Clinical trials: Brain Injury
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
Chronic Traumatic Encephalopathy
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
- Trial name
- NCT02079766
- Testing
- florbetapir F 18, Flortaucipir F18
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Cerebral Palsy
Development of a Robotic Ankle Assist Device
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and…
- Trial name
- NCT04516343
- Testing
- Robotic Ankle Assist Device (RAAD)
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- BiOMOTUM, Inc.
PTSD
Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.
- Trial name
- NCT04030169
- Testing
- Midomafetamine HCl
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 21 people
- Sponsor
- MAPS Europe B.V.
Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury
Dysport® Adult Lower Limb Spasticity Follow-on Study
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
- Trial name
- NCT01251367
- Testing
- Botulinum toxin type A
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 352 people
- Sponsor
- Ipsen
Traumatic Brain Injury
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury…
- Trial name
- NCT00983437
- Testing
- Armodafinil
- Where
- 61 sites in United States
- Volunteers
- 49 people
- Sponsor
- Cephalon, Inc.
Alzheimer's Disease, Traumatic Brain Injury
Clinical Evaluation of Flortaucipir F 18
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate…
- Conditions
- Alzheimer's Disease, Traumatic Brain Injury, Depression
- Trial name
- NCT02278367
- Testing
- Flortaucipir F18, Brain PET scan
- Where
- 5 sites in United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Chronic Troublesome Sialorrhea, Parkinson's Disease
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of…
- Conditions
- Chronic Troublesome Sialorrhea, Parkinson's Disease, Post-stroke, Traumatic Brain Injury
- Trial name
- SIAXI (NCT02091739)
- Testing
- IncobotulinumtoxinA (100 Units), IncobotulinumtoxinA (75 Units)
- Where
- 31 sites in Germany, Poland
- Volunteers
- 184 people
- Sponsor
- Merz Pharmaceuticals GmbH
Sequelae of Perinatal Brain Injury
Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
Purpose of the study: To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral…
- Trial name
- NCT03159611
- Testing
- Tenoten for children
- Where
- 10 sites in Russia
- Volunteers
- 182 people
- Sponsor
- Materia Medica Holding
Brain Injuries
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
- Trial name
- SyNAPSe (NCT01143064)
- Testing
- Progesterone, Lipid emulsion without progesterone
- Where
- 156 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- BHR Pharma, LLC
Cerebral Palsy
Intelligent and Adaptive Control Applied to Powered Walkers
The research is towards an advanced control and computer learning strategy that will intelligently drive a powered walker for people with walking disabilities.
- Trial name
- NCT05465239
- Testing
- SurePace Powered Walker User
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Barron Associates, Inc.
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, 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
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Cerebral Palsy, Gait Disorders, Neurologic
Precision Gait Retraining for Children With Cerebral Palsy
This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children…
- Trial name
- NCT04717323
- Testing
- mPAD (or TPAD) Pelvic Assist Device, No Intervention
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Altec Inc.
Neurobehavioral Disinhibition
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury…
- Trial name
- NCT03095066
- Testing
- AVP-786-28, AVP-786-42.63
- Where
- 54 sites in United States
- Volunteers
- 168 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Small/Large Bowel
PillCam SB3 Capsule- Feasibility Study
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation…
- Trial name
- NCT01433042
- Testing
- capsule endoscopy
- Where
- 4 sites in Israel, Romania and 2 more
- Volunteers
- 225 people
- Sponsor
- Medtronic - MITG
Cerebral Palsy, Multiple Sclerosis
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
- Trial name
- NCT01117090
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- MedtronicNeuro
Cerebral Palsy (CP)
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function
- Trial name
- NCT01468350
- Testing
- dalfampridine-ER 10mg
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Acorda Therapeutics