Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
NCT ID: NCT04506099
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-07-17
2021-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TINS Active
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. For example, a T7 level of injury will have TINS applied to the T8 level. A T2 level of injury will have TINS applied to the T6 level. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
TINS Active protocol
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Sham protocol
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
Sham protocol
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
Interventions
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TINS Active protocol
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Sham protocol
Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Argyrios Stampas, MD
Spinal Cord Injury Medicine Research Director
Principal Investigators
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Argyrios Stampas, MD
Role: PRINCIPAL_INVESTIGATOR
UTHealth
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
https://www.nscisc.uab.edu/Public/Facts%202015.pdf
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.
http://www.emsci.org/index.php/project/the-project/time-schedule
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.
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.
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.
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.
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.
Other Identifiers
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HSC-MS-20-0048
Identifier Type: -
Identifier Source: org_study_id