Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control (CYBORG)

Clinical Evaluation of System for Bionic Arm Gesture Control (CYBORG)

The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses. The study will assess surgical feasibility, device function, signal quality, and the system's ability to support intuitive prosthetic control during functional tasks. Participants will undergo implantation of the Phantom X sensors and complete a series of in-clinic visits to assess functional performance of the Phantom X system. Patient-reported outcomes will also be collected at various timepoints.

Study Overview

• Status: Not yet recruiting
• Conditions: Transradial Amputation; Upper Limb Amputation Below Elbow (Injury); Wrist Disarticulation
• Intervention / Treatment: Device: Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control

Detailed Description

This early-feasibility study will evaluate the safety and functional performance of the Phantom X Implantable EMG Sensor System in individuals with unilateral transradial amputation and wrist disarticulation. The system consists of an implanted EMG sensor array, an implanted telemetry module, and an external wearable interface that provides real-time muscle signals to a myoelectric prosthesis.

The study follows a prospective, single-arm, open label design. Participants will undergo surgical implantation followed by device activation, calibration, and integration with a compatible prosthetic hand. Study procedures include periodic assessments of EMG signal quality, standardized functional assessments, and patient reported outcomes including quality of life measures and user experience. Safety will be monitored through adverse-event reporting and system performance checks.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinod Sharma, PhD; Phone Number: +1 512-763-0152; Email: vinod@phantomneuro.com

Study Locations

• Australia
  • Victoria
    • Malvern, Victoria, Australia, 3189
      • Cabrini Health Ltd
      • Contact: Michael Lo, MBBS, FRACS, BSc (Hons); Phone Number: +61 039-509-7802; Email: mlo@bigpond.net.au
    • Moorabbin, Victoria, Australia, 3189
      • ProMotion Prosthetics Pty Ltd
      • Contact: Michael Lo, MSc, Dip.App.Sci; Phone Number: +61 039-532-5098; Email: davidlg@pmprosthetics.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient has a unilateral upper-limb difference (congenital or acquired) at the transradial or wrist level.
2. The patient currently uses a myoelectric prosthesis or is deemed a suitable candidate for fitting with a myoelectric prosthesis.
3. Patient is a suitable candidate for the implantation of the Phantom X sensor array as assessed by the implanting physician.
4. Patient is at least 18 years old and can provide written informed consent.
5. Patient is willing to comply with study protocol and make required study visits.
6. Patient received amputation ≥ 12 months prior to consent.

Exclusion Criteria:

1. Patient has a significant cognitive deficit resulting in inability to follow study directions.
2. Patient has a neuro-muscular deficit and is unable to initiate substantial muscle contraction in the residual limb as determined by the implanting physician or investigator.
3. Patient has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
4. The patient has a planned medical procedure (e.g., surgery) during the study period that could interfere with compliance with study visits or assessments.
5. Patient has an allergy to anesthesia or other medication used for sedation in the study.
6. Patient has an active implantable device (e.g. cardiac pacemaker, neuromodulation device) that can potentially interfere with the performance of Phantom X system.
7. Patient may require an MRI during the study duration.
8. Implantation of the device poses a health risk to the patient as determined by the implanting physician.
9. Women who are breastfeeding, currently pregnant or planning to become pregnant during the duration of the study or have a positive urine pregnancy test at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phantom X	Device: Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control; Participants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter	Safety is characterized by collecting device and procedure related adverse events during device implantation and 9-week study follow-up.	9 weeks
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument	Average and standard deviation of ACMC scores will be computed for all participants	9 weeks
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument	Average and standard deviation of tBBT scores will be computed for all participants	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter	Safety is characterized by collecting device and procedure related adverse events during device implantation and 21-week study follow-up.	21 weeks
Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument	Average and standard deviation of ACMC scores will be computed for all participants	21 weeks
Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument	Average and standard deviation of tBBT scores will be computed for all participants	21 weeks
Phantom X Signal-to-Noise Ratio (SNR)	Characterize signal-to-noise ratio (SNR) of electromyography (EMG) signals obtained using Phantom X system. Average and standard deviation of SNR for all participants will be computed	9 weeks and 21 weeks
Phantom X algorithm gesture accuracy	Classification accuracy of the Phantom X algorithm will be computed based on the number of correctly and incorrectly classified gestures and reported as a percentage	9 weeks and 21 weeks
Phantom X at-home wear duration	Average and standard deviation of at-home prosthesis wear duration for all participants will be computed	9 weeks and 21 weeks
At-home limb usage pattern using Inertial Measurement Unit (IMU) data	Active and inactive durations in hours per day for each limb will be computed for each participant	9 weeks and 21 weeks
Prosthesis control resolution	Resolution of Phantom X control system for controlling a myoelectric hand prosthesis will be characterized using Myoelectric Control Resolution Assessment (MCRA) instrument	9 weeks and 21 weeks
Number of system recalibration events	Number of Phantom X recalibrations per participant will be collected and used to compute average and standard deviation of recalibration events for all participants	9 weeks and 21 weeks
User Satisfaction	User Satisfaction with Phantom X system is characterized using following three standardized instruments: modified version of Orthotics Prosthetics User Survey (mOPUS, range: 0-100, Higher score is better), 5-level Quality of Life questionnaire (EQ-5D-5L, Higher score is better), Canadian Occupational Performance Measure (COPM, range:1-10, Higher score is better), and a study User Satisfaction Survey.	9 weeks and 21 weeks
Robustness of Phantom X system	Robustness of Phantom X system is characterized by recording problematic activities of daily living (REC-ADL) that participants have problem performing with their baseline myoelectric control system.	9 weeks and 21 weeks
Phantom X ease of use	Ease of use and intuitiveness of Phantom X system is characterized using NASA-Task Load Index (NASA-TLX) instrument.	9 weeks and 21 weeks
Phantom Limb Pain	Change in phantom limb pain is characterized post implant and compared with baseline using Questionnaire for Post-Amputation Pain (Q-PAP).	9 weeks and 21 weeks

Collaborators and Investigators

• Sponsor: Phantom Neuro Inc.
• Collaborators: Cabrini Health, Melbourne, Australia; ProMotion Prosthetics, Moorabbin, Australia
• Investigators: Principal Investigator: Michael Lo, MBBS, FRACS, BSc (Hons), Cabrini Private Hospital, Malvern, Australia

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Prosthesis; Myoelectric; Upper limb amputation
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PN03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We may not share IPD because of concerns about protecting participants' privacy and confidentiality. Even though our participant data would be de-identified, there is a risk (especially with sensitive, rare, or detailed clinical data as would be the case for amputees in our study) that the individuals could be re-identified. Maintaining confidentiality and minimizing potential harm to participants may outweigh the benefits of data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes