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Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury (TINS)

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ClinicalTrials.gov Identifier: NCT04506099
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Argyrios Stampas, MD, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain SCI - Spinal Cord Injury Device: TINS Active protocol Device: Sham protocol Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized sham-controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Actual Study Start Date : July 17, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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 Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. Number of participants with morbidity as measured by infections [ Time Frame: Admission ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections

  2. Number of participants with morbidity as measured by infections [ Time Frame: 4-weeks post injury ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.

  3. Number of participants with morbidity as measured by infections [ Time Frame: 2-month follow-up ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.

  4. Number of participants with morbidity as measured by burns. [ Time Frame: Admission ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.

  5. Number of participants with morbidity as measured by burns. [ Time Frame: 4-weeks post injury ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.

  6. Number of participants with morbidity as measured by burns. [ Time Frame: 2-month follow-up ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.

  7. Number of participants with morbidity as measured by urgent transfers. [ Time Frame: Admission ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers

  8. Number of participants with morbidity as measured by urgent transfers. [ Time Frame: 4-weeks post injury ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers

  9. Number of participants with morbidity as measured by urgent transfers. [ Time Frame: 2-month follow up ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers

  10. Number of participants with morbidity as measured by spasticity scores per usual care. [ Time Frame: Admission ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care

  11. Number of participants with morbidity as measured by spasticity scores per usual care. [ Time Frame: 4-weeks post injury ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care

  12. Number of participants with morbidity as measured by spasticity scores per usual care. [ Time Frame: 2-month follow-up ]
    Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care


Secondary Outcome Measures :
  1. Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) [ Time Frame: Baseline ]
    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. Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS) [ Time Frame: 2-month follow-up ]
    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.

  3. Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. [ Time Frame: 4-weeks post injury ]
    Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up.

  4. Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up. [ Time Frame: 2-month follow-up ]
    Compare number of participants with decreased pain medication dosage at discharge and 2-month follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506099


Contacts
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Contact: Argyrios Stampas, MD 713-797-5938 argyrios.stampas@uth.tmc.edu
Contact: Vanessa Bernal, BS 7137977636 vanessa.bernal@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Stampas Argyrios, MD    713-797-5938    argyrios.stampas@uth.tmc.edu   
Contact: Vanessa Bernal    7137977636 ext l    vanessa.bernal@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Argyrios Stampas, MD UTHealth
Publications:
https://www.nscisc.uab.edu/Public/Facts%202015.pdf
http://www.emsci.org/index.php/project/the-project/time-schedule

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Responsible Party: Argyrios Stampas, MD, Spinal Cord Injury Medicine Research Director, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04506099    
Other Study ID Numbers: HSC-MS-20-0048
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations