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Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03433599
Enrollment
60
Registered
2018-02-14
Start date
2020-04-09
Completion date
2025-12-28
Last updated
2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Acute Intermittent Hypoxia, Transcranial Magnetic Stimulation

Brief summary

Our goal is to enhance repeated exposure to acute intermittent hypoxia (rAIH)/training-induced aftereffects on upper and lower limb function recovery in humans with chronic spinal cord injury (SCI).

Detailed description

The experiments in this study will test the following: Hypothesis 1.1(Experiment 1) that rAIH will enhance corticospinal excitability and upper and lower limb function in humans with incomplete SCI. Hypothesis 1.2 (Experiment 2) that enhancing the aftereffects of rAIH with exercise training will further enhance upper and lower limb motor function in humans with incomplete SCI. Measurements of corticospinal, cortical, and motoneuron excitability will be tested to further understand the mechanisms of this induced-plasticity. Persons with chronic (\>6 months) spinal cord injury between the levels of C2 and T2. SCI subjects must possess either the ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. Additionally, subject must possess the ability to perform a small visible contraction with dorsiflexion and hip flexor muscles. Controls must be right handed due to potential differences in the organization of the brain in right handed and left handed individuals.

Interventions

OTHERRepeated exposure to acute Intermittent Hypoxia (rAIH)

Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).

OTHERNormal Room Air

Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).

OTHERUpper-limb Training by Research Staff

Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, gross grasping, fine grasping, and hand cycle using an arm ergometer. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

OTHERLower-limb Training by Research Staff

Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general leg/foot movement, over-ground walking, treadmill walking, stair climbing training, leg cycling, standing frame, and NuStep. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.

Sponsors

U.S. Department of Education
CollaboratorFED
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

for SCI: 1. Males and females between 18-85 years 2. Chronic SCI (≥ 6 months post injury) 3. SCI at or above L2 4. ASIA A, B, C, or D, complete or incomplete 5. Possess the following: The ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles. Inclusion criteria for controls: 1. Males and females between 18-85 years 2. Right-handed (Only right-handed individuals will be accepted into this group because of the potential differences in the organization of the brain in right handed and left handed individuals)

Exclusion criteria

for SCI and for controls: 1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease 2. Any debilitating disease prior to the SCI that caused exercise intolerance 3. Premorbid, ongoing major depression or psychosis, altered cognitive status 4. History of head injury or stroke 5. Metal plate in skull 6. History of seizures 7. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant 8. Pregnant females 9. Ongoing cord compression or a syrinx in the spinal cord or a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk. AIH

Design outcomes

Primary

MeasureTime frameDescription
Upper limb functional measurement45 minutes to 1 hourThe Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.
Lower limb functional measurement5-10 minutes10-meter walk test will be used to assess walking speed
MEP/CMEP recruitment curves using TMS30 minutes to 1 hourTen Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves).
EMG and force voluntary output30 minutes to 1 hourEMG surface electrodes will be placed over target muscles (deltoid, biceps brachii, first dorsal interosseous, abductor pollicis brevis, quadriceps femoris, tibialis anterior and/or soleus) to measure maximum voluntary contraction (MVC)

Countries

United States

Contacts

Primary ContactMonica Perez, PhD
mperez04@sralab.org312-238-2886

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026