Clinical trials: Spinal Cord Injury/Disorder
Spinal Cord Injuries
Safety Stem Cells in Spinal Cord Injury
Mono-center, open label study to investigate the safety of Neuro-Cells in 10 end stage (chronic) traumatic spinal cord injury (TSCI) patients, when administered once intrathecally.
- Trial name
- SSCiSCI (NCT04205019)
- Testing
- Neuro-Cells
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Neuroplast
Neurologic Disorder, Paralysis
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- NCT05041114
- Testing
- Motor Neuroprosthesis
- Where
- 3 sites in Australia
- Sponsor
- Synchron Medical, Inc.
Neurogenic Detrusor Overactivity
Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
- Trial name
- NCT03168828
- Testing
- Trospium-Releasing Intravesical System (TAR-302-5018)
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Taris Biomedical LLC
Neuromuscular Disorders, Neurodevelopmental Disorders
Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.
Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk.
- Trial name
- NCT07159360
- Testing
- CLINICAL EXPLORER
- Where
- 2 sites in Mexico, Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- MarsiBionics
Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS)
Control of Assistive Devices Via Brain-Computer Interface Technology
The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices.
- Conditions
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Quadriplegia, Spinal Cord Injury (SCI)
- Trial name
- CONVOY (NCT06710626)
- Testing
- Assistive Robotic Arm
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Neuralink Corp
Spinal Cord Injuries, Paraplegia and Tetraplegia
Self-balancing Personal Exoskeleton for SCI (WIP)
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
- Trial name
- NCT07536386
- Testing
- Hands-free exoskeleton
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Wandercraft
Acute Spinal Cord Injury
Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.
- Trial name
- NCT04475224
- Testing
- KP-100IT
- Where
- 5 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Kringle Pharma, Inc.
Erectile Dysfunction, Spinal Cord Injury
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
- Trial name
- LEMDE (NCT00667966)
- Testing
- Vardenafil (Levitra, BAY 38-9456), 10 mg, Vardenafil (Levitra, BAY 38-9456), 20 mg
- Where
- 2 sites in Spain
- Volunteers
- 45 people
- Sponsor
- Bayer
SCI - Spinal Cord Injury
Phoenix Exoskeleton for SCI Users
This study will evaluate the Phoenix device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
- Trial name
- NCT03175055
- Testing
- Phoenix
- Where
- 4 sites in United States, Hong Kong
- Volunteers
- 40 people
- Sponsor
- US Bionics
Tetraplegia/Tetraparesis, Quadriplegia
Precise Robotically IMplanted Brain-Computer InterfacE
The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or…
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis
- Trial name
- PRIME (NCT06429735)
- Testing
- N1 Implant, R1 Robot
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Neuralink Corp
Acute Spinal Cord Injury of Traumatic Origin (tSCI)
Surgical Treatment for Spinal Cord Injury
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for…
- Trial name
- SCI-POEM (NCT01674764)
- Testing
- Early surgical intervention, Late surgical intervention
- Where
- 17 sites in Austria, Bulgaria and 10 more
- Volunteers
- 297 people
- Sponsor
- AOSpine Europe
Lower Extremity Motor Dysfunction, Spinal Cord Injury
Evaluation of the Effectiveness and Safety of AI-Robotics
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot
- Trial name
- ART (NCT03452059)
- Testing
- AiLegs, AiWalker and HKAFO
- Where
- China
- Volunteers
- 40 people
- Sponsor
- AI-Robotics Technology Co., Ltd
Urinary Bladder, Neurogenic
Connected Catheter Clinical Feasibility Study( CFS)
The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and…
- Trial name
- NCT03405285
- Testing
- Connected Catheter
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Spinal Singularity
Spinal Cord Injury, Quadriplegia
Electrical Activation of The Diaphragm for Ventilatory Assist
OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis.
- Trial name
- NCT00010374
- Testing
- NeuRx DPS
- Where
- 5 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Synapse Biomedical
Multiple Sclerosis, Muscle Spasticity
Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.
This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride…
- Conditions
- Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury, Stroke
- Trial name
- NCT00047580
- Testing
- tizanidine hydrochloride capsule
- Where
- 16 sites in United States
- Volunteers
- 120 people
- Sponsor
- Elan Pharmaceuticals
Tetraplegia/Tetraparesis, Quadriplegia
UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
The UAE-PRIME Study is a feasibility study designed to assess the initial clinical safety and functionality of the Neuralink N1 Implant and R1 Robot.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury
- Trial name
- UAE-PRIME (NCT06992596)
- Testing
- N1 Implant, R1 Robot
- Where
- United Arab Emirates
- Volunteers
- 10 people
- Sponsor
- Neuralink Corp
Spinal Cord Injuries
Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians.
- Trial name
- NCT04876794
- Testing
- ABLE Exoskeleton
- Where
- 2 sites in Germany, Spain
- Volunteers
- 24 people
- Sponsor
- ABLE Human Motion S.L.
Spinal Cord Injuries
Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training
Umbilical cord blood mononuclear stem cells (UCBMSCs) transplant followed by the intensive locomotor training for up to 5±1 hours a day, 5±1 days a week, and for 3-6 months for treatment in patients with chronic, stable and…
- Trial name
- NCT03979742
- Testing
- Umbilical Cord Blood Mononuclear Cell, Locomotor Training
- Where
- 2 sites in Taiwan
- Volunteers
- 6 people
- Sponsor
- StemCyte, Inc.
Injuries, Spinal Cord
ReWalk Personal Device Postmarket Study
This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical…
- Trial name
- NCT02944669
- Testing
- ReWalk Personal Device
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- ReWalk Robotics, Inc.
Acute Spinal Cord Injury
Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
- Trial name
- NCT00406016
- Testing
- ATI355
- Where
- 14 sites in Canada, Germany and 1 more
- Volunteers
- 52 people
- Sponsor
- Novartis