroethylnormemantine (FENM)
- Where
- Belgium
- Volunteers
- healthy volunteers welcome
- Sponsor
- ReST Therapeutics
Brain Injuries, Traumatic, Concussion, Mild
Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Severe
- Trial name
- CASVAL (NCT02957461)
- Testing
- BrainScope Ahead 200iD
- Where
- 8 sites in United States
- Volunteers
- 420 people
- Sponsor
- BrainScope Company, Inc.
Neurologic Disorder, Paralysis
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- NCT05041114
- Testing
- Motor Neuroprosthesis
- Where
- 3 sites in Australia
- Sponsor
- Synchron Medical, Inc.
Traumatic Brain Injury
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury…
- Trial name
- NCT04063215
- Testing
- HB-adMSCs
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Hope Biosciences LLC
Traumatic Encephalopathies, Chronic, Concussion, Mild
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental…
- Conditions
- Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- C-TBI (NCT02959294)
- Testing
- Microcannula Harvest Adipose, Centricyte 1000, Sterile Normal Saline IV deployment AD-cSVF
- Where
- United States
- Sponsor
- Robert W. Alexander, MD, FICS
Concussion, Mild, Concussion; Eye
EYE-SYNC Concussion Classification Study
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion…
- Conditions
- Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe
- Trial name
- NCT04381767
- Testing
- EYE-SYNC
- Where
- United States
- Volunteers
- 1,303 people
- Sponsor
- Sync-Think, Inc.
Traumatic Brain Injury
Dexanabinol in Severe Traumatic Brain Injury
Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death.
- Trial name
- NCT00129857
- Testing
- Dexanabinol
- Volunteers
- 860 people
- Sponsor
- Pharmos
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)
Major Depressive Disorder (MDD, Anxiety Disorder, Generalized
Serotonin Variants & Gut Microbiota in Mental Health
This observational pilot study investigates whether a broad panel of genetic variants relevant to the serotonin pathway (including serotonergic system, methylation cycle, intestinal barrier integrity, and inflammatory response…
- Conditions
- Major Depressive Disorder (MDD, Anxiety Disorder, Generalized, Stress Disorders, Post-Traumatic, Panic Disorder
- Trial name
- NCT07634458
- Testing
- SNP Genotyping and Gut Metagenomics
- Volunteers
- 30 people
- Sponsor
- Neurobiologix
Chronic Traumatic Brain Injury, TBI (Traumatic Brain Injury)
Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
The purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI)…
- Trial name
- NCT07730099
- Testing
- Deep brain stimulation
- Volunteers
- 40 people
- Sponsor
- ReEmerge, Inc.
Brain Injuries
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
- Trial name
- SyNAPSe (NCT01143064)
- Testing
- Progesterone, Lipid emulsion without progesterone
- Where
- 156 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- BHR Pharma, LLC
Traumatic Brain Injury
Copenhagen Head Injury Ciclosporin (CHIC) Study
This is an open label study on the pharmacokinetics and safety of ciclosporin in patients with severe traumatic brain injury, who require intensive care unit admission and monitoring of intracranial pressure via a ventricular…
- Trial name
- CHIC (NCT01825044)
- Testing
- NeuroSTAT 5 mg/kg/day, NeuroSTAT 10 mg/kg/day
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- NeuroVive Pharmaceutical AB
Brain Injuries, Traumatic, Concussion, Mild
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Severe, Concussion, Intermediate
- Trial name
- CAS13-25V (NCT03671083)
- Testing
- BrainScope Ahead 300iP
- Where
- 5 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Neurologic Disorder, Paralysis
EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis
Neuralis is an innovative assistive technology designed for individuals with severe neuromuscular conditions, enabling wheelchair control through EEG signals.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- NCT06169696
- Testing
- Intervention/Treatment
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Synaptrix Labs Inc.
Brain Concussion, Cerebral Concussion
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED)…
- Conditions
- Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild
- Trial name
- DETECT (NCT02776462)
- Testing
- EyeBox CNS
- Where
- 2 sites in United States
- Volunteers
- 321 people
- Sponsor
- Oculogica, Inc.
Traumatic Brain Injury
Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury
In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with moderate and severe traumatic brain injury.
- Trial name
- NOSTRA (NCT02012582)
- Testing
- VAS203, Saline
- Where
- 6 sites in Austria, France and 3 more
- Volunteers
- 32 people
- Sponsor
- veriNOS operations GmbH
Traumatic Brain Injury
A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.
A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V.
- Trial name
- NCT00735085
- Testing
- SLV334
- Where
- 14 sites in United States, Israel and 2 more
- Volunteers
- 57 people
- Sponsor
- Abbott Products
Traumatic Brain Injury
Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
The main goal of this clinical trial is to check if the treatment is safe and well-tolerated. Researchers will compare the MR-301 active drug group with the placebo group to evaluate the safety and tolerability of the drug.
- Trial name
- NCT06253923
- Testing
- Amantadine Hydrochloride
- Where
- 13 sites in United States
- Volunteers
- 45 people
- Sponsor
- SHINKEI Therapeutics, Inc
PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction
Trifecta Research Study
This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder…
- Conditions
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury, Depression - Major Depressive Disorder
- Trial name
- NCT07717866
- Testing
- Magnetic e-Resonance Therapy (MeRT), Ibogaine Hydrochloride with Magnesium Sulfate, 5-methoxy-N,N-dimethyltryptamine
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Axial Therapeutic Research
Traumatic Brain Injury
Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)
The primary objective of this study is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury (TBI).
- Trial name
- STOP-TBI (NCT00908063)
- Testing
- Oxycyte, Normal Saline
- Where
- 6 sites in Israel, Switzerland
- Volunteers
- 18 people
- Sponsor
- Tenax Therapeutics, Inc.