NCT02169375

Brief Summary

Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. The investigators want the BCIs to be more universal, and not depend on knowing the target location. Therefore, the investigators will test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 16, 2014

Last Update Submit

June 18, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of a mu rhythm BCI using adaptation versus no adaptation.

    Accuracy with which subjects can select one of two targets after a 3-second time period. The accuracy for a run is calculated as the % of the trials in which the correct target is selected. The average accuracy will be calculated for each of the 10 usage sessions and changes over the sessions will be tracked.

    10 times over 5 weeks

Study Arms (2)

Mu Rhythm with adaptation

EXPERIMENTAL
Other: Brain computer Interface Mu (SMR) rhythm

Mu Rhythm without adaptation

EXPERIMENTAL
Other: Brain computer Interface Mu (SMR) rhythm

Interventions

Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 10 sessions.

Mu Rhythm with adaptationMu Rhythm without adaptation

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older.
  • Able to read text on a computer screen
  • Able to understand and remember instructions concerning participation.

You may not qualify if:

  • Unable give informed consent.
  • Unable to understand and follow instructions.
  • Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
  • Known to have photosensitive epilepsy.
  • Open head lesions or sores.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Jane Huggins, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 23, 2014

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations