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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124292
First Posted: May 17, 2010
Last Update Posted: September 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Shepherd Center, Atlanta GA
Northwestern University
Shirley Ryan AbilityLab
University of Arizona
Information provided by (Responsible Party):
Maysam Ghovanloo, Georgia Institute of Technology
Results First Submitted: May 2, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Quadriplegia
Spinal Cord Injury
ALS
Interventions: Procedure: Tongue Piercing
Device: Usability assessment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Able-bodied subjects (groups A and B) were recruited by using local IRB-approved flyers, emails, and electronically distributed documents.

Subjects with spinal cord injuries were recruited from the in- and outpatient departments of the Shepherd Center and the Rehabilitation Institute of Chicago.

(May. 2010 - March. 2012)


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Able-bodied Subject With Tongue Piercing Able-bodied subjects who already have tongue piercing.
Able-bodied Subject Without Tongue Piercing Able-bodied subjects who willing to receive a tongue piercing for this study.
Subjects With Spinal Cord Injury persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.

Participant Flow:   Overall Study
    Able-bodied Subject With Tongue Piercing   Able-bodied Subject Without Tongue Piercing   Subjects With Spinal Cord Injury
STARTED   16   24   21 
COMPLETED   14   9   11 
NOT COMPLETED   2   15   10 
Lost to Follow-up                2                4                3 
Physician Decision                0                3                2 
Withdrawal by Subject                0                6                2 
medical issue unrelated to the study                0                0                2 
piercing track closed                0                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Able-bodied Subject With Tongue Piercing Able-bodied subjects who already have tongue piercing.
Able-bodied Subject Without Tongue Piercing: Able-bodied subjects who willing to receive a tongue piercing for this study.
Subjects With Spinal Cord Injury Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Total Total of all reporting groups

Baseline Measures
   Able-bodied Subject With Tongue Piercing   Able-bodied Subject Without Tongue Piercing:   Subjects With Spinal Cord Injury   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   9   11   34 
Age 
[Units: Participants]
       
<=18 years   1   0   0   1 
Between 18 and 65 years   13   9   11   33 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.12  (4.85)   22.56  (4.00)   38.30  (10.25)   27.61  (9.72) 
Gender 
[Units: Participants]
       
Female   10   5   2   17 
Male   4   4   9   17 
Region of Enrollment 
[Units: Participants]
       
United States   14   9   11   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)   [ Time Frame: 24 months ]

2.  Primary:   Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)   [ Time Frame: 24 months ]

3.  Primary:   Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)   [ Time Frame: 24 months ]

4.  Primary:   Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)   [ Time Frame: 24 months ]

5.  Primary:   Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)   [ Time Frame: 24 months ]

6.  Primary:   Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)   [ Time Frame: 24 months ]

7.  Primary:   Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)   [ Time Frame: 24 months ]

8.  Primary:   Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)   [ Time Frame: 24 months ]

9.  Primary:   Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)   [ Time Frame: 24 months ]

10.  Primary:   Information Transfer Rate (ITR)   [ Time Frame: 24 months ]

11.  Primary:   Information Transfer Rate (Percentage of Correctly Completed Commands)   [ Time Frame: 24 months ]

12.  Primary:   On-screen Maze Using TDS, Keypad, and SnP (Completion Time)   [ Time Frame: 24 months ]

13.  Primary:   On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)   [ Time Frame: 24 months ]

14.  Primary:   Driving a Wheelchair Using TDS vs SnP (Completion Time)   [ Time Frame: 24 months ]

15.  Primary:   Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)   [ Time Frame: 24 months ]

16.  Primary:   Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)   [ Time Frame: 24 months ]

17.  Primary:   Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)   [ Time Frame: 24 months ]

18.  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.   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Maysam Ghovanloo
Organization: Georgia Institute of Technology
phone: 404-385-7048
e-mail: mgh@gatech.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maysam Ghovanloo, Georgia Institute of Technology
ClinicalTrials.gov Identifier: NCT01124292     History of Changes
Other Study ID Numbers: H09240
1RC1EB010915-01 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2010
First Posted: May 17, 2010
Results First Submitted: May 2, 2013
Results First Posted: September 10, 2013
Last Update Posted: September 18, 2013