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Neurostimulation
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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I need a ventilator to breathe or my lung capacity is less than 80% due to a spinal injury.
Select...
My spinal cord injury is between the C1 and C5 vertebrae.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Maximum Voluntary Contractions (MVCs)
Change in Motor evoked potentials (MEPs)
Secondary outcome measures
Change in Cervicomedullary electric potentials (CMEPs)
Change in Pulmonary function tests
Change in the Diaphragm ultrasound imaging
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neurostimulation for respiratory function after spinal cord injuryExperimental Treatment2 Interventions
Efficacy of STDP on respiratory function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurostimulation
2022
N/A
~40
Find a Location
Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
195 Previous Clinical Trials
16,924 Total Patients Enrolled
Monica A Perez, PT, PhDPrincipal InvestigatorShirley Ryan AbilityLab
2 Previous Clinical Trials
284 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or epilepsy.I need a ventilator to breathe or my lung capacity is less than 80% due to a spinal injury.I have a brain condition not caused by seizures and I'm not on seizure medication.I am taking medication that could increase my risk of seizures.You rely completely on a diaphragmatic pacer for breathing support all day, every day.I am currently taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or drugs that prolong the PR Interval.I have had a head injury or stroke in the past.You have a metal plate in your skull.I do not have any health issues that would interfere with the study.I had a condition before my spinal cord injury that made it hard for me to exercise.I have a spinal condition like stenosis, MS, or a herniated disk.I have a history of major depression, psychosis, or cognitive issues.You have metal objects in your head, such as shrapnel, cochlear implants, or aneurysm clips.I am between 18 and 85 years old.You have had a spinal cord injury for at least 6 months.My spinal cord injury is between the C1 and C5 vertebrae.
Research Study Groups:
This trial has the following groups:- Group 1: Neurostimulation for respiratory function after spinal cord injury
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the inclusion criteria for this research broad enough to incorporate individuals over 70 years old?
"Patients aged 18 and above, but under 85 are eligible for enrolment in this clinical trial."
Answered by AI
Could I receive permission to join this experiment?
"To be eligible, applicants must have spinal cord injury and should fall between the ages of 18 to 85. This clinical trial is open for admission to up to 10 individuals."
Answered by AI
How many participants are currently enrolled in this trial?
"Affirmative. According to clinicaltrials.gov, the medical trial was initially posted on February 28th 2023 and is actively seeking enrolment from 10 patients across 1 site."
Answered by AI
Is enrollment open at this moment for the trial?
"As per the clinicaltrials.gov database, this research project is presently in its recruitment phase which began on February 28th of 2023 and was recently updated on the 23rd of that same month."
Answered by AI
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