Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis
Condition: Quadriplegia; Spinal Cord Injury; ALS
MeSH terms: Spinal Cord Injuries; Quadriplegia
Intervention: Tongue Piercing; Usability assessment
Intervention description: 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.; 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Disability; Quadriplegia; Paralysis; Assistive technology; Quality of life; Computer access; Wheeled mobility

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.
    

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