Prosthesis Control System for Below Elbow Amputation

(ASCENT Trial)

Overseen By Vinod Sharma, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Phantom Neuro Inc.

Disqualifiers: Muscle pathologies, Impaired muscle function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Acute visit (at most 3 hours)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prosthesis control system called Phantom X. The goal is to evaluate how effectively Phantom X can control a hand prosthesis using muscle signals in individuals with a forearm amputation. Participants will have electrodes placed on their forearms to send muscle signals to Phantom X, which will then control a desk-mounted prosthetic hand. Suitable candidates have had a forearm amputation and can follow study directions. As an Early Phase 1 trial, this research aims to understand how Phantom X functions in people, offering participants the chance to be among the first to experience this innovative technology.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that the Phantom X prosthesis control system is safe?

Research shows that the safety of the Phantom X prosthesis control system remains under investigation. This early-phase trial marks the beginning of testing the treatment's safety in people. Initial results are not yet available, but early-phase trials typically aim to determine if a new treatment is safe and tolerable for participants.

Previous research on similar prosthesis systems has highlighted the importance of user safety and comfort. However, specific information on any side effects or problems with Phantom X is not yet available. Currently, the focus is on ensuring that the system's technology, which reads muscle signals to control a prosthetic hand, operates smoothly and safely. Participants in similar studies have found that these systems can significantly improve control and function, but specific safety details for Phantom X are still under review. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most prosthetic solutions for below elbow amputation rely on mechanical or simple myoelectric control, which can feel unnatural or limited. Phantom X is unique because it uses an advanced electrode array placed on the forearm to capture electromyographic (EMG) signals. These signals are then decoded by Phantom X's sophisticated algorithms to control a prosthetic hand in a more intuitive and responsive way. Researchers are excited about Phantom X because it offers the potential for more natural movement and improved functionality, which could significantly enhance the daily lives of users.

What evidence suggests that the Phantom X prosthesis control system is effective for below elbow amputation?

Research has shown that the Phantom X system, used by participants in this trial, helps control a prosthetic hand through muscle signals from the arm. Studies have found that natural arm movements can simplify the control of prosthetic limbs. This allows users to move their prosthetic hand in a more natural and coordinated manner. Early signs suggest that this type of control can enhance the functionality of prosthetic devices for individuals with below-elbow amputations. Although detailed human data remains limited, the promising use of muscle signals to operate prosthetics supports its potential effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 21 who can follow instructions and consent to participate. It's specifically for those with an amputation below the elbow, as well as able-bodied individuals, to test a new prosthesis control system called Phantom X.

Inclusion Criteria

I am 21 years old or older.

I can follow the study's instructions.

I am willing and able to sign the Informed Consent document.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are instrumented with an electrode array on their forearms to evaluate the performance of the Phantom X system

Acute visit (at most 3 hours)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Phantom X

Trial Overview The study tests Phantom X, a non-invasive EMG band-based prosthesis control system designed to improve gesture accuracy for individuals with forearm-level amputations.

How Is the Trial Designed?

Group I: Interventional arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Phantom Neuro Inc.

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. withpower.com withpower.com/trial/phase-upper-limb-amputation-below-elbow-6-2025-65fb4

Phantom X for Below Elbow Amputation (EMPOWER Trial) This study tests how well the Phantom X prosthesis control system works. The system helps control a prosthetic hand using muscle signals from the arm.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07032753?aggFilters=status%3A

Neuromusculoskeletal Interface for Bionic Arms The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10581689/

Intuitive movement-based prosthesis control enables arm ... We designed an intuitive, movement-based prosthesis control that leverages natural arm coordination to predict distal joints missing in people with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666138123000130

X-reality for phantom limb management for amputees X-reality can significantly relieve phantom pain despite heterogeneity in studies. Themes included motor control, skills training, and stimulus-sensing.

5. nature.com nature.com/articles/s41598-018-33643-0

Characteristics of phantom upper limb mobility encourage ... Five above-elbow amputees participated in a PLM training program and consequently increased both endurance and speed of their PLM. These results ...

6. withpower.com withpower.com/trial/early-phase-1-upper-limb-amputation-below-elbow-injury-5-2024-faac2

Prosthesis Control System for Below Elbow Amputation The ASCENT medical study, being run by Phantom Neuro Inc., needs participants to evaluate whether Phantom X will have tolerable side effects & efficacy for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9636812/

A review of user needs to drive the development of lower ... The perception of safety while using a prosthesis is reported as the most important need, which is independent of the mobility level of the ...

8. mdpi.com mdpi.com/2673-1592/6/2/22

Upper Limb Prostheses by the Level of Amputation This review covers upper limb prostheses for transmetacarpal, transcarpal, transradial, and transhumeral amputations, analyzing control, ...