Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

Study Overview
=================
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: Safety and feasibility of TINS in acute SCI during inpatient rehabilitation. 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. 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

Official Title
-----------------
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

Conditions
-----------------
Neuropathic Pain, SCI - Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: TINS Active protocol
* Device: Sham protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized sham-controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TINS Active<br>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. | Device: TINS Active protocol<br>* 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.<br>|
| Sham Comparator: Sham protocol<br>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. | Device: Sham protocol<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |