Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01124292
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01124292
Study Brief:
Protocol Section:
NCT01124292