Transradial Amputation, Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation
Conditions
Keywords
Upper limb amputation, Prosthesis, Myoelectric
Brief summary
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
DEVICEPhantom 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.
Sponsors
Phantom Neuro Inc.
Cabrini Health, Melbourne, Australia
ProMotion Prosthetics, Moorabbin, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter | 9 weeks | Safety is characterized by collecting device and procedure related adverse events during device implantation and 9-week study follow-up. |
| Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument | 9 weeks | Average and standard deviation of ACMC scores will be computed for all participants |
| Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument | 9 weeks | Average and standard deviation of tBBT scores will be computed for all participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter | 21 weeks | Safety is characterized by collecting device and procedure related adverse events during device implantation and 21-week study follow-up. |
| Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument | 21 weeks | Average and standard deviation of ACMC scores will be computed for all participants |
| Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument | 21 weeks | Average and standard deviation of tBBT scores will be computed for all participants |
| Phantom X Signal-to-Noise Ratio (SNR) | 9 weeks and 21 weeks | 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 |
| Phantom X algorithm gesture accuracy | 9 weeks and 21 weeks | 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 |
| Phantom X at-home wear duration | 9 weeks and 21 weeks | Average and standard deviation of at-home prosthesis wear duration for all participants will be computed |
| At-home limb usage pattern using Inertial Measurement Unit (IMU) data | 9 weeks and 21 weeks | Active and inactive durations in hours per day for each limb will be computed for each participant |
| Prosthesis control resolution | 9 weeks and 21 weeks | Resolution of Phantom X control system for controlling a myoelectric hand prosthesis will be characterized using Myoelectric Control Resolution Assessment (MCRA) instrument |
| Number of system recalibration events | 9 weeks and 21 weeks | Number of Phantom X recalibrations per participant will be collected and used to compute average and standard deviation of recalibration events for all participants |
| User Satisfaction | 9 weeks and 21 weeks | 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. |
| Robustness of Phantom X system | 9 weeks and 21 weeks | 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. |
| Phantom X ease of use | 9 weeks and 21 weeks | Ease of use and intuitiveness of Phantom X system is characterized using NASA-Task Load Index (NASA-TLX) instrument. |
| Phantom Limb Pain | 9 weeks and 21 weeks | Change in phantom limb pain is characterized post implant and compared with baseline using Questionnaire for Post-Amputation Pain (Q-PAP). |
Countries
Australia
Contacts
CONTACTVinod Sharma, PhD
PRINCIPAL_INVESTIGATORMichael Lo, MBBS, FRACS, BSc (Hons)
Cabrini Private Hospital, Malvern, Australia
Outcome results
None listed