Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

NCT05008185 | Recruiting DMC

• 1 other identifier: Pro00049513
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial

Conditions

Neuroma

Keywords

Neuroma; Neuroma Pain; Finger Amputation; Hand Amputation

Outcome Measures

Primary Outcomes (6)

• Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)

  PROMIS Pain Interference (PROMIS-PI) scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities over the past 7 days answering each questions with a response of not at all, a little bit, somewhat, quite a bit, and very much with not at all being the best and very much the worst.

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• Short-form McGill Pain Questionnaire (SF-MPQ-2)

  theShort-form McGill Pain Questionnaire (SF-MPQ-2) measures 24 different qualities of pain and related symptoms using the intensity of pain and related symptoms felt during the past week on 0 to 10 scale, with 0 being no pain and 10 being the worst pain .

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• PROMIS Global Health (GH) v1.2

  The Global Health Questionnaire contains 10 questions (7 general and 3 about the last 7 days). First 7 questions use a scale of excellent, very good, good, fair, and poor, poor being the worst with excellent being the best. The other three questions use different scales such as; never rarely, sometimes, often or always with never being the best and always being the worst; as well as none, mild, moderate, severe, very severe with none being the best and very severe being the worst; finally pain rating numbered 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• Patient Health Questionnaire (PHQ-9),

  The PHQ-9 form is a brief, self-administered questionnaire that assesses depression symptoms over the last 2 weeks consisting of 10 questions. 9 will be answered on a scale of 0-3 with 0 being the best and 3 bing the worst. The last question will use a response of not difficult at all, somewhat difficult, very difficult, and extremely difficult with not difficult at all being the best and extremely difficult being the worst.

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• Generalized Anxiety Disorder measure (GAD-7),

  Generalized Anxiety Disorder measure (GAD-7) is a screening tool and severity measure for generalised anxiety disorder (GAD) over the past 2 weeks consisting of 7 questions answered on a scale of 0-3 with 0 being the best and 3 being the worst.

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• PC-PTSD-5

  The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screening tool with 'Yes/No" answers designed to identify individuals with probable PTSD. Yes" answers represent the worst and "no" represents the best.

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Secondary Outcomes (13)

• PROMIS UpperExtremity (UE)

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• Brief Michigan Hand Outcomes Questionnaire (bMHQ)

  Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

• Grip Strength

  Assessing change from Baseline to 1 month, 3 months and 6 months

• Pinch Strength -Key and Three-point

  Assessing change from Baseline to 1 month, 3 months and 6 months

• Range of Motion

  Assessing change from Baseline to 1 month, 3 months and 6 months

Study Arms (2)

Regenerative Peripheral Nerve Interface

symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient

Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery

Traction Neurectomy

simple excision and traction neurectomy

Procedure: Traction Neurectomy

Interventions

Regenerative Peripheral Nerve Interface (RPNI) surgery PROCEDURE

Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision

Regenerative Peripheral Nerve Interface

Traction Neurectomy PROCEDURE

Surgeons will perform neuroma resection and traction neurectomy,

Traction Neurectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older with a history of digit, multi-digit or partial hand amputation. Patients must have discrete neuroma pain on clinical exam.

You may qualify if:

• years or older
• History of unilateral digit, multiple digit, or partial hand amputation
• Discrete neuroma pain on clinical exam
• Following standard of care (SOC), confirmation through a local block and/or ultrasound imaging will be performed if indicated
• Must be seen by a hand therapist for at least 6-week trial of desensitization therapy

You may not qualify if:

• Patients with previous surgical treatment for symptomatic neuromas of the digits or hand
• Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss
• women pregnant at time of enrollment
• prisoners
• adults who are unable to consent

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• United States Department of Defense: collaborator
• University of Michigan: collaborator

Study Sites (2)

The Curtis National Hand Center at Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

University of Michigan Plastic Surgery

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Related Publications (18)

• Woo SL, Kung TA, Brown DL, Leonard JA, Kelly BM, Cederna PS. Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Plast Reconstr Surg Glob Open. 2016 Dec 27;4(12):e1038. doi: 10.1097/GOX.0000000000001038. eCollection 2016 Dec.

  PMID: 28293490 BACKGROUND

• Urbanchek MG, Kung TA, Frost CM, Martin DC, Larkin LM, Wollstein A, Cederna PS. Development of a Regenerative Peripheral Nerve Interface for Control of a Neuroprosthetic Limb. Biomed Res Int. 2016;2016:5726730. doi: 10.1155/2016/5726730. Epub 2016 May 17.

  PMID: 27294122 BACKGROUND

• Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.

  PMID: 32115057 BACKGROUND

• Kemp SW, Cederna PS, Midha R. Comparative outcome measures in peripheral regeneration studies. Exp Neurol. 2017 Jan;287(Pt 3):348-357. doi: 10.1016/j.expneurol.2016.04.011. Epub 2016 Apr 17.

  PMID: 27094121 BACKGROUND

• Ursu DC, Urbanchek MG, Nedic A, Cederna PS, Gillespie RB. In vivo characterization of regenerative peripheral nerve interface function. J Neural Eng. 2016 Apr;13(2):026012. doi: 10.1088/1741-2560/13/2/026012. Epub 2016 Feb 9.

