Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis

Summary

This study was intended to evaluate a new assistive neuro-technology, known as the Tongue Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that are important in daily lives of these individuals, such as computer access, wheeled mobility, and environmental control.

Conditions

• Quadriplegia
• Spinal Cord Injury
• ALS

Interventions

PROCEDURE

Tongue Piercing

Subjects brush their teeth, and then swish and spit with chlorhexidine mouthwash for 30-60s. Subjects would be placed in a semirecumbent position in a procedure chair. After marking the piercing site using a sterilized surgical marking pen the protruded tongue would be pierced. Anesthesia may be used during the piercing at the discretion of the operator and the subject. A sterilized titanium or surgical grade stainless steel piercing tongue stud would be placed in an appropriate position on the tongue to minimize complications from the piercing but also facilitate good functionality of the TDS.

DEVICE

Usability assessment

Computer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22" LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance. Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions.

Sponsors & Collaborators

• Shepherd Center, Atlanta GA

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Shirley Ryan AbilityLab

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Georgia Institute of Technology

  lead OTHER

Principal Investigators

• Maysam Ghovanloo, Ph.D. · Georgia Institute of Technology

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2012-03-31

Completion

2012-03-31

Countries

• United States

Study Locations