Cerebral Hypoxia Clinical Trials

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Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 18 to 70 years of age

• medically stable with medical clearance from study physician to participate

• SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level

• non-progressive etiology of spinal injury

• American Spinal Injury Association (ASIA) scores of C-D at initial screen

• ambulatory (able to complete the 10-meter walk test without support from another person)

• chronic injury (define as \> 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery

Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Massachusetts
Spaulding Rehabilitation Hospital
RECRUITING
Cambridge
Contact Information
Primary
Noah Piazza, BS
npiazza2@mgb.org
617-952-6953
Backup
Randy Trumbower, PT, PhD
randy.trumbower@mgh.harvard.edu
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)
Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
Sham_comparator: Sham + WALKtSTIM
Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
Sham_comparator: AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)
Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with sham transcutaneous spinal cord stimulation.
Related Therapeutic Areas
Sponsors
Leads: Spaulding Rehabilitation Hospital
Collaborators: United States Department of Defense, Shirley Ryan AbilityLab

This content was sourced from clinicaltrials.gov