Clinical trials: Mild Traumatic Brain Injury (mTBI)
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
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.
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.
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
Mild Traumatic Brain Injury
A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion
The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes.
- Trial name
- NCT01673464
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Concussion
A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)
The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of mTBI in adolescents and adults.
- Trial name
- NCT02100150
- Testing
- NNZ-2566
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Neuren Pharmaceuticals Limited
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.
Traumatic Brain Injury, Concussion, Mild
Rapid Biochemical Diagnostics of Traumatic Brain Injury
The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection.
- Conditions
- Traumatic Brain Injury, Concussion, Mild, Bone Fracture
- Trial name
- NCT03306563
- Testing
- Sample collection
- Where
- 3 sites in Finland
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Medicortex Finland Oy
Brain Injuries, Traumatic
mTBI Identification and Monitoring Through Retinal Scanning
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan.
- Trial name
- NCT06142435
- Testing
- Head and Intraocular Trauma Tool
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Rebiscan, Inc.
Mild Traumatic Brain Injury, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury
This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic…
- Trial name
- TBI (NCT02070588)
- Testing
- MRI
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Mild Traumatic Brain Injury
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function.
- Trial name
- NCT01535339
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Mild Traumatic Brain Injury, Concussion
Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
The goal is to assess the potential benefit of stochastic galvanic vestibular stimulation (sGVS) in improving patient performance with respect to balance, gait, and/or overall vestibular function for individuals with known…
- Trial name
- NCT07466589
- Testing
- Stochastic Galvanic Vestibular Stimulation (sGVS)
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Vivonics, Inc.
Mild Traumatic Brain Injury, Concussion, Mild
Exercise as Concussion Therapy Trial- 2
This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise)compared to a reference therapy (passive stretching) in patients who have sustained mTBI.
- Trial name
- ExACTT (NCT04578743)
- Testing
- Graded Exercise Therapy: ClearPlay(TM)
- Where
- 3 sites in Australia
- Volunteers
- healthy volunteers welcome
- Sponsor
- ANSwers Neuroscience, Inc.
Traumatic Brain Injury
Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with…
- Trial name
- BRAVE (NCT01640158)
- Testing
- Computerized Plasticity-based Adaptive Cognitive Training, Commercially available computerized training
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Posit Science Corporation
Concussion, Mild, Concussion, Intermediate
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
This study is designed to evaluate the use of a collection of tests that measure the eye response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI.
- Conditions
- Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- NKI-RIF1 (NCT01832714)
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Neurolign
Concussion
Vascular Assessment of Regulation Index Arrays Registry
The objective of this patient registry is to collect and analyze physiological data associated with baseline and brain injury identified in standard clinical practice (Normal Values, Recovery Curves, Correlation between Symptoms…
- Trial name
- VARIA (NCT02435082)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- NeuroChaos Solutions, Inc.
Brain Injuries, Traumatic, Concussion, Brain
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
This study (Part 2) 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, Brain, Concussion, Mild, Concussion, Intermediate
- Trial name
- AheadCAS-HS (NCT02661633)
- Testing
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Where
- 4 sites in United States
- Volunteers
- 177 people
- Sponsor
- BrainScope Company, Inc.
Concussion, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between…
- Trial name
- mTBI-phase2 (NCT02556177)
- Testing
- MRI
- Where
- 7 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- 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
HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with…
- Trial name
- HeadSMART II (NCT04423198)
- Testing
- Cognitive Assessment, Patient Reported Neurological Outcome Assessments, Blood Draw
- Where
- 11 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- BRAINBox Solutions Inc