Phantom X for Below Elbow Amputation

(EMPOWER Trial)

Not yet recruiting at 1 trial location

Overseen By Vinod Sharma, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Phantom Neuro Inc.

Disqualifiers: Cognitive impairment, Allergies, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called Phantom X, a cutaneous prosthesis control system that uses muscle signals from the arm to control a prosthetic hand. Participants will use the system in a clinic for one day, practicing hand movements and completing simple tasks. The goal is to evaluate how well the Phantom X system performs compared to their current prosthesis. Individuals with an amputation below the elbow who can wear a prosthetic hand might be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research and potentially enhance prosthetic technology.

Do I need 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.

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

Research has shown that the Phantom X prosthesis control system offers a new way to control a prosthetic hand using muscle signals from the arm. Although specific safety data from past studies on this exact system is not available, the trial is in an early testing stage. This stage involves checking basic safety and effectiveness.

In similar prosthetic technologies, early tests often assess how well users can operate the device without issues, including any discomfort or skin irritation from wearing it. Since the Phantom X system does not require surgery or internal placement, it presents fewer safety concerns compared to more invasive methods. However, this remains an exploratory stage, focusing on the system's functionality and user comfort. Participants will wear it for only one day, reducing the risk of any long-term issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cutaneous Prosthesis Control System, part of the Phantom X system, is unique because it offers a more intuitive and natural way for individuals with below-elbow amputations to control their prosthetic devices. Unlike traditional prosthetics that rely on mechanical or myoelectric control, this system uses a cutaneous interface, which may provide more precise and responsive movements. Researchers are excited because this could significantly improve user satisfaction and functionality, making prosthetic use feel more like a natural extension of the body.

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

Research shows that the Phantom X prosthesis control system can use muscle signals from the arm to operate a prosthetic hand. Early results suggest this helps users perform tasks more naturally and comfortably. Studies have found that similar systems boost user satisfaction and improve control and skills training. In this trial, participants will use the cutaneous version of the Phantom X system, which aims to offer better control and a more intuitive experience for people with below-elbow amputations. Although specific data on the Phantom X system's performance is still being gathered, early signs are promising for improving prosthetic hand function. ^{1 6 7 8 9}

Who Is on the Research Team?

Elad Levy, MD

Principal Investigator

Atlas Ambulatory Surgery Center, Buffalo, NY

Are You a Good Fit for This Trial?

This trial is for individuals with an amputation below the elbow who currently use a prosthetic hand. Participants will test a new prosthesis control system called Phantom X, which uses muscle signals to operate.

Inclusion Criteria

I am 21 years old or older.

I have had one or both of my arms amputated at or below the elbow.

I am willing to follow the study rules and attend all required visits.

Exclusion Criteria

Allergies to skin adhesive materials necessary for cutaneous electrode placement

Pregnant woman

Residual limbs of insufficient diameter or length to accommodate the wearing of two cutaneous sensor arrays

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants are fitted with the Phantom X system and perform functional assessments

1 day

1 visit (in-person)

Follow-up

Participants complete user satisfaction and intuitiveness questionnaires

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cutaneous Prosthesis Control System

Trial Overview The study evaluates the effectiveness of the Phantom X prosthesis control system in performing real-world tasks. Participants will compare their usual prosthetic hand with this new system during one day of clinic tests and surveys.

How Is the Trial Designed?

Group I: Participants instrumented with cutaneous version of Phantom X system using a universal socket Experimental Treatment 1 Intervention

With Phantom X system instrumented, participants will perform the following two assessments: ACMC and tBBT. They will also complete user satisfaction and NASA-TLX questionaries.

Who Is Running the Clinical Trial?

Phantom Neuro Inc.

Lead Sponsor

Trials

1

Recruited

30+

Atlas Ambulatory Surgery Center

Collaborator

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. trialx.com trialx.com/clinical-trials/listings/314919/wireless-prosthetic-control-effectiveness-study/

Wireless Prosthetic Control Effectiveness Study The study evaluates the ASTERISK system to determine if ASTERISK will increase a user's self-reported satisfaction with their prosthesis as ...

3. 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.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/12/NCT06821412/Prot_SAP_000.pdf

Wireless Prosthetic Control Effectiveness Study As described above, the OPUS-SD (survey) will serve as our primary outcome measure for this study, but we will also collect secondary outcome measures, ...

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

Characteristics of phantom upper limb mobility encourage ... Amputation level, elapsed time since amputation, chronic pain and use of myoelectric prostheses were not found to influence PLM. Five above- ...

6. physio-pedia.com physio-pedia.com/Outcome_Measures_for_Patients_with_Lower_Limb_Amputations

Outcome Measures for Patients with Lower Limb Amputations It is important in the initial stages of rehabilitation to use outcome measures that help predict the ability a patient will have to walk with a prosthesis.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7362458/

Technology for monitoring everyday prosthesis use This paper reviews the scientific literature on methodologies and technologies that have been used to assess the daily use of both upper- and lower-limb ...

8. healthquality.va.gov healthquality.va.gov/guidelines/Rehab/ULA/VADoDULACPG_Final_508.pdf

VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE ... ... below elbow amputations have better functional outcomes in both prosthetic users and replantation compared to persons with above elbow amputations. Although ...

9. 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.