Neurostimulation for Spinal Cord Injury

N/A

Recruiting

Led By Monica A Perez, PT, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Spinal Cord injury at C1-C5

Must not have

History of seizures or epilepsy

Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates how spinal cord injury affects the brain, nerves and diaphragm, and how these areas can be improved using stimulation and exercise.

Who is the study for?

This trial is for adults aged 18-85 with a cervical spinal cord injury at C1-C5 level, at least 6 months post-injury. They must have respiratory deficits and either use mechanical ventilation or have vital capacity less than 80% predicted. A family member or caregiver must be able to operate the ventilator during visits. Exclusions include dependence on diaphragmatic pacer, certain medications, brain injuries, seizures, pregnancy, metal in skull, other major illnesses or conditions.

What is being tested?

The study tests how neurostimulation combined with respiratory training affects breathing function after a cervical spinal cord injury. Participants undergo up to 55 visits including about 40 treatment sessions of scalp and neck stimulation followed by an hour of respiratory exercises. Their breathing function is assessed before starting treatments, midway and after completing all sessions.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort from the neurostimulation process such as headaches or skin irritation at the stimulation site; fatigue from the respiratory training; and possible aggravation of existing symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a ventilator to breathe or my lung capacity is less than 80% due to a spinal injury.

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My spinal cord injury is between the C1 and C5 vertebrae.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures or epilepsy.

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I have a brain condition not caused by seizures and I'm not on seizure medication.

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I am taking medication that could increase my risk of seizures.

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I am currently taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or drugs that prolong the PR Interval.

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I had a condition before my spinal cord injury that made it hard for me to exercise.

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I have a spinal condition like stenosis, MS, or a herniated disk.

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I have a history of major depression, psychosis, or cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.