RECRUITING

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

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 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 speak fluently to communicate via a computer just by trying to speak.

Official Title

Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface

Quick Facts

Study Start:2023-10-16
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06094205

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. * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
  3. * Complete or incomplete tetraplegia (quadriplegia)
  4. * Must live 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, M.D., Ph.D.
CONTACT
617-724-9247
lhochberg@mgh.harvard.edu
Sergey Stavisky, Ph.D.
CONTACT
530-754-3413
sstavisky@ucdavis.edu

Principal Investigator

Sergey Stavisky, Ph.D.
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: Leigh R. Hochberg, MD, PhD.

  • Sergey Stavisky, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Davis

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 Date2023-10-16
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2027-08-31

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