Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

Neuropathic Pain Clinical Trial

— TINS  

Official title:

Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04506099
• Other study ID #: HSC-MS-20-0048
• Status: Withdrawn
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• SCI - Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (19)

Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. Review. — View Citation

Ataoglu E, Tiftik T, Kara M, Tunç H, Ersöz 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. — View Citation

Bellucci CH, Wöllner J, Gregorini F, Birnböck 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. — View Citation

Büchele G, Och B, Bolte G, Weiland SK. Single vs. double data entry. Epidemiology. 2005 Jan;16(1):130-1. — View 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. — View 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. Review. — View Citation

Dubeau CE. The aging lower urinary tract. J Urol. 2006 Mar;175(3 Pt 2):S11-5. Review. — View 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. Review. — View 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. Review. — View Citation

http://www.emsci.org/index.php/project/the-project/time-schedule

https://www.nscisc.uab.edu/Public/Facts%202015.pdf

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. Review. — View 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. — View 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. — View Citation

McNeill DL, Hulsebosch CE. Intraspinal sprouting of rat primary afferents after deafferentation. Neurosci Lett. 1987 Oct 16;81(1-2):57-62. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with morbidity as measured by infections	Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections	Admission
Primary	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
Primary	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
Primary	Number of participants with morbidity as measured by burns.	Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.	Admission
Primary	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
Primary	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
Primary	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	Admission
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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.	Baseline
Secondary	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
Secondary	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
Secondary	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