← Back to Search

Other

Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First for Spinal Cord Injury

N/A
Waitlist Available
Led By Randy Trumbower, PT, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once each intervention week (days 5, 10, and 15), and once at followup (week 8)
Awards & highlights

Study Summary

This trial will test if electrical stimulation of the spinal cord, combined with breathing low-oxygen levels, can improve hand function in people with chronic spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once each intervention week (days 5, 10, and 15), and once at followup (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and once each intervention week (days 5, 10, and 15), and once at followup (week 8) 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 Upper Extremity Function
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
Secondary outcome measures
Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity function
Superiority of combined AIH + TESS Therapy vs. TESS alone to improve upper extremity strength

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) FirstExperimental Treatment3 Interventions
Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM. Round 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH. Washout (1 month) Round 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).
Group II: Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) FirstExperimental Treatment3 Interventions
Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air). Round 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air). Washout (1 month) Round 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins. Round 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM. Round 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
135 Previous Clinical Trials
11,037 Total Patients Enrolled
Randy Trumbower, PT, PhDPrincipal Investigator - Harvard Medical School (HMS and HSDM)
Spaulding Rehabilitation Hospital
2 Previous Clinical Trials
185 Total Patients Enrolled
~1 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top