Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06094205
Other study ID # 2009p000505
Secondary ID 1DP2DC021055
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date August 31, 2027

Study information

Verified date December 2023
Source Massachusetts General Hospital
Contact Leigh R. Hochberg, M.D., Ph.D.
Phone 617-724-9247
Email lhochberg@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.


Recruitment information / eligibility

Status Recruiting
Enrollment 2
Est. completion date August 31, 2027
Est. primary completion date August 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders - Complete or incomplete tetraplegia (quadriplegia) - Must live within a three-hour drive of the Study site (There are additional inclusion criteria) Exclusion Criteria: - Between 18 and 80 years of age. - The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication. - Complete or incomplete tetraplegia (quadriplegia) - A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening. - Per clinical opinion, a life expectancy of greater than 6 months. - Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. (There are additional exclusion criteria)

Study Design


Intervention

Device:
BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex

Locations

Country Name City State
United States University of California, Davis Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Leigh R. Hochberg, MD, PhD. National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and:
the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.
there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
1 year
Secondary Decoded speech output accuracy The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are:
The word error rate of speech that is output by the System
The phoneme error rate of speech that is output by the System
At participant exit from study, or up to 5 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05484557 - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Completed NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A