Phase 1
N=61
Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis
Quadriplegia · Spinal Cord Injury · ALS
Bottom Line
View on ClinicalTrials.gov: NCT01124292 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput) — 1.97; 2.03; 1.54; 2.04 bits per second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tongue Piercing (Procedure); Usability assessment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Georgia Institute of Technology
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput) |
1.97; 2.03; 1.54; 2.04; 2.22; 1.75 | — |
| PRIMARY Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate) |
29.14; 23.85; 37.84; 24.08; 18.36; 30.62 | — |
| PRIMARY Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput) |
2.14; 2.22; 1.44; 2.27; 2.54; 1.77 | — |
| PRIMARY Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate) |
26.16; 19.47; 38.95; 21.83; 15.88; 30.37 | — |
| PRIMARY Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput) |
0.83; 0.77; 0.37; 1.23; 0.96; 0.52 | — |
| PRIMARY Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate) |
37.65; 41.41; 61.98; 27.33; 32.61; 55.05 | — |
| PRIMARY Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time) |
1.70; 1.29; 4.00; 1.33; 1.22; 3.18 | — |
| PRIMARY Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput) |
0.40; 0.80; 0.39; 0.62; 0.93; 0.42 | — |
| PRIMARY Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate) |
32.67; 21.34; 54.91; 21.56; 14.27; 51.52 | — |
| PRIMARY Information Transfer Rate (ITR) |
74.33; 128.40; 66.68; 75.53; 146.34; 99.15 | — |
| PRIMARY Information Transfer Rate (Percentage of Correctly Completed Commands) |
98.62; 93.51; 73.87; 99.12; 98.15; 83.70 | — |
| PRIMARY On-screen Maze Using TDS, Keypad, and SnP (Completion Time) |
27.80; 23.36; 34.27; 16.61; 17.13; 28.71 | — |
| PRIMARY On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000) |
30.05; 23.59; 64.86; 4.51; 13.27; 41.86 | — |
| PRIMARY Driving a Wheelchair Using TDS vs SnP (Completion Time) |
198.17; 240.85; 253.45; 169.21; 194.93; 219.46 | — |
| PRIMARY Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors) |
2.67; 8.44; 8.76; 1.17; 6.59; 7.48 | — |
| PRIMARY Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time) |
187.69; 109.11; 89.99; 88.37; 89.37; 81.87 | — |
| PRIMARY Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time) |
116.19; 74.82; 78.24; 75.52; 74.46; 71.35 | — |
| PRIMARY Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks. |
2.57; 2.78; 2.91; 3.10; 4.07; 3.44 | — |
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
Data sourced from ClinicalTrials.gov (NCT01124292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.