RecruitingNot ApplicableNCT05756894

Neurostimulation for Respiratory Function After Spinal Cord Injury

Pilot Study: Spike-timing-dependent Plasticity for Respiratory Function After Spinal Cord Injury


Sponsor

Shirley Ryan AbilityLab

Enrollment

10 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether non-invasive brain stimulation (transcranial magnetic stimulation, TMS) combined with spinal cord stimulation can improve breathing function in people with high cervical spinal cord injuries (SCI) — injuries at the neck level that often damage the nerve pathways controlling the diaphragm and respiratory muscles. Many of these patients depend on ventilators to breathe, and even a modest improvement in independent breathing would have a profound impact on quality of life. Participants must be adults aged 18–85 with a spinal cord injury at C1–C5, at least 6 months post-injury, and showing significant respiratory deficits (either on a ventilator or with reduced lung capacity below 80% predicted). They must have a trained caregiver available during sessions. People with active depression, history of seizures, metallic skull implants, cardiac pacemakers, pregnancy, or taking drugs that lower seizure threshold are excluded for safety reasons. Participants will receive neurostimulation sessions and have their lung function and breathing independence assessed throughout the study. This research is significant because respiratory failure is the leading cause of death and hospitalisation in high-level SCI, and even partial restoration of breathing could reduce ventilator dependence.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeurostimulation

Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.

OTHERRepiratory training

Respiratory exercises will be completed immediately after completing neurostimulation. Respiratory exercises will involve inspiratory muscle training performing four sets of 6-10 breaths per day with two minutes of rest.


Locations(1)

Shirley Ryan Ability Lab

Chicago, Illinois, United States

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NCT05756894


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