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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
at least 1 year post-injury (chronic)
difficulty independently performing hand functions in activities of daily living
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must have had the injury for at least 1 year (a chronic injury).
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You have trouble using your hands to do everyday tasks on your own.
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You have a spinal cord injury between your third and seventh cervical vertebrae.
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Your spinal injury is not getting worse.

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
133 Previous Clinical Trials
11,020 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

Frequently Asked Questions

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

Who meets the criteria for participation in this clinical investigation?

"This medical trial is recruiting 10 participants aged between 18-65 with existing spinal cord injuries. Additionally, they must fulfill the remaining criteria: be medically stable and have obtained their physician's permission to take part in this study, suffer from a SCI at or below C3 and at or above C7 level, experience an unchanging etiology for their injury, present an AIS categorization of either C or D upon initial assessment, have been affected by a chronic condition for over one year before enrolment; as well as demonstrate difficulty when performing manual tasks during everyday life."

Answered by AI

Are there any vacant spots for participation in this research?

"According to contemporary reports on clinicaltrials.gov, this trial is presently enrolling subjects. The initial posting was made on October 1st 2022 and the details were most recently updated on June 24th 2022."

Answered by AI

Does this clinical trial afford the opportunity for octogenarians to participate?

"This trial's parameters stipulate that all applicants must be within the 18 to 65 age bracket. In contrast, there are 74 trials recruiting minors and 401 studies enrolling seniors."

Answered by AI

How many volunteers have joined this clinical trial?

"Yes, according to clinicaltrials.gov this trial is currently seeking out participants. The study was posted on October 1st 2022 and updated last June 24th 2022. Ten individuals are needed for the research which will take place at a single location."

Answered by AI
Recent research and studies
~1 spots leftby Mar 2025