Clinical trials: TBI-Traumatic Brain Injury
Mild Traumatic Brain Injury
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software…
- Trial name
- CogMind (NCT02922569)
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training, Mindfulness Training
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Posit Science Corporation
Post-Concussion Syndrome
ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic…
- Trial name
- NCT04744051
- Testing
- 50 Adipose Derived Stem Cell Infusion, 150 Adipose Derived Stem Cell Infusion, 300 Adipose Derived Stem Cell Infusion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- American CryoStem Corporation
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.
Pseudobulbar Affect (PBA), Stroke
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with…
- Conditions
- Pseudobulbar Affect (PBA), Stroke, Dementia, Traumatic Brain Injury (TBI)
- Trial name
- PRISM II (NCT01799941)
- Testing
- Nuedexta (DM 20 mg/Q 10 mg)
- Where
- United States
- Volunteers
- 367 people
- Sponsor
- Avanir Pharmaceuticals
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.
PostTraumatic Stress Disorder, Traumatic Brain Injury
Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder
The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post-Traumatic Stress Disorder
- Conditions
- PostTraumatic Stress Disorder, Traumatic Brain Injury, Postconcussive Symptoms
- Trial name
- MeRT-005-B (NCT02990793)
- Testing
- Active MeRT Treatment
- Where
- 8 sites in United States
- Volunteers
- 158 people
- Sponsor
- Wave Neuroscience
Intracranial Hemorrhages, Traumatic Brain Injury
Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH…
- Trial name
- NCT04642443
- Testing
- SENSE Device
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Sense Diagnostics, LLC
Traumatic Brain Injury
Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
The main goal of this clinical trial is to check if the treatment is safe and well-tolerated. Researchers will compare the MR-301 active drug group with the placebo group to evaluate the safety and tolerability of the drug.
- Trial name
- NCT06253923
- Testing
- Amantadine Hydrochloride
- Where
- 13 sites in United States
- Volunteers
- 45 people
- Sponsor
- SHINKEI Therapeutics, Inc
Traumatic Brain Injury
Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma
The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured…
- Trial name
- VIGILANT (NCT02541123)
- Testing
- Blood draw
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 194 people
- Sponsor
- Banyan Biomarkers, Inc
Traumatic Brain Injury
Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)
The primary objective of this study is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury (TBI).
- Trial name
- STOP-TBI (NCT00908063)
- Testing
- Oxycyte, Normal Saline
- Where
- 6 sites in Israel, Switzerland
- Volunteers
- 18 people
- Sponsor
- Tenax Therapeutics, Inc.
Traumatic Brain Injury
A Study to Evaluate the SENSE Device's Ability to Detect TBI
The study population will consist of 3 mutually-exclusive sets of patients and subjects: TBI patients with intracranial bleeding TBI patients without intracranial bleeding Control subjects with normal brain health.
- Trial name
- SENSE-007 (NCT06828107)
- Testing
- SENSE device
- Where
- 6 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sense Diagnostics, LLC
Trauma, Brain Injuries
Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status
Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge.
- Conditions
- Trauma, Brain Injuries, Stress Reaction, Beta Blockers
- Trial name
- BBTBBT (NCT04508244)
- Testing
- Propranolol
- Where
- Qatar
- Volunteers
- 771 people
- Sponsor
- Hamad Medical Corporation
Chronic Traumatic Brain Injury, TBI (Traumatic Brain Injury)
Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
The purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI)…
- Trial name
- NCT07730099
- Testing
- Deep brain stimulation
- Volunteers
- 40 people
- Sponsor
- ReEmerge, Inc.
Nervous System Disorders
Dysport® Adult Upper Limb Spasticity
The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.
- Trial name
- NCT01313299
- Testing
- Botulinum toxin type A
- Where
- 40 sites in United States, Belgium and 7 more
- Volunteers
- 243 people
- Sponsor
- Ipsen
Traumatic Brain Injury
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy)…
- Trial name
- NCT00287157
- Testing
- Sublingual Tizanidine HCl
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Teva GTC
Spasticity, Cerebrovascular Accident
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper 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 upper limb spasticity in adults followed by an open-label extension…
- Conditions
- Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury
- Trial name
- NCT04815967
- Testing
- Phase 2; Low Dose MYOBLOC (10,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 32 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Nervous System Disorders
Dysport® Adult Upper Limb Spasticity Extension Study
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
- Trial name
- NCT01313312
- Testing
- Botulinum toxin type A
- Where
- 34 sites in United States, Belgium and 7 more
- Volunteers
- 258 people
- Sponsor
- Ipsen
Brain Injuries, Growth Hormone Deficiency
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
- Trial name
- NCT00555009
- Testing
- Genotropin
- Where
- 9 sites in France, Italy and 4 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
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
Alzheimer's Disease, Stroke
Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)
The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).
- Conditions
- Alzheimer's Disease, Stroke, Parkinson's Disease, Traumatic Brain Injury
- Trial name
- NCT00056524
- Testing
- AVP-923
- Where
- 39 sites in United States
- Volunteers
- 600 people
- Sponsor
- Avanir Pharmaceuticals