Neurostimulation for Respiratory Function After Spinal Cord Injury

Last updated: April 1, 2025
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Spinal Cord Injuries

Respiratory Failure

Treatment

Neurostimulation

Repiratory training

Clinical Study ID

NCT05756894
STU00217043
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this research study is to learn more about the connections between the brain, nerves, and diaphragm after experiencing a cervical spinal cord injury (SCI).The main question it aims to answer is:

Changes in respiratory function and recovery using stimulation and respiratory exercise training in spinal cord-injured individuals.

Participants will complete a maximum of 55 study visits. They will be asked to complete about 40 treatment sessions which include multiple stimulation sessions over the scalp and neck, followed by about 60 minutes of respiratory training. Assessment sessions will be completed prior at baseline, after 20 sessions and after 40 sessions of study treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and females between ages 18-85 years

  2. SCI at least 6 months post-injury

  3. Spinal Cord injury at C1-C5

  4. Demonstrate respiratory deficit following spinal cord injury as following: (1)Individuals using mechanical ventilation, and (2) individuals with pulmonaryfunction testing (PFT) deficits corresponding to having a vital capacity (VC) < 80% (predicted)

  5. Must have a family member or caregiver who is trained and willing to operate themechanical ventilator during study visits.

Exclusion

Exclusion Criteria:

  1. Any illness or condition that based on the research team's assessment, willcompromise with the participant's ability to comply with the protocol, patientsafety, or the validity of the data collected during this study.

  2. Any debilitating disease prior to the SCI that caused exercise intolerance.

  3. Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours perday).

  4. Premorbid, ongoing major depression or psychosis, altered cognitive status.

  5. History of head injury or stroke

  6. Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, evenwithout a history of seizure, and without anticonvulsant medication

  7. History of seizures or epilepsy

  8. Receiving drugs acting primarily on the central nervous system, which lower theseizure threshold

  9. Pregnant females

  10. If a woman of childbearing age is unsure of the pregnancy, and does not want to takethe pregnancy test

  11. Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinalcord disease such as spinal stenosis, spina bifida, MS, or herniated disk

  12. Metal plate in skull

  13. Individuals with scalp shrapnel, cochlear implants, or aneurysm clips

  14. Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Intervalprolonging drugs

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Neurostimulation
Phase:
Study Start date:
February 28, 2023
Estimated Completion Date:
December 31, 2026

Study Description

The purpose of this study is to test a strategy to potentiate functional recovery of respiratory function in individuals with spinal cord injury (SCI). Respiratory function is often impaired in individuals with high cervical spinal cord injury (SCI, C1-C5) leading to reduced quality of life and mortality. Currently, research has shown Spike-timing-dependent plasticity (STDP) targeting cortico-motoneuronal connections effectively promote recovery in upper and lower limbs, including functions such as grasping and locomotion. The overall goal of our proposal is to develop a non-invasive protocol using

STDP that can be used to strengthen synaptic plasticity and voluntary motor output in the diaphragm muscle in humans with high cervical SCI. To assess the effect of STDP on respiratory function in humans with high cervical SCI, we propose a pilot study of efficacy trial with the specific aim below:

The overall objective of this project is to investigate the efficacy of spike-timing-dependent plasticity (STDP) on respiratory function in humans with high cervical SCI.

Specific Aim: Examine the effect of STDP in respiratory function in humans with chronic high cervical SCI.

Connect with a study center

  • Shirley Ryan Ability Lab

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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