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A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00786032
First received: November 4, 2008
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

The goal of this VA demonstration project is to show that the Brain-computer interface (BCI) technology is a clinically practical and important new communication and control option that can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will test four well-supported hypotheses: (1) that people with ALS who find (or will soon find) conventional assistive technology inadequate can and will use a BCI system for important purposes in their daily lives without close technical oversight, 2) they will continue and even increase this use throughout the period of the study, (3) that BCI use will improve their lives, and 4) BCI will improve the lives of their families and caregivers.


Condition Intervention Phase
ALS (Amyotrophic Lateral Sclerosis)
 Device: Brain Computer Interface (BCI)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #567 - A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • BCI System Installation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Facility Support of the BCI Systems [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Economic Impact on the VHA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BCI Usage by and Impact on the ALS Patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BCI Impact on the Significant Other and Systems Operator [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
All participants will use the BCI System as a means of communication.
 Device: Brain Computer Interface (BCI)
A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
  • Subject has lost the ability to communicate verbally (Score of 0 on Item #1 of the ALSFRS-R).

Exclusion Criteria:

  • Non-veteran.
  • Subject is unable to communicate with caregiver and study personnel willingness and understanding of the consent form (using their existing method of communication).
  • Subject is unable to communicate non-verbally with their significant other and systems operator, or with study personnel.
  • Subject is unable to identify one significant other.
  • Subject is unable to identify one systems operator (person that agrees to be trained and set up the BCI). This person can be the significant other.
  • Significant other and systems operator are unable to indicate willingness and understanding of the consent form, age <18, and do not expect to be with the subject for at least one year.
  • Visual acuity uncorrectable to at least 20/80.
  • Unable to read and comprehend 6th grade text on a computer screen.
  • Subject is not living at home.
  • Subject's residence is greater than 100 miles from the participating site.
  • Subjects age <18.
  • Subject, significant other or systems operator do not have a life expectancy of at least one year.
  • In the opinion of the BCI installation team, the home environment is not physically and technologically conducive to the BCI operation and use.
  • Subject is unable to demonstrate during the screening phase sufficient EEG interaction for the BCI to operate, i.e. classification rate of 70%. Classification rate is defined as the proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the subject attends to and selects specific predefined characters.
  • Significant other and systems operator are unable to demonstrate during the screening phase sufficient skill to manage the daily set-up and routine operations needed for the subject's basic operation of the BCI.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786032

Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, New York
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, United States, 12208
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Department of Veterans Affairs
New York State Department of Health
Investigators
Study Chair: Robert Ruff, MD PhD VA Medical Center, Cleveland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00786032     History of Changes
Other Study ID Numbers: 567
Study First Received: November 4, 2008
Last Updated: April 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Amyotrophic Lateral Sclerosis
Brain Computer Interface (BCI)
Lou Gehrig's disease

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013