Clinical trials: Concussion, Mild
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
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.
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.
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
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.
Brain Injuries, Traumatic, Concussion, Mild
Objective Brain Function Assessment of mTBI/Concussion in College Athletes
This study (Part 1) 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, Brain, Concussion, Intermediate
- Trial name
- AheadCAS (NCT02477943)
- Testing
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Where
- 11 sites in United States
- Volunteers
- 520 people
- Sponsor
- BrainScope Company, 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.
Vestibular Diseases, Labyrinth Diseases
Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who…
- Conditions
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases
- Trial name
- SEMD (NCT01483937)
- Testing
- Usual care physical therapy plus SEMD, Usual care physical therapy only
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Karen L Atkins
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.
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.
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.
Mild Traumatic Brain Injury
SSVEP Evaluation of Brain Function (PRO)
The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP.
- Trial name
- NCT06013566
- Testing
- SSVEP
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Headsafe MFG
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.
Concussion, Brain
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults
Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion…
- Trial name
- NCT03249675
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ElMindA Ltd
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.
Brain Concussion, Mild Cognitive Impairment
Development of a Neurocognitive Screening Test
This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.
- Trial name
- NCT02597504
- Testing
- Pen and paper neuropsychological test, Quick Test
- Where
- 4 sites in United States
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- ImPACT Applications, Inc.
mTBI - Mild Traumatic Brain Injury
MindRhythm Detection of Concussion and Recovery Study
This study is designed to observe HeadPulse data in concussed subjects that may have experienced a concussion via an injury down to the age of 4.
- Trial name
- DISCOVERY (NCT07190963)
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- MindRhythm, Inc.
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.
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