Evaluation of a Multi-electrode Prosthesis Control System for Real-world Tasks Performance in Individuals With Upper Limb Transradial Amputation

NCT ID: NCT07071584

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-06-30

Brief Summary

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. You'll wear a non-invasive version for one day in the clinic. You'll practice hand movements and then do two simple tasks with both your usual prosthesis and the Phantom X system. At the end, you'll fill out short surveys about your experience.

Detailed Description

The goal of this study is to evaluate the functional performance of the Phantom X prosthesis control system using a non-invasive version of its 32-electrode sensor array. All other components, including the Fusion Port, will be in their final clinical form factor, consistent with those used in future implantable configurations. The study will take place during a single, in-clinic session. Informed consent will be obtained either remotely prior to the visit or at the start of the session. Participants will undergo an initial EMG screening to determine signal suitability. Those with insufficient signal quality will be excluded. Eligible participants will be fitted with a universal socket, prosthesis, and the Phantom X system. Accelerometers will be placed on both limbs for movement tracking. Participants will practice a predefined set of gestures, followed by system calibration. Two validated functional assessments, Assessment of Capacity for Myoelectric Control (ACMC) and Targeted Box and Blocks Test (tBBT), will be conducted under two conditions: with the participant's baseline setup (if applicable) and with Phantom X. The testing order will be randomized. Participants will complete a user satisfaction questionnaire and NASA Task Load Index instrument to measure intuitiveness of Phantom X system before exiting the study.

Conditions

Upper Limb Amputation Below Elbow

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Participants instrumented with cutaneous version of Phantom X system using a universal socket

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.

Group Type: EXPERIMENTAL

Cutaneous Prosthesis Control System

Intervention Type: DEVICE

Prosthesis control system using a multi-electrode cutaneous sensor array

Interventions

Cutaneous Prosthesis Control System

Prosthesis control system using a multi-electrode cutaneous sensor array

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Individuals 21 years in age and older

2. Individuals with unilateral or bilateral amputation at transradial level

3. Patient is willing to comply with study protocol and make required study visits

4. Willingness and ability to sign Informed Consent

Exclusion Criteria

1. Cognitively impaired to follow study instructions

2. Allergies to skin adhesive materials necessary for cutaneous electrode placement

3. Excessive hair growth on arms and inability to shave off the hair for electrode placement

4. Pregnant woman

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

6. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlas Ambulatory Surgery Center

UNKNOWN

Sponsor Role: collaborator

Phantom Neuro Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elad Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Atlas Ambulatory Surgery Center, Buffalo, NY

Locations

Atlas Ambulatory Surgery Center

Buffalo, New York, United States

Site Status: NOT_YET_RECRUITING

Phantom Neuro Inc. Operational Headquarters

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vinod Sharma, PhD

Role: CONTACT

vinod@phantomneuro.com

17633502091

Facility Contacts

Elad Levy, MD

Role: primary

eladlevy@buffalo.edu

1 (716) 218-1000

Vinod Sharma, PhD

Role: primary

vinod@phantomneuro.com

7633502091

Other Identifiers

PN02

Identifier Type: -

Identifier Source: org_study_id