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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TINS Active | Active Comparator | 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. |
|
| Sham protocol | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TINS Active protocol | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with morbidity as measured by infections | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections | Admission |
| Number of participants with morbidity as measured by infections | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections. | 4-weeks post injury |
| Number of participants with morbidity as measured by infections | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections. | 2-month follow-up |
| Number of participants with morbidity as measured by burns. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. | Admission |
| Number of participants with morbidity as measured by burns. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. | 4-weeks post injury |
| Number of participants with morbidity as measured by burns. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns. | 2-month follow-up |
| Number of participants with morbidity as measured by urgent transfers. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) | Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Argyrios Stampas, MD | UTHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15672627 | Background | 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. | |
| 1748206 | Background | 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. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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Randomized sham-controlled trial
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Study participants will be blinded to the stimulation parameters of the TINS. The research assistant/investigator will apply the electrodes and the PI will be blinded the stimulation setting as well. Unblinding is expected to occur after the 2 month follow up, at which point both subject and PI will be made aware of their group assignment.
|
| Sham protocol | Device | 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. |
|
| Admission |
| Number of participants with morbidity as measured by urgent transfers. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers | 4-weeks post injury |
| Number of participants with morbidity as measured by urgent transfers. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers | 2-month follow up |
| Number of participants with morbidity as measured by spasticity scores per usual care. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care | Admission |
| Number of participants with morbidity as measured by spasticity scores per usual care. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care | 4-weeks post injury |
| Number of participants with morbidity as measured by spasticity scores per usual care. | Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care | 2-month follow-up |
| Baseline |
| Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) | Contains clinically relevant core questions concerning SCI-related pain. This is a 2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity. Developed to augment clinical ratings of spasticity and provide a more comprehensive understanding of an individual's spasticity status. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". The second component is not answered if the person indicates they have no spasms in part. Lower scores indicate better outcomes. | 2-month follow-up |
| Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. | Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up. | 4-weeks post injury |
| Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. | Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up. | 2-month follow-up |
| 3696474 | Background | 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. |
| 1728554 | Background | 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. |
| 21387163 | Background | 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. |
| 30284350 | Background | 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. |
| 29249383 | Background | 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. |
| 22547044 | Background | 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. |
| 21539490 | Background | 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. |
| 26949681 | Background | 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. |
| 8192823 | Background | 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. |
| Background | https://www.nscisc.uab.edu/Public/Facts%202015.pdf |
| 16458733 | Background | 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. |
| Background | http://www.emsci.org/index.php/project/the-project/time-schedule |
| 11135383 | Background | 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. |
| 23069382 | Background | 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. |
| 15613958 | Background | 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. |
| 21812906 | Background | 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. |
| 25240665 | Background | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |