Assessment of Gesture Accuracy of a Prosthesis Control System

Early Phase 1CompletedNCT06446037

Phantom Neuro Inc.11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Upper Limb Amputation Below Elbow (Injury)

Interventions

Non-invasive EMG band instrumentationDEVICE

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

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Phantom Neuro Inc. Operational Headquarters

Austin, Texas, United States

Outcomes

Primary Outcomes

Gesture accuracy

Percentage of hand gestures accurately decoded by Phantom X algorithm

Time frame: Acute visit (at most 3 hours)

Data from ClinicalTrials.gov

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