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Air Mixture + Electrical Stimulation for Spinal Cord Injury (AIHH+tSCS Trial)

N/A

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Non-progressive or central cord spinal cord injury from C2-T1 inclusive

American Spinal Injury Association (ASIA) Impairment Scale or AIS classification B, C, or D

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

AIHH+tSCS Trial Summary

This trial will see if a combination of special breathing, electric stimulation, and exercise can help improve breathing and arm muscle strength in people with spinal cord injury. #SCI #SpinalCordInjury #ClinicalTrial

Who is the study for?

Adults aged 18-65 with non-progressive spinal cord injuries from C2-T1, classified as AIS B, C, or D. They should have impaired breathing strength and be able to engage in therapy programs. Must be at least a year post-injury, capable of consent, have caregiver support, and willing to be recorded.Check my eligibility

What is being tested?

The trial tests if a mix of low oxygen and high carbon dioxide air (AIHH), along with electrical stimulation and exercise training can improve breathing and hand function in those paralyzed due to spinal injury. It involves health questions, AIHH exposure, stimulation sessions, strength testing, blood draw and saliva sample.See study design

What are the potential side effects?

Potential side effects may include discomfort from the electrical stimulation or reactions like dizziness or shortness of breath from the therapeutic air mixture (AIHH). Blood draws might cause bruising or infection at the site.

AIHH+tSCS Trial Eligibility Criteria

Inclusion Criteria

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

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My spinal cord injury is between my neck and upper back and is not getting worse.

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My spinal injury is classified as moderate to severe but not complete.

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It has been at least a year since my spinal cord injury.

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I am between 18 and 65 years old.

AIHH+tSCS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Airway occlusion pressure (P0.1) in minutes of intervention

Change in Forced vital capacity in minutes of intervention

Change in Maximum respiratory voluntary force production in minutes of intervention

+3 more

Secondary outcome measures

Change in Cardiovascular Response in minutes of intervention

AIHH+tSCS Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: SHAM AIHH + tSCS-paired Strength TrainingExperimental Treatment2 Interventions

Participants will receive exposure to SHAM AIHH followed by transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

Group II: AIHH + SHAM tSCS-paired Strength TrainingExperimental Treatment2 Interventions

Participants will receive exposure to AIHH followed by SHAM transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

Group III: AIHH + tSCS-paired Strength TrainingActive Control2 Interventions

Participants will receive exposure to AIHH followed by transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

Group IV: SHAM AIHH + SHAM tSCS-paired Strength TrainingPlacebo Group2 Interventions

Participants will receive exposure to SHAM AIHH followed by SHAM transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,410 Total Patients Enrolled

Justine Dee, PTStudy ChairThomas Jefferson University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings currently available for participants of this trial?

"This medical trial, which was posted on October 16th 2023 and amended on October 23rd of the same year, is actively seeking participants."

Answered by AI

Do I meet the criteria to join this research project?

"Individuals with spinal cord injury between the ages of majority and 65 are eligible for this trial, which has a target recruitment number of 29 participants."

Answered by AI

Is participation in this trial restricted to those below the age of 25?

"The study's terms of participation demand that patients be between the ages of 18 and 65. There are 158 trials specifically for minors, while 796 studies focus on individuals above retirement age."

Answered by AI

What is the cap for recruitment of participants in this medical trial?

"Affirmative, the clinical trial is still recruiting applicants. The initial posting was on 16th October 2023 and it has been modified as of 23rd October 2023. 29 participants are expected to be enrolled across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury

Jayakrishnan Nair 2023. "Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06101199.

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