Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521723
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Low Oxygen Therapy to Enhance Walking Recovery After SCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery for Aging Adults With Chronic SCI The BO2ST-II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BO2ST-II
Brief Summary:
The purpose of this study is to determine how combining bouts of low oxygen transcutaneous spinal cord stimulation and walking training may improve walking function for people with chronic spinal cord injury of different age groups
Detailed Description:
The goal of the study is to determine the optimal dosage for different age groups of repeatedly breathing mild bouts of low oxygen for brief periods termed acute intermittent hypoxia AIH combined with transcutaneous spinal cord stimulation tSTIM to improve recovery of walking and strength after spinal cord injury Preliminary studies have shown that combining AIH and tSTIM with walking training can enhance individuals walking training greater than just AIH or tSTIM By using low oxygen as a pre-treatment to tSTIM during walking training functional independence and quality of life may improve Despite exciting preliminary results supporting the efficacy of AIH and tSTIM to enhance walking recovery after SCI understanding factors that may enhance or undermine treatment responsiveness is warranted Factors include establishing the role of age and sex dependency on appropriate dosing number of sessions AIH to provide the greatest plasticity-promoting effects on walking recovery for our aging population of persons living with SCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None