  PMID: 26859115 BACKGROUND

• Giladi AM, McGlinn EP, Shauver MJ, Voice TP, Chung KC. Measuring outcomes and determining long-term disability after revision amputation for treatment of traumatic finger and thumb amputation injuries. Plast Reconstr Surg. 2014 Nov;134(5):746e-755e. doi: 10.1097/PRS.0000000000000591.

  PMID: 25347649 BACKGROUND

• Langhals NB, Woo SL, Moon JD, Larson JV, Leach MK, Cederna PS, Urbanchek MG. Electrically stimulated signals from a long-term Regenerative Peripheral Nerve Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1989-92. doi: 10.1109/EMBC.2014.6944004.

  PMID: 25570372 BACKGROUND

• Frost CM, Cederna PS, Martin DC, Shim BS, Urbanchek MG. Decellular biological scaffold polymerized with PEDOT for improving peripheral nerve interface charge transfer. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:422-5. doi: 10.1109/EMBC.2014.6943618.

  PMID: 25569986 BACKGROUND

• Woo SL, Urbanchek MG, Cederna PS, Langhals NB. Revisiting nonvascularized partial muscle grafts: a novel use for prosthetic control. Plast Reconstr Surg. 2014 Aug;134(2):344e-346e. doi: 10.1097/PRS.0000000000000317. No abstract available.

  PMID: 25068369 BACKGROUND

• Kung TA, Langhals NB, Martin DC, Johnson PJ, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interface viability and signal transduction with an implanted electrode. Plast Reconstr Surg. 2014 Jun;133(6):1380-1394. doi: 10.1097/PRS.0000000000000168.

  PMID: 24867721 BACKGROUND

• Kung TA, Bueno RA, Alkhalefah GK, Langhals NB, Urbanchek MG, Cederna PS. Innovations in prosthetic interfaces for the upper extremity. Plast Reconstr Surg. 2013 Dec;132(6):1515-1523. doi: 10.1097/PRS.0b013e3182a97e5f.

  PMID: 24281580 BACKGROUND

• Hooper RC, Cederna PS, Brown DL, Haase SC, Waljee JF, Egeland BM, Kelley BP, Kung TA. Regenerative Peripheral Nerve Interfaces for the Management of Symptomatic Hand and Digital Neuromas. Plast Reconstr Surg Glob Open. 2020 Jun 4;8(6):e2792. doi: 10.1097/GOX.0000000000002792. eCollection 2020 Jun.

  PMID: 32766027 BACKGROUND

• Svientek SR, Ursu DC, Cederna PS, Kemp SWP. Fabrication of the Composite Regenerative Peripheral Nerve Interface (C-RPNI) in the Adult Rat. J Vis Exp. 2020 Feb 25;(156):10.3791/60841. doi: 10.3791/60841.

  PMID: 32176203 BACKGROUND

• Vu PP, Vaskov AK, Irwin ZT, Henning PT, Lueders DR, Laidlaw AT, Davis AJ, Nu CS, Gates DH, Gillespie RB, Kemp SWP, Kung TA, Chestek CA, Cederna PS. A regenerative peripheral nerve interface allows real-time control of an artificial hand in upper limb amputees. Sci Transl Med. 2020 Mar 4;12(533):eaay2857. doi: 10.1126/scitranslmed.aay2857.

  PMID: 32132217 BACKGROUND

• Frost CM, Ursu DC, Flattery SM, Nedic A, Hassett CA, Moon JD, Buchanan PJ, Brent Gillespie R, Kung TA, Kemp SWP, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interfaces for real-time, proportional control of a Neuroprosthetic hand. J Neuroeng Rehabil. 2018 Nov 20;15(1):108. doi: 10.1186/s12984-018-0452-1.

  PMID: 30458876 BACKGROUND

• Vu PP, Irwin ZT, Bullard AJ, Ambani SW, Sando IC, Urbanchek MG, Cederna PS, Chestek CA. Closed-Loop Continuous Hand Control via Chronic Recording of Regenerative Peripheral Nerve Interfaces. IEEE Trans Neural Syst Rehabil Eng. 2018 Feb;26(2):515-526. doi: 10.1109/TNSRE.2017.2772961.

  PMID: 29432117 BACKGROUND

• Ursu D, Nedic A, Urbanchek M, Cederna P, Gillespie RB. Adjacent regenerative peripheral nerve interfaces produce phase-antagonist signals during voluntary walking in rats. J Neuroeng Rehabil. 2017 Apr 24;14(1):33. doi: 10.1186/s12984-017-0243-0.

  PMID: 28438166 BACKGROUND

• Hart SE, Kung TA. Novel Approaches to Reduce Symptomatic Neuroma Pain After Limb Amputation. Curr Phys Med Rehabil Rep. 2020 Jun 16;(8):83-91.

  BACKGROUND

MeSH Terms

Conditions

Neuroma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Aviram M Giladi, MS, MD

  Medstar Union Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaac C Fleming

CONTACT

410-554-2486; ike.c.fleming@medstar.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 17, 2021
• Study Start: October 5, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)