Neurostimulation for Respiratory Function After Spinal Cord Injury

NCT ID: NCT05756894

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurostimulation for respiratory function after spinal cord injury

Efficacy of STDP on respiratory function.

Group Type: EXPERIMENTAL

Neurostimulation

Intervention Type: DEVICE

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.

Repiratory training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Spike-timing-dependent plasticity (STDP stimulation); Neural plasticity

Eligibility Criteria

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 pulmonary function 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 the mechanical ventilator during study visits.

Exclusion Criteria

1. Any illness or condition that based on the research team's assessment, will compromise with the participant's ability to comply with the protocol, patient safety, 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 per day).

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, even without 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 the seizure threshold

9. Pregnant females

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

11. Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord 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 Interval prolonging drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Monica Perez

Scientific Chair, Arms and Hands Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica A Perez, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan Ability Lab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monica A Perez, PT, PhD

Role: CONTACT

mperez04@sralab.org

3122382886

Sri Ramya Vemulakonda, M.B.B.S

Role: CONTACT

svemulakon@sralab.org

3122382993

Facility Contacts

Sri Ramya Vemulakonda, MBBS

Role: primary

svemulakon@sralab.org

312-238-2993

Other Identifiers

STU00217043

Identifier Type: -

Identifier Source: org_study_id