Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis (TDS-1)

This is an interventional supportive care trial for Quadriplegia focused on measuring Disability, Quadriplegia, Paralysis, Assistive technology, Quality of life, Computer access, Wheeled mobility Read More

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