An In-home Study of Brain Computer Interfaces to Operate Wheelchair Tilt

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01123200
First received: May 4, 2010
Last updated: May 11, 2010
Last verified: January 2010
  Purpose

The investigators are working on 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, such as a power wheelchair. In this study, patients with Amyotrophic Lateral Sclerosis (ALS) will be able to control the tilt feature of their power wheelchair using only brainwaves, allowing for independent control.


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 to Operate Wheelchair Tilt

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Duration of BCI usage by patients with ALS. [ Time Frame: On average, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Brain Computer Interface Tilt Control 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.

  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.
  • Uses a power wheelchair with a power tilt/recline system.
  • Presently having difficulty operating the controls on the tilt/recline system or likely to have difficulty in the next six months.
  • Uses his/her power wheelchair at least 3 hours per day.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123200

Contacts
Contact: Mary Burton, MS 734-764-1454 umdbi-recruit@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mary Burton, MS    734-936-7178    umdbi-recruit@umich.edu   
Principal Investigator: Jane Huggins, PhD         
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, R21HD054913
Study First Received: May 4, 2010
Last Updated: May 11, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
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 April 17, 2014