Neurostimulation for Respiratory Function After Spinal Cord Injury

NCT05756894 | Recruiting DMC FDA Device

• 1 other identifier: STU00217043
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Neural plasticity; Spinal cord injury; Diaphragm; Respiratory training; Spike-timing-dependent plasticity; Neurostimulation

Outcome Measures

Primary Outcomes (2)

• Change in Motor evoked potentials (MEPs)

  Transcranial magnetic stimuli (TMS) will be delivered to the optimal scalp position for activation of the diaphragm muscle. The optimal scalp position will be determined by moving the coil in small steps along the diaphragm representation of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscles.

  MEPs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

• Change in Maximum Voluntary Contractions (MVCs)

  Individuals will perform a maximum voluntary contraction (MVC) of diaphragm muscle through surface electrodes secured to the skin over the chest and belly region.

  MVCs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

Secondary Outcomes (3)

• Change in Cervicomedullary electric potentials (CMEPs)

  CMEPs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

• Change in Pulmonary function tests

  Change in pulmonary function tests measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

• Change in the Diaphragm ultrasound imaging

  Change in the diaphragm ultrasound imaging measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

Study Arms (1)

Neurostimulation for respiratory function after spinal cord injury

EXPERIMENTAL

Efficacy of STDP on respiratory function.

Device: Neurostimulation; Other: Repiratory training

Interventions

Neurostimulation 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.

Also known as: Spike-timing-dependent plasticity (STDP stimulation), Neural plasticity

Neurostimulation for respiratory function after spinal cord injury

Repiratory training 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.

Neurostimulation for respiratory function after spinal cord injury

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females between ages 18-85 years
• SCI at least 6 months post-injury
• Spinal Cord injury at C1-C5
• 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)
• Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits.

You may not qualify if:

• 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.
• Any debilitating disease prior to the SCI that caused exercise intolerance.
• Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day).
• Premorbid, ongoing major depression or psychosis, altered cognitive status.
• History of head injury or stroke
• Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
• History of seizures or epilepsy
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold
• Pregnant females
• If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test
• 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
• Metal plate in skull
• Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
• Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Monica A Perez, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica A Perez, PT, PhD

CONTACT

3122382886; mperez04@sralab.org

Sri Ramya Vemulakonda, M.B.B.S

CONTACT

3122382993; svemulakon@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair, Arms and Hands Lab

Model Details: Participants with high cervical spinal cord injury will receive 40 treatment sessions (STDP stimulation and respiratory training) and will be asked to complete pre-, Post-20, and Post-40 assessment sessions.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: February 28, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)