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

This study has been completed.
Sponsor:
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00786032
First received: November 4, 2008
Last updated: January 6, 2015
Last verified: January 2015
  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
ALS (Amyotrophic Lateral Sclerosis)
Device: BCI Device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cooperative Studies Program (CSP) #567 - A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • BCI System Usage by the ALS Patient [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.

  • BCI System Usage by the ALS Patient [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.

  • BCI System Usage by the ALS Patient [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate - The proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged.

  • BCI System Usage by the ALS Patient [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate - The proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users.


Secondary Outcome Measures:
  • BCI Usage by and Impact on the ALS Patient [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.

  • Time of BCI Impact on the Significant Other and Systems Operator [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).

  • Facility Support Speed of Solution [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.


Enrollment: 27
Study Start Date: September 2011
Study Completion Date: August 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BCI Device
All participants will use the BCI System as a means of communication.
Device: BCI Device
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.
Other Name: Brain Computer Interface Device (BCI)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects were patients at five VA medical centers who were severely disabled by amyotrophic lateral sclerosis (ALS).
Criteria

Inclusion and Exclusion Criteria

  1. Subject will be a veteran with El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
  2. Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) .
  3. Subject will be an adult (age >18).
  4. Subject will be living at home.
  5. Subject will be living within 100 miles of the participating study site.
  6. Subject will have corrected visual acuity of at least 20/80.
  7. Subject will have the ability to read and understand 6th grade English text on a computer screen.
  8. Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication).
  9. Subject will be able to identify one significant other.
  10. Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other.
  11. Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel.
  12. Significant other, caregiver and system operator will be able to indicate willingness and understanding of the consent form, be adults (age> 18) and expect to be with the subject for at least one year.
  13. Subject, significant other, caregiver and system operator will have life expectancy of at least one year.
  14. In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use.
  15. Subject will 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 patient attends to and selects specific predefined characters.
  16. Significant other, caregiver and system operator will 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
VA Office of Research and Development
New York State Department of Health
Investigators
Study Chair: Robert Ruff, MD PhD VA Medical Center, Cleveland
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00786032     History of Changes
Other Study ID Numbers: 567 
Study First Received: November 4, 2008
Results First Received: March 26, 2014
Last Updated: January 6, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Amyotrophic Lateral Sclerosis
Brain Computer Interface (BCI)
Lou Gehrig's disease

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

ClinicalTrials.gov processed this record on September 30, 2016