Clinical trials: Head Injury Trauma
Brain Injuries, Traumatic
Biomarkers of Traumatic Brain Injury With Tbit System
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard…
- Trial name
- NCT04107662
- Testing
- Tbit system
- Volunteers
- 740 people
- Sponsor
- BioDirection Inc
Cerebral Palsy, Acquired Brain Injury
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.
- Conditions
- Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
- Trial name
- NCT05914818
- Testing
- EXPLORER V2
- Where
- 5 sites in Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MarsiBionics
Spinal Cord Injury, Acquired Brain Injury
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can be very heterogeneous. For this reason, STELO has been developed: a new concept of exoskeleton based on modular technology for gait…
- Trial name
- NCT05265377
- Testing
- Stelo
- Where
- 3 sites in Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MarsiBionics
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.
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, 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
Brain Injuries, Traumatic Brain Injury
Tbit System Precision and Correlation of Different Blood Samples
The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be…
- Trial name
- NCT04478812
- Testing
- Single Group Assignment
- Volunteers
- 81 people
- Sponsor
- BioDirection Inc
Acquired Brain Injury (Including Stroke)
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.
- Trial name
- NCT07050875
- Testing
- ABLE Exoskeleton
- Where
- 3 sites in Spain
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Stroke, Brain Injuries, Traumatic
Evaluation of a Novel Gait Training Device to Support Body Weight
A novel body weight support device that uses pressurized pants may provide advantages in delivering gait therapy. The objectives of this study are to test the following hypotheses that 1) the novel device will allow for increased…
- Conditions
- Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries, Gait Disorders, Neurologic
- Trial name
- NCT03171207
- Testing
- Lite Run Gait Trainer, Current Harness System
- Volunteers
- 10 people
- Sponsor
- Lite Run Inc.
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
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
Brain Injuries
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients
Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular…
- Trial name
- CBMS FIH (NCT03249220)
- Testing
- Placement of the CBMS Probe
- Where
- 2 sites in Switzerland
- Volunteers
- 1 people
- Sponsor
- Carag AG
Brain Concussion
Blood Biomarker Study to Diagnose Adolescent Sport Concussion
Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard.
- Trial name
- NCT05287997
- Testing
- Neurolytixs Index
- Where
- 2 sites in United States, Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Neurolytixs
Chronic Troublesome Sialorrhea, Cerebral Palsy
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g.
- Conditions
- Chronic Troublesome Sialorrhea, Cerebral Palsy, Stroke, Traumatic Brain Injury
- Trial name
- SIPEXI (NCT02270736)
- Testing
- NT 201
- Where
- 31 sites in Georgia, Hungary and 4 more
- Volunteers
- 256 people
- Sponsor
- Merz Pharmaceuticals GmbH
Spasticity
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension…
- Trial name
- NCT04099667
- Testing
- Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 40 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
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.
Zygomaticomaxillary Complex Fracture, Zygomatic Fractures
BoneTape Feasibility Trial
This study aims to evaluate the safety, effectiveness, and usability of BoneTape, an innovative medical device designed to fix facial bone fractures, specifically in the zygomaticomaxillary (midface) region.
- Conditions
- Zygomaticomaxillary Complex Fracture, Zygomatic Fractures, Zygoma Fracture
- Trial name
- NCT06600854
- Testing
- BoneTape
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Cohesys Inc.
Retinal Disease, Age-Related Macular Degeneration
Stem Cell Ophthalmology Treatment Study II
This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.
- Conditions
- Retinal Disease, Age-Related Macular Degeneration, Retinitis Pigmentosa, Stargardt Disease
- Trial name
- SCOTS2 (NCT03011541)
- Testing
- Arm 1
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
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
Traumatic Brain Injury
To Compare the Effect of Receiving the Technology-based Training Along With the Conventional Therapy to the Conventional Therapy Alone on Executive Functions Among People With Traumatic Brain Injury With Mild to Moderate Cognitive Deficit
The goal of this clinical trial is to compare the effect of receiving the technology-based training along with the conventional therapy to the conventional therapy alone on executive functions among people with traumatic brain…
- Trial name
- NCT06080269
- Testing
- technology based intervention along with conventional therapy, conventional therapy alone
- Where
- Qatar
- Volunteers
- 60 people
- Sponsor
- Hamad Medical Corporation