Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury (TINS)

October 15, 2021 updated by: Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Admission
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.
4-weeks post injury
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.
2-month follow-up
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.
Admission
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.
4-weeks post injury
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.
2-month follow-up
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
Admission
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
4-weeks post injury
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
2-month follow up
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
Admission
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
4-weeks post injury
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
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)
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.
Baseline
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.
2-month follow-up
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-weeks post injury
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.
2-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Argyrios Stampas, MD, UTHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 17, 2020

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

November 30, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (ACTUAL)

August 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-20-0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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