The Effect of Acute Intermittent Hypoxia on Motor Learning

University of Colorado Boulder (CU)

Status: Completed

Conditions: Incomplete Spinal Cord Injury

Treatments: Other: SHAM Acute Intermittent Hypoxia; Other: Acute Intermittent Hypoxia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05341466

P2CHD086844 (U.S. NIH Grant/Contract)

21-3980

Details and patient eligibility

About

The goal of this study is to examine the effect of repetitive acute intermittent hypoxia on motor learning abilities in able-bodied individuals for subsequent study in individuals with incomplete spinal cord injury.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 70 years old (the latter to reduce likelihood of heart disease);
• Medically stable with medical clearance from physician to participate;
• Motor-incomplete spinal cord injuries at or below C2 and at or above L5;
• AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.);
• More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery;
• Ability to advance one step overground with or without assistive devices;

Exclusion criteria

• Severe concurrent illness or pain;
• Recurrent autonomic dysreflexia;
• History of cardiovascular/pulmonary complications;
• Concurrent physical therapy;
• Pregnant at time of enrollment or planning to become pregnant;
• Untreated painful musculoskeletal dysfunction, fracture or pressure sore;
• History of seizures or epilepsy;
• Recurring headaches;
• Concussion within the last six months;
• Depression or manic disorders
• Metal implants in the head, or pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups

Repetitive Acute Intermittent Hypoxia

Experimental group

Description:

5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals

Treatment:

Other: Acute Intermittent Hypoxia

SHAM Acute Intermittent Hypoxia

Sham Comparator group

Description:

5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals

Treatment:

Other: SHAM Acute Intermittent Hypoxia

Control

No Intervention group

Description:

The control group received no AIH exposure.