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Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals

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ClinicalTrials.gov Identifier: NCT03260400
Recruitment Status : Enrolling by invitation
First Posted : August 24, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Cederna, University of Michigan

Brief Summary:
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.

Condition or disease Intervention/treatment Phase
Amputation Neuroma Amputation Device: a bipolar percutaneous intramuscular electromyography electrode Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
Experimental: New Grafts
In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the participant will have a shorter surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After another healing period, experiments with prosthetic control and sensory feedback will begin.
Device: a bipolar percutaneous intramuscular electromyography electrode
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.

Experimental: Existing Grafts
In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The participant will have a short surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After a healing period, experiments with prosthetic control and sensory feedback will begin.
Device: a bipolar percutaneous intramuscular electromyography electrode
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.




Primary Outcome Measures :
  1. Change in Pain Level as measured by SF-36 [ Time Frame: Baseline, 12 months ]
    Change in Pain Level as measured by SF-36 survey Pain will be assessed using the SF-36 survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. Two questions related to pain with a score closer to 0 means a pain increase

  2. Change in Pain Level as measured by LANSS surveys [ Time Frame: Baseline, 12 months ]
    Change in Pain Level as measured by LANSS survey Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. A score greater than 12 indicates neuropathic pain.

  3. RPNI tissue degeneration measured by volume during ultrasound [ Time Frame: Baseline, 12 months ]
    RPNI tissue degeneration will be assessed by ultrasound measurement of the length and diameter of the RPNI. This will be performed before electrode implantation and at a minimum of once per month while electrodes remain implanted. Ultrasound will also be used to assess electrode migration outside of the implanted RPNI graft or muscle.

  4. RPNI electrode migration assessed by ultrasound [ Time Frame: Baseline, 12 months ]
    Ultrasound will be used to assess electrode migration outside of the implanted RPNI graft or muscle.


Secondary Outcome Measures :
  1. EMG signal quality from RPNI grafts [ Time Frame: Baseline, 12 months ]
    Efficacy will be assessed, for each implanted electrode using two calculated signal quality measures: Peak-to-peak signal amplitude during maximum voluntary contraction and signal-to-noise ratio during maximum voluntary contraction.

  2. Stimulation Threshold of RPNI grafts [ Time Frame: Baseline, 12 months ]
    Stimulation data will be recorded at least once per month while electrodes remain implanted. Stimulation threshold will be determined using the range of sensory feedback necessary to evoke a sensory percept.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be 22years of age or older.
  • Participants must have previously undergone an upper limb amputation proximal to the wrist.
  • For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative 305 8procedures. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study. °Participants must be in good health and American Society of Anesthesiologists (ASA) Class I (low surgical risk).
  • Participants must live within 2 hours of the University of Michigan Hospital.
  • Participants must have reliable transportation.
  • Participants must be able to attend at minimum 2 visits per month while electrodes remain implanted.
  • Participants must be at least 12 months post-amputation.

Exclusion Criteria:

  • Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.
  • Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
  • Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.
  • Participants must not have used tobacco for at least one month prior to enrollment in the study.
  • Participants must agree to not use tobacco for the duration of the study.
  • Participants cannot have sustained bilateral upper extremity amputation.
  • Participants cannot be pregnant.
  • Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.
  • Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.
  • Participants must not have an autoimmune condition which is not well controlled by medication.
  • Participants must not be older than 65 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260400


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan

Responsible Party: Paul Cederna, Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering, University of Michigan
ClinicalTrials.gov Identifier: NCT03260400     History of Changes
Other Study ID Numbers: HUM00124839
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Paul Cederna, University of Michigan:
RPNI
Regenerative Peripheral Nerve Interface

Additional relevant MeSH terms:
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms