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

NCT01124292 | Completed Phase 1 Results DMC

• 2 other identifiers: H092401RC1EB010915-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Disability; Quadriplegia; Paralysis; Assistive technology; Quality of life; Computer access; Wheeled mobility

Outcome Measures

Primary Outcomes (18)

• Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)

  Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Information Transfer Rate (ITR)

  Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B \&-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Information Transfer Rate (Percentage of Correctly Completed Commands)

  Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B \&-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• On-screen Maze Using TDS, Keypad, and SnP (Completion Time)

  Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)

  Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Driving a Wheelchair Using TDS vs SnP (Completion Time)

  An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A\&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.

  24 months

• Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)

  An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A\&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.

  24 months

• Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)

  Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored "CALL" button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)

  The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

  24 months

• Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.

  Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective

  24 months

Study Arms (3)

Able-bodied subject with piercing

EXPERIMENTAL

Able-bodied subjects who already have tongue piercing.

Device: Usability assessment

Able-bodied subject without piercing

EXPERIMENTAL

Able-bodied subjects who willing to receive a tongue piercing for this study.

Procedure: Tongue Piercing; Device: Usability assessment

Subjects with spinal cord injury

EXPERIMENTAL

Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.

Procedure: Tongue Piercing; Device: Usability assessment

Interventions

Tongue Piercing PROCEDURE

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.

Able-bodied subject without piercing; Subjects with spinal cord injury

Usability assessment DEVICE

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.

Able-bodied subject with piercing; Able-bodied subject without piercing; Subjects with spinal cord injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Able-bodied with a tongue piercing Must have had the tongue piercing for at least 3 months and still be using it
• Piercing is located in the midline of the tongue between the tip and the frenulum, almost in the center of the mouth
• Can understand and speak English
• Have some experience in using computers
• Age 18-65
• No overt sign of disability or neurological disease
• Do not have a tongue piercing, but are willing to receive one in the midline between the tip and lingual frenulum, almost in the center of the mouth
• Can understand and speak English
• Have some experience in using computers
• Age 18-65
• Have mobility limitations requiring a power wheel chair and also have inadequate upper limb strength to manage a hand or arm control i.e. have severe motor disabilities and need alternative control
• Either using or suitable for an alternative control
• Able to follow simple commands
• Sitting tolerance of at least 4 hours (each experiment session will be no more than 4 hours and the researcher follows the standard pressure relief schedule)

You may not qualify if:

• Original tongue piercing and the insertion site is too wide.
• Ongoing difficulties with current tongue jewelry
• Tongue piercing not located in the correct position on the tongue
• No experience with computers or illiterate
• Severe hearing or visual deficiency or impairing neurological disease
• Have any ongoing systemic condition deemed to be relevant by the local investigator-clinician
• Is pregnant
• Cognitive impairment so that unable to follow simple commands
• Wounds or ulcers on the head or in the mouth or on the tongue
• Using sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body
• Intra-oral space occupying lesion or orthodontic appliance
• Unable to come to GT or RIC on a regular basis during the study-period
• Miss more than two appointments without prior notification
• Unable to comply with any of the procedures in the protocol
• Tongue too short or the tongue web too far extended, making tongue piercing difficult

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• Shepherd Center, Atlanta GA: collaborator
• Northwestern University: collaborator
• Shirley Ryan AbilityLab: collaborator
• University of Arizona: collaborator

Study Sites (4)

Georgia Institute of Technology

Atlanta, Georgia, 30308, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

• Huo X, Ghovanloo M. Evaluation of a wireless wearable tongue-computer interface by individuals with high-level spinal cord injuries. J Neural Eng. 2010 Apr;7(2):26008. doi: 10.1088/1741-2560/7/2/026008. Epub 2010 Mar 23.

  PMID: 20332552 BACKGROUND

• Huo X, Ghovanloo M. Using unconstrained tongue motion as an alternative control mechanism for wheeled mobility. IEEE Trans Biomed Eng. 2009 Jun;56(6):1719-26. doi: 10.1109/TBME.2009.2018632. Epub 2009 Apr 7.

  PMID: 19362901 BACKGROUND

• Huo X, Wang J, Ghovanloo M. Introduction and preliminary evaluation of the Tongue Drive System: wireless tongue-operated assistive technology for people with little or no upper-limb function. J Rehabil Res Dev. 2008;45(6):921-30. doi: 10.1682/jrrd.2007.06.0096.

  PMID: 19009478 BACKGROUND

• Huo X, Wang J, Ghovanloo M. A magneto-inductive sensor based wireless tongue-computer interface. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):497-504. doi: 10.1109/TNSRE.2008.2003375.

  PMID: 18990653 BACKGROUND

• Huo X, Ghovanloo M. Using speech recognition to enhance the Tongue Drive System functionality in computer access. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6393-6. doi: 10.1109/IEMBS.2011.6091578.

  PMID: 22255801 BACKGROUND

• Yousefi B, Huo X, Veledar E, Ghovanloo M. Quantitative and comparative assessment of learning in a tongue-operated computer input device. IEEE Trans Inf Technol Biomed. 2011 Sep;15(5):747-57. doi: 10.1109/TITB.2011.2158608. Epub 2011 Jun 7.

  PMID: 21652288 RESULT

• Yousefi B, Huo X, Kim J, Veledar E, Ghovanloo M. Quantitative and comparative assessment of learning in a tongue-operated computer input device--part II: navigation tasks. IEEE Trans Inf Technol Biomed. 2012 Jul;16(4):633-43. doi: 10.1109/TITB.2012.2191793. Epub 2012 Jun 6.

  PMID: 22692932 RESULT

• Kim J, Huo X, Minocha J, Holbrook J, Laumann A, Ghovanloo M. Evaluation of a smartphone platform as a wireless interface between tongue drive system and electric-powered wheelchairs. IEEE Trans Biomed Eng. 2012 Jun;59(6):1787-96. doi: 10.1109/TBME.2012.2194713. Epub 2012 Apr 16.

  PMID: 22531737 RESULT

• Minocha JS, Holbrook JS, West DP, Ghovanloo M, Laumann AE. Development of a tongue-piercing method for use with assistive technology. JAMA Dermatol. 2014 Apr;150(4):453-4. doi: 10.1001/jamadermatol.2013.7165. No abstract available.

  PMID: 24284925 DERIVED

Related Links

• CNN report on the first clinical trial of the Tongue Drive System at the Shepherd Center in 2009
• Tongue Drive System featured on the Science Nation (the National Science Foundation online Magazine), showing a short video clip of the first clinical trial at the Shepherd Center in Atlanta.

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries; Paralysis

Interventions

Body Piercing

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Maysam Ghovanloo
• Organization: Georgia Institute of Technology

mgh@gatech.edu

404-385-7048

Study Officials

• Maysam Ghovanloo, Ph.D.

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Processor

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 18, 2013
• Results First Posted: September 10, 2013

Record last verified: 2013-09

Locations

US (4)