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

Completed · Phase 1

Conditions studied: Quadriplegia, Spinal Cord Injury, ALS

In brief

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.

Key facts

Study ID

NCT01124292

Run by

Georgia Institute of Technology

People needed

61

Starts

2010-05-01

Expected to finish

2012-03-01

Last updated by the study team

2013-09-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgia Institute of Technology — Atlanta, Georgia, United States
• Shepherd Center — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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