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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter [Time frame: 9 weeks]
• Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument [Time frame: 9 weeks]
• Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument [Time frame: 9 weeks]

Secondary outcome measures (12)

• Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter [Time frame: 21 weeks]
• Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument [Time frame: 21 weeks]
• Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument [Time frame: 21 weeks]
• Phantom X Signal-to-Noise Ratio (SNR) [Time frame: 9 weeks and 21 weeks]
• Phantom X algorithm gesture accuracy [Time frame: 9 weeks and 21 weeks]
• Phantom X at-home wear duration [Time frame: 9 weeks and 21 weeks]
• At-home limb usage pattern using Inertial Measurement Unit (IMU) data [Time frame: 9 weeks and 21 weeks]
• Prosthesis control resolution [Time frame: 9 weeks and 21 weeks]
• Number of system recalibration events [Time frame: 9 weeks and 21 weeks]
• User Satisfaction [Time frame: 9 weeks and 21 weeks]
• Robustness of Phantom X system [Time frame: 9 weeks and 21 weeks]
• Phantom X ease of use [Time frame: 9 weeks and 21 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Patient has a significant cognitive deficit resulting in inability to follow study directions.
• 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.
• 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.
• The patient has a planned medical procedure (e.g., surgery) during the study period that could interfere with compliance with study visits or assessments.
• Patient has an allergy to anesthesia or other medication used for sedation in the study.
• Patient has an active implantable device (e.g. cardiac pacemaker, neuromodulation device) that can potentially interfere with the performance of Phantom X system.
• Patient may require an MRI during the study duration.
• Implantation of the device poses a health risk to the patient as determined by the implanting physician.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Australia · 2 centers

• Cabrini Health Ltd — Malvern
• ProMotion Prosthetics Pty Ltd — Moorabbin

Identifiers

NCT: NCT07325708 · PN03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