Evaluation of a Tongue Operated Assistive Technology for... | NCT01124292

ID	Type	Description	Link
1RC1EB010915-01	U.S. NIH Grant/Contract		View source

Name	Class
Shepherd Center, Atlanta GA	OTHER
Northwestern University	OTHER
Shirley Ryan AbilityLab	OTHER
University of Arizona

Description Module

Detailed Description

A new assistive neuro-technology (ANT), called the Tongue Drive System (TDS), enables individuals with severe disability access their environment with nothing but their tongue motion. The human tongue is inherently capable of sophisticated control and manipulation tasks with many degrees of freedom. It can move rapidly and accurately within the mouth such that the tip can touch every single tooth. The direct connection between the brain and the tongue generally allows it to escape damage even in severe spinal cord injuries (SCI). Unlike the brain, the tongue is accessible, and its location inside the mouth affords a degree of privacy.

TDS consists of a magnetic tracer, the size of a lentil, attached to the tongue by gluing, implantation, or piercing. The tracer generates a magnetic field inside and around the mouth that is detected by an array of magnetic sensors mounted on a wireless headset. Tongue-movement-induced changes in the magnetic field are sent wirelessly to an ultra-mobile computer or smartphone, carried by the user, which processes and translates every tongue motion to a particular user-defined function.

Once an individual with disability is "enabled" to access a computing device, he/she can nearly do everything that an able-bodied individual can do with that device. This includes communicating, education, training, entertainment, and controlling other devices such as powered wheelchairs (PWC), assistive robotic manipulators, and other home/office appliances on a local area network (LAN). Even the individual's own natural or prosthetic limbs can be manipulated to move by functional electrical stimulation (FES).

This study was intended to evaluate the TDS by the ultimate intended users, 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 life such as computer access, wheeled mobility, and environmental control.

Three groups of subjects were recruited:

Group-A: Able-bodied subjects who already have tongue piercing

Group-B: Able-bodied subjects who wanted to receive tongue piercing as part of this trial

Group-C: Subjects with high-level disability, who wanted to receive tongue piercing as part of this trial

Each group of subjects participated in a battery of tasks that quantitatively measures their performance in accessing computers and driving wheelchairs using the TDS.

We also devised acceptable procedures for receiving a magnetic tongue piercing (required in order to use the TDS), and assess its potential safety issues.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion group-A:

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

Inclusion group-B:

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

Inclusion group-C:

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)
Have some experience in using computers
Be able to move the tongue
Be able to speak or respond to questions by themselves or through an augmentative and alternative communication (AAC) device
Be able to give consent
Be able to have a caregiver, who can respond immediately in the event of an emergency, available during the period of the study.
Can understand and speak English
Have or are willing to receive a tongue piercing in the midline between the tip and the lingual frenulum, almost in the center of the mouth

Exclusion Criteria:

Exclusion Group-A:

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

Exclusion Group-B:

Tongue too short or the tongue web too far extended, making tongue piercing difficult
Have a torus mandibularis or palatini or other space-occupying intra-oral lesion or orthodontic appliance
No experience with computers or illiterate
Severe hearing or visual deficiency or impairing neurological disease
Cardiovascular and respiratory diseases, artificial heart valve, congenital heart disease
On an immunosuppressive medication or otherwise immunocompromised
Diabetic or have any other ongoing systemic condition deemed to be relevant by the local investigator-clinician
Ongoing neoplastic disease other than localized basal cell or squamous cell carcinoma of the skin
Have known asthma, physical urticaria or angioedema
Have any current infectious condition
Cognitive impairment to the extent that cannot follow simple commands
Is pregnant
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
Space occupying orthodontic appliances
Unable to come SCA or NU for a tongue piercing, 72 hour visit and to GTB 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

Exclusion Group-C:

Unable to move the tongue
Have a large object or tube in the mouth blocking tongue motion
Tongue or tongue frenulum short or the tongue frenulum extended far forward, making tongue piercing difficult
Have a torus mandibularis or palatini or other space-occupying intra-oral lesion or orthodontic appliance
Medically or mentally unstable
Known sensitivity or allergy to an adhesive
Using a halo brace or facial pads that would block the use of a headset or headgear
Cognitive impairment to the extent that the subject cannot follow simple commands
Severe hearing or visual deficiency
Cardiovascular and respiratory diseases, artificial heart valve, congenital heart disease
On any form of anticoagulation including but not limited to warfarin, heparin, low-molecular-weight heparin, factor Xa inhibitors, aspirin, aspirin-containing products, or nonsteroidal anti-inflammatory medications that the subject's supervising attending physician states cannot be stopped during the pre-piercing period which may include not only the appropriate medication-specific washout period before the piercing but also up to 5 days after the procedure.
On an immunosuppressive or otherwise immunocompromised
Have a decubitus ulcer stage III or higher or a decubitus ulcer of any stage that is worsening.
Diabetic or have any other ongoing systemic condition, as deemed to be relevant by the local investigator-clinician
Ongoing neoplastic disease other than localized basal cell or squamous cell carcinoma of the skin
Have known asthma, physical urticaria or angioedema
Have any current infectious condition
Is pregnant
No experience with computers or illiterate
Using a sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body
Unable to sit for 4 hours with pressure relief
Wounds or ulcers on the head or in the mouth or on the tongue
No continuous access to a caregiver
Unable to come to the SCA or NMH for a three day stay for tongue piercing and to SCA or RIC on a regular basis during the study-period
Miss more than three appointments without prior notification
Unable to comply with any of the procedures in the protocol

Name	Affiliation	Role
Maysam Ghovanloo, Ph.D.	Georgia Institute of Technology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Georgia Institute of Technology		Atlanta	Georgia	30308	United States
Shepherd Center

PubMed Identifier	Type	Citation	Retractions
20332552	Background	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.
19362901	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.

Label	URL
CNN report on the first clinical trial of the Tongue Drive System at the Shepherd Center in 2009	View source

ID	Title	Description
FG000	Able-bodied Subject With Tongue Piercing	Able-bodied subjects who already have tongue piercing.
FG001	Able-bodied Subject Without Tongue Piercing	Able-bodied subjects who willing to receive a tongue piercing for this study.
FG002	Subjects With Spinal Cord Injury	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.

ID	Title	Description
BG000	Able-bodied Subject With Tongue Piercing	Able-bodied subjects who already have tongue piercing.
BG001	Able-bodied Subject Without Tongue Piercing:	Able-bodied subjects who willing to receive a tongue piercing for this study.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Deviation

bits per second

24 months

ID	Title	Description
OG000	Able-bodied Subject With Tongue Piercing (Group-A)	Able-bodied subjects who already have tongue piercing.

ID	Term
D011782	Quadriplegia
D013119	Spinal Cord Injuries
D010243	Paralysis

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D046289	Body Modification, Non-Therapeutic
D003357	Cosmetic Techniques
D013812	Therapeutics
D013514	Surgical Procedures, Operative