RECRUITING

Neurostimulation for Respiratory Function After Spinal Cord Injury

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Conditions

Spinal Cord InjuriesCervical Spinal Cord InjuryRespiratory Function ImpairedNeural plasticitySpinal cord injuryDiaphragmRespiratory trainingSpike-timing-dependent plasticityNeurostimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-28
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05756894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and females between ages 18-85 years
  2. 2. SCI at least 6 months post-injury
  3. 3. Spinal Cord injury at C1-C5
  4. 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. 5. Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits.
  1. 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. 2. Any debilitating disease prior to the SCI that caused exercise intolerance.
  3. 3. Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day).
  4. 4. Premorbid, ongoing major depression or psychosis, altered cognitive status.
  5. 5. History of head injury or stroke
  6. 6. Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
  7. 7. History of seizures or epilepsy
  8. 8. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold
  9. 9. Pregnant females
  10. 10. If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test
  11. 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. 12. Metal plate in skull
  13. 13. Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
  14. 14. Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs

Contacts and Locations

Study Contact

Monica A Perez, PT, PhD
CONTACT
3122382886
mperez04@sralab.org
Sri Ramya Vemulakonda, M.B.B.S
CONTACT
3122382993
svemulakon@sralab.org

Principal Investigator

Monica A Perez, PT, PhD
PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab

Study Locations (Sites)

Shirley Ryan Ability Lab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

  • Monica A Perez, PT, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan AbilityLab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-02-28
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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