Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

NCT04506099 | Withdrawn DMC FDA Device

• 1 other identifier: HSC-MS-20-0048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; SCI - Spinal Cord Injury

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)

  Baseline

• Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)

  2-month follow-up

• Number of participants with decreased pain medication dosage compared 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.

  2-month follow-up

Study Arms (2)

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.

Device: TINS Active protocol

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.

Device: Sham protocol

Interventions

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.

TINS Active

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.

Sham protocol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute tSCI paraplegia within 4 weeks of injury (n=22)
• years old
• Neurologic levels T1-T10
• English speaking
• Admitted to TIRR with pain medications
• TINS can elicit visible or palpable abdominal muscle contraction

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (19)

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

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MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Argyrios Stampas, MD

  UTHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Spinal Cord Injury Medicine Research Director

Model Details: Randomized sham-controlled trial

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: August 10, 2020
• Study Start: July 17, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)