Clinical trial NCT04506099: Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Official title: Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neuropathic Pain
SCI - Spinal Cord Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized sham-controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.

Detailed description: Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our knowledge, neuromodulation has not been performed to prevent the development of chronic neuropathic pain. There has been little published regarding the effects of electric stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and spasticity. Gaps in the knowledge which we intend to fill are:

1. Safety and feasibility of TINS in acute SCI during inpatient rehabilitation.
2. Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission, discharge, and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months.
3. Analysis of neuropathic pain medication dosages in those with and without TINS at admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2- months post-discharge

Eligibility criteria: Inclusion Criteria:

* Acute tSCI paraplegia within 4 weeks of injury (n=22)
* 18-75 years old
* Neurologic levels T1-T10
* English speaking
* Admitted to TIRR with pain medications
* TINS can elicit visible or palpable abdominal muscle contraction

Exclusion Criteria:

* Subjects with pacemakers, defibrillators, insulin pumps, and similar devices
* History of peripheral neuropathy
* History of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in the lower extremities, sharp/jabbing/burning pain in the lower extremities, sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.)
* History of nervous system disorder (i.e. prior SCI, stroke, brain injury, degenerative diseases such as Parkinson's disease, etc.)
* Ventilator dependent respiration
* Inability to speak
* Non-English speakers
* Pregnancy
* History of chronic pain
* Intolerant to electric stimulation
* Intolerant to the trial sessions

Primary outcomes:
measure: Number of participants with morbidity as measured by infections
timeFrame: Admission
measure: Number of participants with morbidity as measured by infections
timeFrame: 4-weeks post injury
measure: Number of participants with morbidity as measured by infections
timeFrame: 2-month follow-up
measure: Number of participants with morbidity as measured by burns.
timeFrame: Admission
measure: Number of participants with morbidity as measured by burns.
timeFrame: 4-weeks post injury
measure: Number of participants with morbidity as measured by burns.
timeFrame: 2-month follow-up
measure: Number of participants with morbidity as measured by urgent transfers.
timeFrame: Admission
measure: Number of participants with morbidity as measured by urgent transfers.
timeFrame: 4-weeks post injury
measure: Number of participants with morbidity as measured by urgent transfers.
timeFrame: 2-month follow up
measure: Number of participants with morbidity as measured by spasticity scores per usual care.
timeFrame: Admission
measure: Number of participants with morbidity as measured by spasticity scores per usual care.
timeFrame: 4-weeks post injury
measure: Number of participants with morbidity as measured by spasticity scores per usual care.
timeFrame: 2-month follow-up
Secondary outcomes:
measure: Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)
timeFrame: Baseline
measure: Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)
timeFrame: 2-month follow-up
measure: Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.
timeFrame: 4-weeks post injury
measure: Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.
timeFrame: 2-month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth
name: Argyrios Stampas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.
citation: McNeill DL, Carlton SM, Hulsebosch CE. Intraspinal sprouting of calcitonin gene-related peptide containing primary afferents after deafferentation in the rat. Exp Neurol. 1991 Dec;114(3):321-9. doi: 10.1016/0014-4886(91)90158-9.
citation: McNeill DL, Hulsebosch CE. Intraspinal sprouting of rat primary afferents after deafferentation. Neurosci Lett. 1987 Oct 16;81(1-2):57-62. doi: 10.1016/0304-3940(87)90340-5.
citation: Diamond J, Foerster A. Recovery of sensory function in skin deprived of its innervation by lesion of the peripheral nerve. Exp Neurol. 1992 Jan;115(1):100-3. doi: 10.1016/0014-4886(92)90229-j. No abstract available.
citation: Gwak YS, Hulsebosch CE. Neuronal hyperexcitability: a substrate for central neuropathic pain after spinal cord injury. Curr Pain Headache Rep. 2011 Jun;15(3):215-22. doi: 10.1007/s11916-011-0186-2.
citation: Stampas A, Korupolu R, Zhu L, Smith CP, Gustafson K. Safety, Feasibility, and Efficacy of Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury Neurogenic Bladder: A Randomized Control Pilot Trial. Neuromodulation. 2019 Aug;22(6):716-722. doi: 10.1111/ner.12855. Epub 2018 Oct 3.
citation: Hatch MN, Cushing TR, Carlson GD, Chang EY. Neuropathic pain and SCI: Identification and treatment strategies in the 21st century. J Neurol Sci. 2018 Jan 15;384:75-83. doi: 10.1016/j.jns.2017.11.018. Epub 2017 Nov 16.
citation: Ataoglu E, Tiftik T, Kara M, Tunc H, Ersoz M, Akkus S. Effects of chronic pain on quality of life and depression in patients with spinal cord injury. Spinal Cord. 2013 Jan;51(1):23-6. doi: 10.1038/sc.2012.51. Epub 2012 May 1.
citation: Johnson MI, Bjordal JM. Transcutaneous electrical nerve stimulation for the management of painful conditions: focus on neuropathic pain. Expert Rev Neurother. 2011 May;11(5):735-53. doi: 10.1586/ern.11.48.
citation: Ko EJ, Chun MH, Kim DY, Yi JH, Kim W, Hong J. The Additive Effects of Core Muscle Strengthening and Trunk NMES on Trunk Balance in Stroke Patients. Ann Rehabil Med. 2016 Feb;40(1):142-51. doi: 10.5535/arm.2016.40.1.142. Epub 2016 Feb 26.
citation: Nichols ME, Meador KJ, Loring DW, Poon LW, Clayton GM, Martin P. Age-related changes in the neurologic examination of healthy sexagenarians, octogenarians, and centenarians. J Geriatr Psychiatry Neurol. 1994 Jan-Mar;7(1):1-7. doi: 10.1177/089198879400700101.
citation: https://www.nscisc.uab.edu/Public/Facts%202015.pdf
citation: Dubeau CE. The aging lower urinary tract. J Urol. 2006 Mar;175(3 Pt 2):S11-5. doi: 10.1016/S0022-5347(05)00311-3.
citation: http://www.emsci.org/index.php/project/the-project/time-schedule
citation: Chartier-Kastler EJ, Denys P, Chancellor MB, Haertig A, Bussel B, Richard F. Urodynamic monitoring during percutaneous sacral nerve neurostimulation in patients with neurogenic detrusor hyperreflexia. Neurourol Urodyn. 2001;20(1):61-71. doi: 10.1002/1520-6777(2001)20:13.0.co;2-d.
citation: Bellucci CH, Wollner J, Gregorini F, Birnbock D, Kozomara M, Mehnert U, Schubert M, Kessler TM. Acute spinal cord injury--do ambulatory patients need urodynamic investigations? J Urol. 2013 Apr;189(4):1369-73. doi: 10.1016/j.juro.2012.10.013. Epub 2012 Oct 12.
citation: Buchele G, Och B, Bolte G, Weiland SK. Single vs. double data entry. Epidemiology. 2005 Jan;16(1):130-1. doi: 10.1097/01.ede.0000147166.24478.f4. No abstract available.
citation: Verrills P, Vivian D, Mitchell B, Barnard A. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med. 2011 Sep;12(9):1395-405. doi: 10.1111/j.1526-4637.2011.01201.x. Epub 2011 Aug 3.
citation: Petersen EA, Slavin KV. Peripheral nerve/field stimulation for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):789-97. doi: 10.1016/j.nec.2014.07.003. Epub 2014 Aug 15.