RECRUITING

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Official Title

Intuitive, Complete Neural Control of Tablet Computers for Communication

Quick Facts

Study Start:2024-07-22
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06511934

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
  2. * Complete or incomplete tetraplegia (quadriplegia)
  3. * Must live within a three-hour drive of the Study site
  4. * Prior enrollment in BrainGate2 clinical trial (NCT00912041)
  1. * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
  2. * Chronic oral or intravenous steroids or immunosuppressive therapy
  3. * Other serious disease or disorder that could seriously affect ability to participate in the study

Contacts and Locations

Study Contact

Leigh R Hochberg, MD, Ph.D
CONTACT
617-724-9247
lhochberg@mgh.harvard.edu

Principal Investigator

Leigh R Hochberg, MD, Ph.D.
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Masssachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Leigh R. Hochberg, MD, PhD.

  • Leigh R Hochberg, MD, Ph.D., PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2024-07-22
Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Brainstem Stroke
  • ALS
  • Tetraplegia
  • Spinal Cord Injuries
  • Cervical Spinal Cord Injury