Neural Enabled Prosthesis for Upper Limb Amputees
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|ClinicalTrials.gov Identifier: NCT03432325|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amputation Arm and Hand, Unilateral Right Amputation Arm and Hand, Unilateral Left Prosthesis User||Device: Neural Enabled Prosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Neural Enabled Prosthesis for Upper Limb Amputees|
|Actual Study Start Date :||December 14, 2017|
|Estimated Primary Completion Date :||September 29, 2023|
|Estimated Study Completion Date :||September 29, 2023|
Experimental: Neural Enabled Prosthesis
Neural Enabled Prosthesis Treatment Group
Device: Neural Enabled Prosthesis
Surgically implanted neural enabled prosthesis
- Safety of the Neural Stimulation System [ Time Frame: Up to 104 weeks - post-treatment ]Documented as the number of treatment-related adverse events as assessed by CTCAE v4.0.
- Efficacy: Functionality of implanted system components [ Time Frame: Up to 104 weeks - post-treatment ]Documented as the percentage of implanted electronic units fully operational and the percentage of electrodes intact (having measured impedance values < OR = 30kΩ)
- Efficacy: Elicited sensations [ Time Frame: Up to 104 weeks - post-treatment ]Ability of the system to elicit graded sensations documented as the correlation between stimulation intensity (expressed as a percentage of the stimulation range) and reported intensity of the elicited sensation (expressed as a percentage of the range of elicited sensations)
- Efficacy: Graded control [ Time Frame: Up to 104 weeks - post-treatment ]The ability of the system to enable graded control of a prosthesis measured as the accuracy with which the subject can achieve a specified target level of grasp force or hand opening. Comparing performance with & without sensory stimulation
- Efficacy: Activity Measure for Upper Limb Amputees (AM-ULA) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]The ability of the system to facilitate completion of functional tasks documented by using the AM-ULA. Comparing performance with & without sensory stimulation
- Clinical Surveys: Orthotics and Prosthetics User Survey - The Upper Extremity Functional Status (OPUS - UEFS) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]The UEFS is a 28-item self-report pertaining to an individual's performance of self-care and daily living skills using the prosthetic hand. UEFS has a 5-point Likert scale where Score Points are 0 = not able, 1 = difficult, 2 = easy, 3 = very easy scores are given. The survey will be used to document changes in participants' functional status and quality of life.
- Clinical Surveys: Disabilities of the Arm, Shoulder, and Hand (DASH) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]The DASH Outcome Measure is a 30-item (scored 1-5) self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The survey will be used to measure disability of the upper extremities, and monitor change or function over time.
- Clinical Surveys: Trinity Amputation and Prosthetics Experience Scales - Revised (TAPES-R) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]This outcome measure is a 54-item self-report, health-related QOL questionnaire. This survey will be used to measure psychosocial processes that are linked with adapting to a prosthesis, to the activity restrictions associated with wearing a prosthesis, and to satisfaction with the prosthesis. Only some sections of the complete version have been included in the survey documents. In specific, we will administer the Psychosocial Scale (15 items) and Satisfaction with the Prosthesis Scale (8 items).
- Clinical Surveys: Groningen Questionnaire - Problems After Arm Amputation (GQ-PAAA) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]The GQ_PAAA is a 14-item self-report measurement. This survey will be used to document frequency of phantom limb sensation, phantom limb pain, and stump pain. A modified version of this measure has been included in the survey documents.
- Clinical Surveys: 12-Item Short Form Survey (SF-12) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]This outcome measure is a 12-item self-report questionnaire that provides glimpses into mental and physical functioning and overall health-related-quality of life. This survey will be used to document health-related quality of life.
- Clinical Surveys: McGill Pain Questionnaire (MPQ) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]This survey will be used to document the quality and intensity of pain that the participant is experiencing. Participants select a single word from each of the 20 groups and then describe their present pain intensity on a scale of 0 to 5.
- Clinical Assessment: Adaptive Neural Systems - Phantom Limb Telescoping Assessment (ANS-PLTA) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]We have developed this assessment to measure the phantom limb telescoping at the beginning and at the end of each session to track how the length of the phantom limb changes after stimulation within a session and across sessions as reported by the subject. Subjects report where the end of the phantom limb is by pointing at it with the other hand.
- Clinical Assessment: The Southampton Hand Assessment Procedure (SHAP) [ Time Frame: Baseline plus up to 104 weeks post-treatment ]SHAP is a clinically validated hand function test developed to assess the effectiveness of upper limb prostheses. The SHAP is made up of 6 abstract objects and 14 Activities of Daily Living (ADL). Each task is timed by the subject and recorded on an assessment sheet by the assessor.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432325
|Contact: Clinical Research Coordinator||(305) 348-4782||ANSlab@fiu.edu|
|United States, Florida|
|Florida International University||Recruiting|
|Miami, Florida, United States, 33174|
|Contact: Clinical Research Coordinator 305-348-4782 ANSlab@fiu.edu|
|Principal Investigator: Ranu Jung, Ph.D.|