Upper Extremity AmputeeiSensNCT04430218
Peripheral Interfaces in Amputees for Sensorimotor Integration
A study testing iSens in people with Upper Extremity Amputee, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Upper Extremity Amputee
- What is being tested?
- iSens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2020to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acquired upper limb amputation
- Unilateral or bilateral amputation, above or below elbow
- At least 6 months since time of amputation
- Current user of a myoelectric prosthesis or prescribed to use one
- Viable target nerves in the upper extremity
- Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
Who cannot join
- A contraindication preventing surgery
- Uncontrolled diabetes
- Chronic skin ulcerations
- History of poor wound healing without specific cause
- History of uncontrolled infection without specific cause
- Active infection
Show all 12Show fewer
- Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
- Inability to speak English
- Expectation that MRI will be required at any point for duration of study or while device is implanted.
- Arthritis in the area of implant
- Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
- Presence of auto immune diseases, or conditions requiring immunosuppression.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Melissa S Schmitt, (216) 791-3800 ext. 63801, Melissa.Schmitt@va.gov
Jessica R Jarvela, MS BS, (216) 791-3800 ext. 63801, Jessica.Jarvela@va.gov
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
emily graczyk, PhD, 216-368-5182, elg46@case.edu
Melissa Schmitt, RN, 2167913800 ext. 63801, mss274@case.edu
About this study
The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
Read the detailed description
The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.
- Conditions
- Upper Extremity Amputee
- Being tested
- iSens
- Keywords
- Sensory Feedback, Advanced Control, Sensorimotor feedback, Prostheses and implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSensDevice
The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.
| Study group | Role | What they receive |
|---|---|---|
| iSens | Experimental | 3 months trial with the iSens system Receives: Device: iSens |
| State of the Art Prosthesis | No intervention | 3 months trial with their own prosthesis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience Measure
Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.
Measured: 9 months post implant
Secondary outcomes (1)
Modified Box and Blocks
Measuring the change in numbers of blocks moved during a timed test.
Measured: 9 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start18 Aug 2020
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity AmputeeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs, Case Western Reserve University, University Hospitals Cleveland Medical Center, MetroHealth Medical Center
- Responsible party
- Sponsor
- Investigators
- Emily L Graczyk, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430218
- Sponsor's protocol ID
- A3355-R
- Other IDs
- RX003355-01, HT94252510204, 1612632, CDMRP-PR241366
- Acronym
- iSens
- Status last verified
- Jul 2026
- First submitted
- 12 May 2020
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Deidentified data will be uploaded to a data repository.
Publications
Cady SR, Lambrecht J, Tyler DJ. Enhanced sensory perception and myoelectric control with high channel count implanted sensorimotor systems. J Neural Eng. 2025 Dec 9;22(6):066024. doi: 10.1088/1741-2552/ae24ae.
PubMed 41297066Cady SR, Lambrecht JM, Dsouza KT, Dunning JL, Anderson JR, Malone KJ, Chepla KJ, Graczyk EL, Tyler DJ. First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication. J Neuroeng Rehabil. 2025 Apr 23;22(1):90. doi: 10.1186/s12984-025-01613-z.
PubMed 40269935Lambrecht JM, Cady SR, Peterson EJ, Dunning JL, Dinsmoor DA, Pape F, Graczyk EL, Tyler DJ. A distributed, high-channel-count, implanted bidirectional system for restoration of somatosensation and myoelectric control. J Neural Eng. 2024 Jun 21;21(3). doi: 10.1088/1741-2552/ad56c9.
PubMed 38861967
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Interfaces in Amputees for Sensorimotor Integration
- ClinicalTrials.gov ID
- NCT04430218
- Acronym / sponsor ID
- iSens / A3355-R
- Conditions
- Upper Extremity Amputee
- Keywords
- Sensory Feedback, Advanced Control, Sensorimotor feedback, Prostheses and implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs, Case Western Reserve University, University Hospitals Cleveland Medical Center, MetroHealth Medical Center
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
Detailed description
The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
| Arm | Type | Receives |
|---|---|---|
| iSens | Experimental | Device: iSens3 months trial with the iSens system |
| State of the Art Prosthesis | No intervention | –3 months trial with their own prosthesis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acquired upper limb amputation
- Unilateral or bilateral amputation, above or below elbow
- At least 6 months since time of amputation
- Current user of a myoelectric prosthesis or prescribed to use one
- Viable target nerves in the upper extremity
Key exclusion criteria (12 listed)
- A contraindication preventing surgery
- Uncontrolled diabetes
- Chronic skin ulcerations
- History of poor wound healing without specific cause
- History of uncontrolled infection without specific cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSensThe study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching. | Device | iSens |
Primary outcome
Patient Experience Measure
Time frame: 9 months post implant
Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.
1 secondary outcome
Modified Box and Blocks
Time frame: 9 months post implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 41297066Cady SR, Lambrecht J, Tyler DJ. Enhanced sensory perception and myoelectric control with high channel count implanted sensorimotor systems. J Neural Eng. 2025 Dec 9;22(6):066024. doi: 10.1088/1741-2552/ae24ae.
- Derived from this study: PubMed 40269935Cady SR, Lambrecht JM, Dsouza KT, Dunning JL, Anderson JR, Malone KJ, Chepla KJ, Graczyk EL, Tyler DJ. First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication. J Neuroeng Rehabil. 2025 Apr 23;22(1):90. doi: 10.1186/s12984-025-01613-z.
- Derived from this study: PubMed 38861967Lambrecht JM, Cady SR, Peterson EJ, Dunning JL, Dinsmoor DA, Pape F, Graczyk EL, Tyler DJ. A distributed, high-channel-count, implanted bidirectional system for restoration of somatosensation and myoelectric control. J Neural Eng. 2024 Jun 21;21(3). doi: 10.1088/1741-2552/ad56c9.
- Individual participant dataSharing planned: No. Deidentified data will be uploaded to a data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily L Graczyk, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSens in people with Upper Extremity Amputee, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily L Graczyk, PhD ((216) 791-3800 ext. 63571, Emily.Graczyk@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Experience Measure (time frame: 9 months post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430218, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.