NCT05756894

Neurostimulation for Respiratory Function After Spinal Cord Injury

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spinal Cord Injuries
• Cervical Spinal Cord Injury
• Respiratory Function Impaired

Interventions

Type	Name	Description
DEVICE	Neurostimulation	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.
OTHER	Repiratory 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.

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-03-07
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study