Clinical Trials Logo
  1. Home
  2. Neurologic Disorder
  3. NCT03834857

SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device

Neurologic Disorder Clinical Trial

Official title:
Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study (EFS) of the Safety of the Stentrode Device in Participants With Loss of Motor Function Due to Paralysis

Clinical Trial Summary

SWITCH Study

Clinical Trial Description

STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the safety of the StentrodeTM device in participants with loss of motor function due to paralysis from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs. Research has shown that in individuals with neurological conditions, brain signals can be recorded using electrical sensors implanted on to the brain. These signals could be used by the individuals to control assistive technology (e.g. spelling devices) that help with daily life, just by thinking. However, implanting these electrical sensors often requires open brain surgery. A new medical device and surgical technique has been developed, which allows implantation of the electrical sensors without open brain surgery. The device, called Stentrode™, is a small metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent structure. It can be placed inside a blood vessel of the brain located in the motor cortex. This does not involve open brain surgery. The purpose of this research is to evaluate the safety of the Stentrode™ device in humans. This is an experimental device. This research will be the first of its kind to be performed in humans and may help find safer, more effective ways to introduce/implant electrical sensors in patients. This could foster the development of user friendly biotechnology for patients with neurological conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03834857
Study type Interventional
Source Synchron, Inc.
Contact
Status Completed
Phase N/A
Start date May 27, 2019
Completion date January 9, 2022
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05519592 - Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait N/A
Recruiting NCT04098679 - Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)
Completed NCT03946137 - Chest Therapy and Postural Education in Children With Cerebral Palsy N/A
Completed NCT05217186 - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Not yet recruiting NCT05506306 - Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients
Recruiting NCT05260190 - Manual Dexterity Modifications After Application of tSMS Over the Primary Motor Cortex (M1) N/A
Recruiting NCT04846413 - Voice Analysis in Patients With Neurologic Diseases
Not yet recruiting NCT04906681 - Implementation of a Rehabilitation Technology in Orthopedic and Neurological Rehabilitation to Increase Therapy Dosage: an Exploratory Study Phase 1/Phase 2
Completed NCT04743037 - Interactive Self-Management Augmented by Rehabilitation Technologies N/A
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Active, not recruiting NCT04631965 - Healthcare Transition of Adolescents With Chronic Health Conditions
Recruiting NCT05132517 - Magnesium and Cognition After Stroke
Recruiting NCT04100993 - Multisystem and Autonomic Complications of NMD on Long-term NIV
Recruiting NCT05652946 - IISART (International Industry Society of Advanced Rehabilitation Technology) Advanced Rehabilitation Technology Study N/A
Recruiting NCT06146543 - Stress Ball During Lumbar Puncture the Effect of the Application on Anxiety Level N/A
Completed NCT06368024 - Establishment of Delphi-MD Safety Performance and Reliability
Not yet recruiting NCT06169696 - EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis N/A
Completed NCT03329872 - Neuro-Orthopedic Registry of the University Hospital of Toulouse
Completed NCT05483244 - Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis
Completed NCT04170985 - NeuroSeq: A Prospective Trial to Evaluate the Diagnostic Yield of Whole Genome Sequencing (WGS) in Adult Neurology