Assessment of Gesture Accuracy of a Prosthesis Control System

NCT06446037 | Completed Early Phase 1

• 1 other identifier: PN01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Limb Amputation Below Elbow (Injury)

Keywords

Prosthesis; Upper limb amputee

Outcome Measures

Primary Outcomes (1)

• Gesture accuracy

  Percentage of hand gestures accurately decoded by Phantom X algorithm

  Acute visit (at most 3 hours)

Study Arms (1)

Interventional arm

EXPERIMENTAL

All subjects will be instrumented with an electrode array on their forearms. The EMG signals detected by the electrodes will be fed into Phantom X hardware running the Phantom X algorithms. The algorithms will decode the EMGs signals and drive a desk mounted hand prosthesis.

Device: Non-invasive EMG band instrumentation

Interventions

Non-invasive EMG band instrumentation DEVICE

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

Also known as: EMG prosthesis control

Interventional arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 21 years in age and older
• Individuals with amputation of one or both arms at transradial level (applies to amputees only)
• Ability to follow study directions
• Willingness and ability to sign Informed Consent

You may not qualify if:

• Individuals with previously diagnosed muscle pathologies
• 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)
• Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
• Cognitively impaired to follow study instructions
• Allergies to skin adhesive materials necessary for cutaneous electrode placement
• Excessive hair growth on arms and inability to shave off the hair for electrode placement
• Pregnant woman
• Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
• Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

Sponsors & Collaborators

• Phantom Neuro Inc.: lead

Study Sites (1)

Phantom Neuro Inc. Operational Headquarters

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 6, 2024
• Study Start: August 13, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)