Clinical trial NCT05008185: Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation
Official title: Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroma
Keywords: Neuroma
Neuroma Pain
Finger Amputation
Hand Amputation
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Michigan
First posted: 2021-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

Detailed description: This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: Short-form McGill Pain Questionnaire (SF-MPQ-2)
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: PROMIS Global Health (GH) v1.2
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: Patient Health Questionnaire (PHQ-9),
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: Generalized Anxiety Disorder measure (GAD-7),
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: PC-PTSD-5
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
Secondary outcomes:
measure: PROMIS UpperExtremity (UE)
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: Brief Michigan Hand Outcomes Questionnaire (bMHQ)
timeFrame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
measure: Grip Strength
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Pinch Strength -Key and Three-point
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Range of Motion
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Fine Motor Function - 9-Hole Peg Test (9HPT)
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: FunctionalTask Testing - Lifting boxes
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Functional Task Testing - Carrying Boxes
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Functional Task Testing - Push/Pull sled
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Functional Task Testing - Hammer
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Functional Task Testing - Vice Grip
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Functional Task Testing - Gear Shifting
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
measure: Functional Task Testing - Weapon Recoil
timeFrame: Assessing change from Baseline to 1 month, 3 months and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Curtis National Hand Center at Medstar Union Memorial Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Plastic Surgery
state: Michigan
Study officials:
affiliation: Medstar Union Memorial Hospital
name: Aviram M Giladi, MS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.