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CompletedNCT06446037ASCENTUpdated Jun 4, 2025

Assessment of Gesture Accuracy of a Prosthesis Control System

An Early Phase 1 interventional study of Non-invasive EMG band instrumentation in Upper Limb Amputation Below Elbow (Injury), sponsored by Phantom Neuro Inc.. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Phantom Neuro Inc. · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Upper Limb Amputation Below Elbow (Injury)

Keywords

  • Prosthesis
  • Upper limb amputee
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In context

Lead sponsor

Phantom Neuro Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Interventional arm

    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

  • DeviceNon-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

    Also known as: EMG prosthesis control

06

What researchers measure

Primary outcomes

  1. Gesture accuracy

    Percentage of hand gestures accurately decoded by Phantom X algorithm

    Time frame: Acute visit (at most 3 hours)

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Study locations

1 site
  • Phantom Neuro Inc. Operational Headquarters
    Austin, Texas 78704, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06446037
Lead sponsor
Phantom Neuro Inc.
Responsible party
Sponsor
First posted
Jun 6, 2024
Start date
Aug 13, 2024
Primary completion
Apr 18, 2025
Completion
Apr 18, 2025
Last update
Jun 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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