Clinical trials: Spinal Disorders/Injuries
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
NG004 in Incomplete Spinal Cord Injury Patients
This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI.
- Conditions
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Spinal Cord Injuries, Trauma Nervous System
- Trial name
- SPROUT-2 (NCT07840196)
- Testing
- NG004
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 120 people
- Sponsor
- NovaGo Therapeutics AG
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
Acquired Brain Injury (Including Stroke), Spinal Cord Injury
Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair…
- Conditions
- Acquired Brain Injury (Including Stroke), Spinal Cord Injury, Multiple Sclerosis
- Trial name
- NCT07550699
- Testing
- ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES)
- Where
- Austria
- Volunteers
- 14 people
- Sponsor
- ABLE Human Motion S.L.
Spinal Cord Injury, Paraplegia and Tetraplegia
Self-balancing Personal Exoskeleton for SCI (WINY)
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
- Trial name
- NCT07222033
- Testing
- Hands-free exoskeleton
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Wandercraft
Vertebral Compression Fracture
Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration
This study will review the safety and possibility of the VCFix Spinal System. This is a proof-of-concept study and an initial review of the surgical procedure and how well the VCFix device works, to who that the VCFix is safe and…
- Trial name
- NCT07259811
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Amber Implants B.V.
Spinal Cord Injury, Safety
Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial
Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord.
- Conditions
- Spinal Cord Injury, Safety, Efficacy, Clinical Trial
- Trial name
- NCT06974968
- Testing
- Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Tetraplegia/Tetraparesis, Quadriplegia
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury
- Trial name
- GB-PRIME (NCT07127172)
- Testing
- N1 Implant, R1 Robot
- Where
- 2 sites in United Kingdom
- Volunteers
- 7 people
- Sponsor
- Neuralink Corp
Spinal Cord Injuries
Intermittent Catheterization in Spinal Cord Injured Men
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
- Trial name
- NCT02230540
- Testing
- SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+, Product B SelfCath and urine bag, Conveen Contour
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- Coloplast A/S
Spinal Cord Injuries
Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design.
- Trial name
- NCT00978341
- Testing
- Pregabalin
- Where
- 4 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Spinal Cord Injury
Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.
- Trial name
- NCT01725880
- Testing
- Observation
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- StemCells, Inc.
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.
Neuromuscular Disorders, Neurodevelopmental Disorders
Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Natural Environments
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk.
- Trial name
- NCT06765070
- Testing
- EXPLORER
- Where
- 6 sites in Spain
- Volunteers
- 15 people
- Sponsor
- MarsiBionics
Spinal Cord Injury
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal cord injury patients.
- Trial name
- ABSCI (NCT01730183)
- Testing
- Bone marrow derived stem cells
- Where
- India
- Volunteers
- 15 people
- Sponsor
- Max Institute of Neurosciences
Spinal Cord Injuries, Trauma, Nervous System
Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with…
- Trial name
- NCT03439319
- Testing
- MyndMove®, Conventional Therapy
- Where
- 4 sites in United States, Canada
- Volunteers
- 51 people
- Sponsor
- MyndTec Inc.
Communication Disorders
Adaptive and Individualized AAC
This project will test the feasibility of developing a smart augmentative or alternative communication (AAC) system that is effective in delivering communication capabilities that automatically adapt to the users' physical…
- Trial name
- NCT04247828
- Testing
- Experimental AAC, Generic AAC
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Altec Inc.
Acute Spinal Cord Injury
AC105 in Patients With Acute Traumatic Spinal Cord Injury
The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.
- Trial name
- AC105 (NCT01750684)
- Testing
- AC105
- Volunteers
- 15 people
- Sponsor
- Acorda Therapeutics
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
Spinal Cord Injuries, Gait Disorders, Neurologic
Safety and Feasibility of TWIICE Rise - Phase 2
The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.
- Trial name
- NCT07461259
- Testing
- TWIICE Rise
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- TWIICE
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Spinal Duraplasty
Adherus™ Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
- Trial name
- NCT04498026
- Testing
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Where
- 14 sites in United States
- Volunteers
- 94 people
- Sponsor
- Stryker Craniomaxillofacial