NCT01123200

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

March 15, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

May 4, 2010

Results QC Date

January 12, 2017

Last Update Submit

March 14, 2017

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Duration of BCI Usage by Persons With ALS.

    Number of months of BCI usage by each participant.

    Monthly measurements for a period of up to 18 months.

Secondary Outcomes (1)

  • Changes in Accuracy of BCI for Controlling Devices and Text

    6 months, 12 months, 18 months

Study Arms (1)

Brain Computer Interface In-Home Use

OTHER
Device: Brain Computer Interface for Wheelchair Tilt Control

Interventions

Brain Computer Interface for Wheelchair Tilt ControlDEVICE

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.

Brain Computer Interface In-Home Use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Results Point of Contact

Title
Jane Huggins
Organization
University of Michigan
janeh@umich.edu
734-936-7177

Study Officials

  • Jane Huggins, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 14, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 15, 2017

Results First Posted

March 15, 2017

Record last verified: 2017-03

Locations

US(1)