Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05756894

Neurostimulation for Respiratory Function After Spinal Cord Injury

Led by Shirley Ryan AbilityLab · Updated on 2025-04-04

10

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Neurostimulation for Respiratory Function After Spinal Cord Injury

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants aged 18 to 85 years
  • Spinal cord injury at levels C1 to C5
  • At least 6 months have passed since the spinal cord injury
  • Respiratory deficit after spinal cord injury shown by use of mechanical ventilation or pulmonary function testing with vital capacity less than 80% predicted
  • Must have a family member or caregiver trained and willing to operate mechanical ventilator during study visits
Not Eligible

You will not qualify if you...

  • Any illness or condition that may affect ability to follow the study, patient safety, or data validity
  • Any serious disease before spinal cord injury causing exercise intolerance
  • Fully dependent on diaphragmatic pacer support 24 hours per day
  • Major depression, psychosis, or altered cognitive status before the injury
  • History of head injury or stroke
  • Brain lesions from vascular, traumatic, tumoral, infectious, or metabolic causes
  • History of seizures or epilepsy
  • Taking medications that lower seizure threshold
  • Pregnant females or women of childbearing age who refuse pregnancy testing
  • Ongoing spinal cord compression, syrinx, or diseases such as spinal stenosis, spina bifida, multiple sclerosis, or herniated disk
  • Metal plate in skull
  • Presence of scalp shrapnel, cochlear implants, or aneurysm clips
  • Taking specific drugs: Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or drugs that prolong PR interval

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shirley Ryan Ability Lab

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

M

Monica A Perez, PT, PhD

CONTACT

S

Sri Ramya Vemulakonda, M.B.B.S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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