Clinical trials: mTBI - Mild Traumatic Brain Injury
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
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
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.
Traumatic Encephalopathies, Chronic, Concussion, Mild
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental…
- Conditions
- Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- C-TBI (NCT02959294)
- Testing
- Microcannula Harvest Adipose, Centricyte 1000, Sterile Normal Saline IV deployment AD-cSVF
- Where
- United States
- Sponsor
- Robert W. Alexander, MD, FICS
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.
Traumatic Brain Injury
NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury
A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild…
- Trial name
- SAMURAI (NCT04861688)
- Testing
- Traditional Chinese Medicine (NeuroAiD II™ (MLC901)
- Where
- 4 sites in Russia
- Volunteers
- 182 people
- Sponsor
- Moleac Pte Ltd.
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
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 Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury - UCSF
This hypothesis-generating feasibility study compares mTBI Patients and Controls using advanced MRI Applications.
- Trial name
- TBI-2 (NCT02141360)
- Testing
- MRI Diagnostic
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- GE Healthcare
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.
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
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
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
VIDAS® TBI Real Life Performance in Subjects With Mild Traumatic Brain Injury (mTBI)
Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured.
- Trial name
- NCT06449183
- Testing
- VIDAS® TBI Test [GFAP and UCH-L1 assays]
- Where
- 5 sites in United States
- Volunteers
- 903 people
- Sponsor
- BioMérieux
Brain Injuries, Traumatic
Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
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
- NCT05092295
- Testing
- Head and Intraocular Trauma Tool, SCAT-5
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Rebiscan, 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.
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
Traumatic Brain Injury
Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred.
- Trial name
- NCT01532271
- Where
- United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
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
Traumatic Brain Injury, Concussion, Brain
Understanding Concussion/Mild Traumatic Brain Injury
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
- Trial name
- NCT03381638
- Testing
- Blink Reflexometer
- Where
- 5 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- Blinktbi, Inc.