Clinical trials: Severe Brain Injury
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
Traumatic Brain Injury, Cerebral Edema
Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury
The purpose of this study is to investigate the clinical improvement measured by the Glasgow Outcome Scale Extended (GOS-E) with ABX-101 compared with Placebo intramuscular injection in participants with moderate to severe TBI.
- Trial name
- NCT06096415
- Testing
- ABX-101 1mg, ABX-101 2mg
- Volunteers
- 45 people
- Sponsor
- Abalonex, LLC
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.
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.
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.
Neurologic Disorder, Paralysis
COMMAND 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
- NCT05035823
- Testing
- Motor Neuroprosthesis (MNP)
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Synchron Medical, Inc.
Traumatic Brain Injury
Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury
This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome in patients with moderate and severe traumatic brain injury.
- Trial name
- NOSTRA-III (NCT02794168)
- Testing
- VAS203, Saline
- Where
- 29 sites in Austria, France and 3 more
- Volunteers
- 224 people
- Sponsor
- veriNOS operations GmbH
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
Intracranial Hypertension
Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external…
- Trial name
- NCT02695264
- Testing
- HS-1000 recording
- Where
- United States
- Sponsor
- HeadSense Medical
Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic
A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)
The purpose of the study is to evaluate the enzyme activity and safety of pancrelipase in patients with severe Exocrine Pancreatic Insufficiency (EPI)
- Conditions
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic, Steatorrhea, Pancreatitis
- Trial name
- NCT00676702
- Testing
- Ensure Plus, Pancrelipase in combination with Ensure Plus
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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
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.
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)
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 22 sites in United States
- Volunteers
- 173 people
- Sponsor
- ReAlta Life Sciences, 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.
Terminal Illness, End-of-Life Care
Non-Invasive Detection and Preservation of Neurocognitive Signals in the Peri-Death Period Using Brain-Computer Interface and Artificial Intelligence
Background: Recent electroencephalography (EEG) data indicate that the transition from clinical death to cellular death is marked by highly organized neurophysiological events, including significant surges in gamma-band power…
- Conditions
- Terminal Illness, End-of-Life Care, Death, Brain Death
- Trial name
- NeuroCogPresv (NCT07477028)
- Volunteers
- 20 people
- Sponsor
- Noah Tech, Corp.
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