ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Spinal Cord Injury Clinical Trial

Official title:

Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393444
• Other study ID #: PRO10010149
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: July 19, 2016
• Start date: May 2011
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.

Description:

Brain-computer interface (BCI) technology aims to establish a direct link for transmitting information between the brain and external devices, offering a natural and rich control signal for prosthetic hands or functional electrical stimulators (FES) to re-animate paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity using electrodes implanted on the surface of the brain. Each participant will undergo testing of the ECoG direct brain interface for up to 29 days. Participants will learn to control computer cursors, virtual reality environments, and assistive devices such as hand orthoses and functional electrical stimulators using neural activity recorded with the ECoG sensor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Limited or no ability to use both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases

• At least 1 year post-injury

• Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh while the ECoG electrode is implanted (up to 29 days)

• Additional inclusion criteria must also be reviewed

Exclusion Criteria:

• Certain implanted devices

• Presence of other serious disease or disorder that could affect ability to participate in this study

• Additional exclusion criteria must also be reviewed

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• ALS
• Brachial Plexus Injury
• Brain Stem Infarctions
• Brainstem Stroke
• Muscular Dystrophies
• Muscular Dystrophy
• Paralysis
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia
• Wounds and Injuries

Intervention

Device:
• Implantation of ECoG sensors on the brain surface
One ECoG sensor will be implanted over the motor cortex of study participants

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the successful control of a variety of external devices using neural data recorded with ECoG.	Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.	Up to 29 days of device implantation	No
Secondary	A secondary outcome is to demonstrate that individuals with upper limb paralysis can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain-computer interface system.	Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.	Up to 29 days of device implantation	No

External Links

•   Brain Computer Interface Research at University of Pittsburgh Medical Center (UPMC) / University of Pittsburgh