Combination Therapy to Improve SCI Recovery.

Conditions

• Spinal Cord Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Daily acute intermittent hypoxia — OTHER
  Each participant will be exposed to 8 sessions of daily acute intermittent hypoxia via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).
• Room air (SHAM) — OTHER
  Each participant will be exposed to 8 sessions of daily room air via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02).
• Walking + tSTIM — OTHER
  Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.
• Walking + Sham transcutaneous spinal stimulation (tSHAM) — OTHER
  Individuals will participate in 45 minutes of gait training while having SHAM transcutaneous spinal cord stimulation. The stimulation will briefly increase to 80% involuntary motor threshold and then brought down to 0 within 30 seconds.

Study Details

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.

Key Dates

Start date

Jan 17, 2023

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Change in walking recovery, assessed by 10 meter walk test (10MWT) [ Time Frame: Through study completion, an average of 12 weeks ]

Central Contacts

• Noah Piazza, BS
  617-952-6953
  [email protected]
• Randy Trumbower, PT, PhD
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

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