RECRUITING

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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

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 their thoughts.

Official Title

Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis

Quick Facts

Study Start:2023-10-18
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05724173

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. * Between 18 and 80 years of age.
  2. * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
  3. * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
  4. * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
  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
Jaimie Henderson, MD
CONTACT
650-723-5574
henderj@stanford.edu

Principal Investigator

Jaimie Henderson, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University School of Medicine
Stanford, California, 94305
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Leigh R. Hochberg, MD, PhD.

  • Jaimie Henderson, MD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Date2023-10-18
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Anarthria
  • Dysarthria
  • Tetraplegia
  • Spinal Cord Injuries
  • Amyotrophic Lateral Sclerosis
  • Brain Stem Infarctions
  • Locked in Syndrome
  • Muscular Dystrophies