Clinical trials: Locked-in Syndrome
Locked-in Syndrome, Neuromuscular Diseases
Investigation on the Cortical Communication System
The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems.
- Conditions
- Locked-in Syndrome, Neuromuscular Diseases, Brainstem Stroke, Traumatic Brain Injury
- Trial name
- CortiCom (NCT06207591)
- Testing
- ECoG (electrocorticography) sensing
- Where
- Netherlands
- Volunteers
- 2 people
- Sponsor
- UMC Utrecht
Locked- in Syndrome
A Method for Communication With Arabic Patients Suffering From Classic Locked- in Syndrome
Aim of the work The aim of this study is to test an Arabic alphabet communication system designed to train physicians to communicate with Arabic-speaking patients with LIS.
- Trial name
- NCT05444075
- Testing
- a method for communication
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sohag University
Locked in Syndrome
TDCS-RTMS Intervention for Motor Function
This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University.
- Trial name
- TRIMLiS (NCT07257601)
- Testing
- Repetitive transcranial magnetic stimulation, Transcranial direct current stimulation
- Volunteers
- 72 people
- Sponsor
- Zhujiang Hospital
Locked-in Syndrome
Brain-Computer Interface Implant for Severe Communication Disability
Locked-In Syndrome (LIS) is a devastating condition in which a person has lost the ability to communicate due to motor impairment, while being mentally intact.
- Trial name
- NCT04576650
- Testing
- Summit System
- Where
- United States
- Sponsor
- Johns Hopkins University
Complete Locked-in State
Brain Computer Interface Complete locked-in State Communication
Electroencephalography (EEG) and/or near-infrared spectroscopy (NIRS) based Brain computer interface for communication in patients without any means of communication.
- Trial name
- NCT02980380
- Testing
- Non-invasive brain computer interface
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- University Hospital Tuebingen
Tetraplegia, Locked-in Syndrome
Investigation on the Cortical Communication (CortiCom) System
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor.
- Conditions
- Tetraplegia, Locked-in Syndrome, Brainstem Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- CortiCom (NCT03567213)
- Testing
- Surgical implantation of CortiCom system
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Johns Hopkins University
Locked in Syndrome, ALS (Amyotrophic Lateral Sclerosis)
Evaluation of the Feasibility and Efficacy of a Chronic Brain-computer Interface for Speech Rehabilitation in Patients With Locked-in-syndrome (LIS)
Eighteen million people worldwide are affected by speech disorders. Locked-in syndrome (LIS) represents the most extreme form of communication disability resulting from motor impairment.
- Trial name
- SpeechBCI (NCT07698496)
- Testing
- Chronic speech BCI
- Where
- 4 sites in France
- Volunteers
- 3 people
- Sponsor
- University Hospital, Grenoble
Consciousness Disorders, Locked-In Syndrome
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome…
- Trial name
- NCT02772302
- Testing
- mindBEAGLE EEG-based brain-computer interface
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Acute Brain Injuries, Consciousness Disorders
CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG
Detecting preserved consciousness in brain-injured patients by traditional clinical means requires presence of motor function. Otherwise, patients may be erroneously classified as being in a vegetative state.
- Trial name
- CONNECT-ME (NCT02644265)
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Amyotrophic Lateral Sclerosis, Stroke
Telehealth Implementation of Brain-Computer Interface
Determine if Telehealth intervention can allow/empower a caregiver (who is untrained) to effectively implement and utilize a Brain-Computer Interface for communication with a participant who is "Locked in" following progression…
- Trial name
- NCT05951556
- Testing
- Use of BCI
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Shirley Ryan AbilityLab
Physical Impairments, Cerebral Palsy
Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments
The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation intervention or audio training improves performance on an adaptive communication system that utilizes brain-computer interface (BCI)…
- Conditions
- Physical Impairments, Cerebral Palsy, Cerebral Ataxia, locked-in Syndrome
- Trial name
- MSPi (NCT01964664)
- Testing
- Mindfulness Meditation Training, Audio Group
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Oregon Health and Science University
Disorders of Consciousness
mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness
The goal of this clinical trial is to test how effective the mindBEAGLE device is in allowing people who are unconscious (due to a brain injury or other condition) to communicate using brain waves to answer Yes/No questions.
- Trial name
- NCT06426602
- Testing
- mindBEAGLE daily device use
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Amy Wagner
Healthy, Tetraplegia
Stable and Independent Communication Brain-computer Interfaces
People with locked-in syndrome cannot move their limbs or talk because of a motor impairment, but remain conscious and intellectually awake.
- Conditions
- Healthy, Tetraplegia, Locked-in Syndrome
- Trial name
- NCT03213561
- Testing
- Stable and Independent Brain-computer Interfaces for Communication
- Where
- Switzerland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tomislav Milekovic
Spinal Cord Injury, Amyotrophic Lateral Sclerosis
iBCI Optimization for Veterans With Paralysis
VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis…
- Conditions
- Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome
- Trial name
- NCT05470478
- Testing
- Mobile neural decoding platform (mobile iBCI)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- VA Office of Research and Development
Anarthria, Dysarthria
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with…
- Conditions
- Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries
- Trial name
- BG-Speech-01 (NCT05724173)
- Testing
- BrainGate Neural Interface System
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Leigh R. Hochberg, MD, PhD.
Locked-In Syndrome
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system.
- Trial name
- UNP (NCT02224469)
- Testing
- ECoG (electrocorticography) sensing
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- UMC Utrecht
Anarthria, Dysarthria
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to…
- Conditions
- Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries
- Trial name
- BG-Speech-02 (NCT06094205)
- Testing
- BrainGate Neural Interface System
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Leigh R. Hochberg, MD, PhD.
Locked-In Syndrome；Pulmonary Arteriovenous Malformation
Locked-in Syndrome Caused by Pulmonary Arteriovenous Malformation: A Case Report
In this case, we report a case of atresia syndrome (LIS), a serious neurological disease caused by pulmonary arteriovenous fistula (PAVM).
- Trial name
- NCT05348902
- Testing
- In this study, only cases were collected and reported without any intervention or adverse reactions
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Tetraplegia, Spinal Cord Injuries
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with…
- Conditions
- Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions
- Trial name
- BrainGate2 (NCT00912041)
- Testing
- Placement of the BrainGate2 sensor(s) into the motor-related cortex
- Where
- 6 sites in United States
- Volunteers
- 27 people
- Sponsor
- Leigh R. Hochberg, MD, PhD.
Amyotrophic Lateral Sclerosis, Brainstem Stroke
Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit
This project adds to non-invasive BCIs for communication for adults with severe speech and physical impairments due to neurodegenerative diseases.
- Conditions
- Amyotrophic Lateral Sclerosis, Brainstem Stroke, Muscular Dystrophies, Parkinson's Disease and Parkinsonism
- Trial name
- BCI-FIT (NCT04468919)
- Testing
- BCI-FIT multi-modal access, BCI-FIT adaptive signal modeling, BCI-FIT active querying
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University