BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
15
Phase:
Treatment Type:
Device
Trial Type:
Open Label
Sponsor:
Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

an PALS use a DPS in the trial?
N/A

Update Notes:

9/15/2016No significant updates
10/9/2015No significant updates.
3/9/2015Contact information updated.
3/28/2014Recruitment locations updated.
2/22/2013

Locations:

Massachusetts General Hospital, Boston, 02114
Stanford University School of Medicine, Stanford, 94305
Case Western Reserve University, Cleveland, 44106
Providence VA Medical Center, Providence, 02908

Other Information:

Purpose: The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Eligibility: 18 years to 75 years. Both genders. No healthy volunteers.
Details: The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis to recover a host of abilities that normally rely on the hands.
Collaborator(s):
ALS Forum:
First Published on Clinicaltrials.gov: 6/1/2009
ClinicalTrials.gov ID: NCT00912041
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov