Recruiting

Neurostimulation

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05756894

Conditions

Spinal Cord Injuries

Cervical Spinal Cord Injury

Respiratory Function Impaired

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neurostimulation

Repiratory training

Study Details

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

Study ID

NCT05756894

Start date

Feb 28, 2023

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neurostimulation for respiratory function after spinal cord injury

Efficacy of STDP on respiratory function.

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.

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.

Primary outcome measure

  • Change in Motor evoked potentials (MEPs) [ Time Frame: 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) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Monica A Perez, PT, PhD

3122382886mperez04@sralab.org

Sri Ramya Vemulakonda, M.B.B.S

3122382993svemulakon@sralab.org

Locations

Shirley Ryan Ability Lab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sri Ramya Vemulakonda, MBBS

312-238-2993svemulakon@sralab.org

Principal Investigator:

Monica Perez, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-04-04.