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

Spaulding Rehabilitation Hospital, Cambridge, MA

AIH - Intermittent Hypoxia - hypoxia air mixture +2 moreN/AWaitlist AvailableLed by Randy Trumbower, PT, PhDResearch 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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, 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 will 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, once each intervention week (days 5, 10, and 15), and once at followup (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 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 baseline, 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

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

Active Control

Placebo Group

Group I: Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS)Active Control2 Interventions

Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes TESS + Functional Task Practice Duration: 45 minutes

Group II: Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS)Placebo Group2 Interventions

Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes TESS + Functional Task Practice Duration: 45 minutes

0 / 4Eligibility criteria met

Find a site

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

128 Previous Clinical Trials

10,682 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

NeurologyJournal

Effects of Acute Intermittent Hypoxia on Hand Use After Spinal Cord Trauma

Trumbower, Randy D., Heather B. Hayes, Gordon S. Mitchell, Steven L. Wolf, and Victoria A. Stahl. 2017. “Effects of Acute Intermittent Hypoxia on Hand Use After Spinal Cord Trauma”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0000000000004596.

IEEE Transactions on Neural Systems and Rehabilitation EngineeringJournal

Transcutaneous Electrical Spinal Stimulation Promotes Long-term Recovery of Upper Extremity Function in Chronic Tetraplegia

Inanici, Fatma, Soshi Samejima, Parag Gad, V. Reggie Edgerton, Christoph P. Hofstetter, and Chet T. Moritz. 2018. “Transcutaneous Electrical Spinal Stimulation Promotes Long-term Recovery of Upper Extremity Function in Chronic Tetraplegia”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2018.2834339.

Topics in Spinal Cord Injury RehabilitationJournal

Effects of Practice Combined with Somatosensory or Motor Stimulation on Hand Function in Persons with Spinal Cord Injury

Hoffman, Larisa, and Edelle Field-Fote. 2013. “Effects of Practice Combined with Somatosensory or Motor Stimulation on Hand Function in Persons with Spinal Cord Injury”. Topics in Spinal Cord Injury Rehabilitation. American Spinal Injury Association. doi:10.1310/sci1904-288.

Journal of NeurotraumaJournal