Clinical trials: Closed Head Trauma
Concussion, Intermediate
Unblinded Data Collection Study of Concussion Using BrainPulse
This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of injury.
- Trial name
- NCT02992795
- Testing
- BrainPulse
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.
Concussion, Brain, Mild Traumatic Brain Injury
EyeBOX Concussion Study and Registry
The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of…
- Trial name
- NCT03966404
- Testing
- EyeBOX device
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Oculogica, Inc.
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
Brain Concussion, Mild Traumatic Brain Injury
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm.
- Trial name
- NCT02812225
- Testing
- BrainPulse
- Where
- 3 sites in United States
- Volunteers
- 406 people
- Sponsor
- Jan Medical, Inc.
Concussion, Brain, Mild Traumatic Brain Injury
A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings.
- Trial name
- NCT05527041
- Testing
- EyeBOX Lens (EBLens)
- Where
- United States
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Oculogica, Inc.
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, 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.
Mild Traumatic Brain Injury
Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment…
- Trial name
- NCT05337774
- Testing
- [18F]PI-2620
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Life Molecular Imaging SA.
Severe Head Trauma
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8).
- Trial name
- ABELADRUG200 (NCT00810940)
- Testing
- AbelaDrug200, mannitol
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abela Pharmaceuticals, Inc.
Mild Traumatic Brain Injury
Pro-2-Cool Device Clinical Study
This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.
- Trial name
- NCT03511339
- Testing
- TecTraum device
- Where
- 5 sites in United States
- Volunteers
- 174 people
- Sponsor
- TecTraum Inc.
Mild Traumatic Brain Injury
Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm…
- Trial name
- NCT02849002
- Testing
- BrainPulse
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Jan Medical, Inc.
Motor Vehicle Accidents, TBI (Traumatic Brain Injury)
Concussion in Motor Vehicle Accidents: The Concussion Identification Index
The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment…
- Conditions
- Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion, Brain Injuries
- Trial name
- CIDI (NCT02858544)
- Testing
- The Concussion Identification Index, ImPACT
- Where
- United States
- Volunteers
- 1,790 people
- Sponsor
- Clionsky Neuro Systems Inc.
Post-Concussion Symptoms, Insomnia
Neurotechnology Following Traumatic Brain Injury
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI).
- Conditions
- Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
- Trial name
- Cereset (NCT03649958)
- Testing
- HIRREM-SOP or Cereset, Cereset 2x
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Brain State Technologies, LLC
Concussion, Brain
EEG-guided Cognitive Pacing Tool During Concussion Recovery
This investigation will assess the utility of a novel wearable electroencephalography (EEG) headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a…
- Trial name
- NCT05522855
- Testing
- EEG Sensorband and mobile application
- Volunteers
- 50 people
- Sponsor
- Dr. Matthew Kennedy
Brain Concussion, Brain Injuries
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis.
- Trial name
- NCT02699359
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical
Traumatic Brain Injury
TBI MR Study 3 Houston Methodist
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic…
- Trial name
- NCT02218216
- Testing
- MRI Diagnostic
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- GE Healthcare
MTBI - Mild Traumatic Brain Injury
Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury
The proposed study tests the efficacy (Phase II) of 36 or 54 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve working memory, processing speed and attention in mTBI patients rapidly…
- Trial name
- NCT03655782
- Testing
- PATH + DigitMemory (DM) neurotraining
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Perception Dynamics Institute
Mild Traumatic Brain Injury
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software…
- Trial name
- CogMind (NCT02922569)
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training, Mindfulness Training
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Posit Science Corporation
Mild Traumatic Brain Injury, Concussion, Binocular Visual Function
An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
The early prospective study of Traq™ (an investigational binocular ophthalmic neurodiagnostic device) will measure binocular ocular functions (bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency) in…
- Conditions
- Mild Traumatic Brain Injury, Concussion, Binocular Visual Function, Neuro-Ophthalmology, Saccadic Eye Movements
- Trial name
- REB-001 (NCT07742878)
- Testing
- Binocular ophthalmic neurodiagnostic device
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rebiscan, Inc.
Concussion
A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.
- Trial name
- NCT02660164
- Testing
- Nautilus BrainPulse Recording
- Where
- 4 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.