An In-home Study of Brain Computer Interfaces

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Jane Huggins, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01123200
First received: May 4, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices.

This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.


Condition Intervention
Amyotrophic Lateral Sclerosis
Device: Brain Computer Interface for Wheelchair Tilt Control

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An In-home Study of Brain Computer Interfaces

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Duration of BCI usage by persons with ALS. [ Time Frame: As long as they continue to use the BCI ] [ Designated as safety issue: No ]
    Data will be collected on subject who use the BCI, including accuracy, amount of time used and other measures.


Estimated Enrollment: 6
Study Start Date: January 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Brain Computer Interface In-Home Use Device: Brain Computer Interface for Wheelchair Tilt Control
Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.

Detailed Description:

In this study, people with Amyotrophic Lateral Sclerosis (ALS) will have a BCI in their home. They will receive training in order to operate and maintain the BCI. The BCI will allow them to access at least one task of primary interest to them. Task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. Data concerning the use of the BCI will be collected throughout the study.

  Eligibility

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

Inclusion Criteria:

  • Age 18 or older.
  • Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
  • Able to see the BCI display
  • Able to understand and remember instructions concerning participation.
  • Live in an environment that can accommodate the wheelchair portable BCI host computer
  • Expected to live in the same physical environment for at least 6 months.
  • Has family and caregiver(s) who are supportive of participation in this research.
  • Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months.
  • Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968).
  • Has a clear understanding of the shortcomings of the present state of BCI technology

Exclusion Criteria:

  • Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
  • Inability to communicate well enough to give informed consent.
  • History of photo-sensitive epilepsy
  • Known significant cognitive deficits
  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: NCT01123200

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jane Huggins, PhD University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Jane Huggins, PhD, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01123200     History of Changes
Other Study ID Numbers: J0002
Study First Received: May 4, 2010
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014