Assessment of Gesture Accuracy of a Prosthesis Control System

Upper Limb Amputation Below Elbow (Injury) Clinical Trial

— ASCENT  

Official title:

Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446037
• Other study ID #: PN01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Phantom Neuro Inc.
• Contact: Vinod Sharma, PhD
• Phone: 763-350-2091
• Email: vinod[@]phantomneuro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.

Description:

The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Individuals 21 years in age and older

2. Individuals with amputation of one or both arms at transradial level (applies to amputees only)

3. Ability to follow study directions

4. Willingness and ability to sign Informed Consent

Exclusion Criteria:

1. Individuals with previously diagnosed muscle pathologies

2. Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)

3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only)

4. Cognitively impaired to follow study instructions

5. Allergies to skin adhesive materials necessary for cutaneous electrode placement

6. Excessive hair growth on arms and inability to shave off the hair for electrode placement

7. Pregnant woman

8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays

9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

Related Conditions & MeSH terms

• Upper Limb Amputation Below Elbow (Injury)

Intervention

Device:
• Non-invasive EMG band instrumentation
The sensed EMG signals from the subjects will be decoded by Phantom X algorithm and used to drive various gestures in a desk-mounted hand prosthesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phantom Neuro Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gesture accuracy	Percentage of hand gestures accurately decoded by Phantom X algorithm	Acute visit (at most 3 hours)