Clinical trials: Brain Trauma
Concussion, Mild
Pro-2-Cool Pivotal Trial II
This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by…
- Trial name
- NCT06929923
- Testing
- Pro2Cool Device
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- TecTraum Inc.
Brain Injuries, Traumatic, Concussion, Mild
Objective Brain Function Assessment of mTBI/Concussion
This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the…
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- CAS13-25 (NCT03963804)
- Testing
- BrainScope Ahead 300iP
- Where
- 4 sites in United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Traumatic Subarachnoid Haemorrhage
Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage
Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries.
- Trial name
- NCT02073890
- Volunteers
- 117 people
- Sponsor
- Macmillan Research Group UK
Traumatic Brain Injury
Normothermia Protocol for Traumatic Brain Injury Patients
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury…
- Trial name
- NCT01354509
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medivance, Inc.
Traumatic Brain Injury
EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY
The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent…
- Trial name
- ALERT-TBIx (NCT02439736)
- Testing
- Blood draw within 12 hours of head injury
- Where
- 7 sites in United States, Germany
- Volunteers
- 119 people
- Sponsor
- Banyan Biomarkers, Inc
Brain Injuries, Intracranial Hypertension
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical…
- Trial name
- NCT02772471
- Testing
- HS-1000
- Where
- Norway
- Volunteers
- 40 people
- Sponsor
- HeadSense Medical
Spasticity
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total…
- Trial name
- LANTIMA (NCT04752774)
- Testing
- Corabotase, Dysport
- Where
- 81 sites in United States, Austria and 12 more
- Volunteers
- 240 people
- Sponsor
- Ipsen
Chronic Subdural Hematoma, cSDH
Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain.
- Conditions
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- Trial name
- iCURE cSDH (NCT07214623)
- Testing
- Neuro endovascular embolic coil
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Kaneka Medical America LLC
Mild Traumatic Brain Injury, Concussion
A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury
This is a Phase IIa, randomized, double-blind, placebo-controlled pilot study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ONP-002 in adults with mild traumatic brain injury (mTBI).
- Trial name
- NCT06870240
- Testing
- Neurosteroid enantiomer
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Oragenics, Inc.
Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS)
PRISM Registry: Pseudobulbar Affect Registry Series
PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary…
- Conditions
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease
- Trial name
- NCT01366027
- Where
- United States
- Volunteers
- 5,290 people
- Sponsor
- Avanir Pharmaceuticals
Traumatic Brain Injury (TBI), Acquired Brain Injury
LearningRx Cognitive Training for Brain Injury
The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, daily functioning, and workplace self-efficacy for participants with Traumatic Brain…
- Conditions
- Traumatic Brain Injury (TBI), Acquired Brain Injury, Post COVID-19 Cognitive Impairment
- Trial name
- NCT02918994
- Testing
- LearningRx cognitive training
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Gibson Institute of Cognitive Research
Cerebral Palsy, Acquired Brain Injury
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
- Conditions
- Cerebral Palsy, Acquired Brain Injury, Spinal Muscular Atrophy
- Trial name
- NCT06167954
- Testing
- EXPLORER
- Where
- 5 sites in Spain
- Volunteers
- 50 people
- Sponsor
- MarsiBionics
Cranial Waveform in Normal Patients as a Result of Cardiac Cycle, Healthy
500 "Normal" Adult Subjects Who Have Experienced no Known Brain Injury Will Participate in Collecting Data That Will Assist With the Optimization of the Diagnostic Capabilities of the Harmony in Detecting Neurologic Abnormalities.
The REFRESH study is designed to collect data related to a signal in the brain that MindRhythm has named the Headpulse. The Headpulse occurs as a natural movement of the brain in conjunction with the beating of the heart.
- Trial name
- REFRESH (NCT05203393)
- Testing
- Harmony Headset
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- MindRhythm, Inc.
Traumatic Subdural Hematoma
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly.
- Trial name
- NCT03878043
- Testing
- Follow-up Care
- Where
- United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Tarik Wasfie, MD
TBI (Traumatic Brain Injury), Concussion, Brain
Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC)…
- Conditions
- TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury, Closed Head Injury
- Trial name
- MEDO (NCT04279431)
- Testing
- EEG Recording, Neurocognitive Tests, Clinician Evaluation
- Where
- 7 sites in United States
- Volunteers
- 660 people
- Sponsor
- BrainScope Company, Inc.
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
Subdural Hematoma
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma…
- Trial name
- EMBOLISE (NCT04402632)
- Testing
- Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization, Observation Only
- Where
- 49 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Mild Traumatic Brain Injury, Intracranial Lesions
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are…
- Conditions
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- Trial name
- TESCO (NCT07490418)
- Testing
- Temnographic Brain Screening Examination
- Where
- 3 sites in Italy, Poland
- Volunteers
- 850 people
- Sponsor
- B&B srl
Post Concussive Syndrome, Chronic, Post Concussion Symptoms
Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome
This study looks at the effects of accelerated intermittent theta burst stimulation (aiTBS) on patients with chronic and acute post-concussion syndrome.
- Conditions
- Post Concussive Syndrome, Chronic, Post Concussion Symptoms, Post Concussive Syndrome, Post Concussion Syndrome
- Trial name
- NCT07211919
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Cognitive FX
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