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OpenTrials
Completed

NCT Number: NCT06446037

Assessment of Gesture Accuracy of a Prosthesis Control System

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.

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Key information

Conditions

Upper Limb Amputation Below Elbow (Injury) Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Phantom Neuro Inc. Operational Headquarters

Austin, Texas, 78704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: EMG prosthesis control

Primary outcomes

  1. Gesture accuracy

    Time frame: Acute visit (at most 3 hours)

    Percentage of hand gestures accurately decoded by Phantom X algorithm

Sponsors and collaborators

Lead sponsor

Phantom Neuro Inc.

Industry

Registry information

Official study title

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

Acronym: ASCENT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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