rAIH + training by research staff for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shirley Ryan AbilityLab, Chicago, ILSpinal Cord InjuryRepeated exposure to acute Intermittent Hypoxia (rAIH) - Other
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a treatment of acute intermittent hypoxia, or periods of low oxygen, can help improve function in people with chronic spinal cord injury.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 5-10 minutes

Hour 1
EMG and force voluntary output
MEP/CMEP recruitment curves using TMS
Hour 1
Upper limb functional measurement
5-10 minutes
Lower limb functional measurement

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

rAIH + training by research staff
1 of 2
sham rAIH + training
1 of 2

Active Control

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: rAIH + training by research staff · Has Placebo Group · N/A

sham rAIH + trainingShamComparator Group · 3 Interventions: Normal Room Air, Upper-limb Training by Research Staff, Lower-limb Training by Research Staff · Intervention Types: Other, Other, Other
rAIH + training by research staffActiveComparator Group · 3 Interventions: Repeated exposure to acute Intermittent Hypoxia (rAIH), Upper-limb Training by Research Staff, Lower-limb Training by Research Staff · Intervention Types: Other, Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5-10 minutes

Who is running the clinical trial?

U.S. Department of EducationFED
85 Previous Clinical Trials
54,306 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
174 Previous Clinical Trials
13,656 Total Patients Enrolled
Monica A Perez, PhDPrincipal InvestigatorShirley Ryan AbilityLab
3 Previous Clinical Trials
303 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can make a strong grip with one hand and move your wrist and ankle muscles slightly.
You must be right-handed to participate in this study because researchers are looking at differences in brain organization between right-handed and left-handed individuals.
You need to be between 18 and 85 years old, regardless of gender.
You have been living with a spinal cord injury for at least 6 months.
You have a spinal cord injury at or above the L2 level.
You have a spinal cord injury that has resulted in complete or incomplete paralysis (ASIA A, B, C, or D).

Frequently Asked Questions

Is this research endeavor seeking to include test subjects who are above the age of forty?

"This clinical trial is accepting applicants above the age of majority but below 85 years old." - Anonymous Online Contributor

Unverified Answer

Who fulfills the criteria for participating in this trial?

"The clinical trial is looking for 60 people with spinal cord injuries in the 18-85 age range." - Anonymous Online Contributor

Unverified Answer

Is recruitment of participants still open for this experiment?

"Research posted on clinicaltrials.gov states that this medical trial is currently recruiting participants. With the initial posting date of April 9th 2020 and last edit being June 28th 2022, recruitment is still in process." - Anonymous Online Contributor

Unverified Answer

What is the maximal quantity of participants in this research?

"Affirmative. Clinicaltrials.gov affirms that this medical experiment, first posted on April 9th 2020, is recruiting patients at present. Approximately 60 volunteers need to be enrolled from 1 healthcare centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.