Clinical trials: MTBI - Mild Traumatic Brain Injury
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.
Healthy
Normative Oculomotor and Vestibular Data in Pediatric Population
The purpose of this study is to use a device called I-Portal® Portable Assessment System (I-PAS) to record eye movements in response to a number of visual and auditory stimuli designed to evaluate neural brain pathways related to…
- Trial name
- NCT04107610
- Testing
- I-PAS
- Where
- 2 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Neurolign
Concussion, Mild, TBI (Traumatic Brain Injury)
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment
mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion.
- Conditions
- Concussion, Mild, TBI (Traumatic Brain Injury), Mild Traumatic Brain Injury
- Trial name
- NCT03265912
- Where
- 2 sites in United States
- Volunteers
- 46 people
- 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.
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.
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.
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
Mild Traumatic Brain Injury
SSVEP Evaluation of Brain Function
The investigational device used in this clinical investigation, the Nurochek Headset, is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP.
- Trial name
- NCT05614570
- Testing
- SSVEP Device, SCAT5
- Where
- Australia
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Headsafe MFG
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
Brain Concussion, Vestibular Disorder
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI
The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with…
- Conditions
- Brain Concussion, Vestibular Disorder, Cognition Disorder, Mild Traumatic Brain Injury
- Trial name
- Praxis (NCT06314464)
- Testing
- Praxis, Supervised cardiovascular exercise
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- BlueHalo
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
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
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
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
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, 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.
Concussion, Brain, Mild Traumatic Brain Injury
Oculogica Portable EyeBOX Study
The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion.
- Trial name
- RESTLESS (NCT05047003)
- Testing
- EyeBOX Model EBX-4 (Portable version)
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- Oculogica, 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.
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.