NCT03433599

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 9, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4.7 years

First QC Date

February 8, 2018

Last Update Submit

June 28, 2022

Conditions

Spinal Cord Injuries

Keywords

Acute Intermittent HypoxiaTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (4)

  • Upper limb functional measurement

    The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.

    45 minutes to 1 hour

  • Lower limb functional measurement

    10-meter walk test will be used to assess walking speed

    5-10 minutes

  • MEP/CMEP recruitment curves using TMS

    Ten 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).

    30 minutes to 1 hour

  • EMG and force voluntary output

    EMG 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)

    30 minutes to 1 hour

Study Arms (2)

rAIH + training by research staff

ACTIVE COMPARATOR

Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.

Other: Repeated exposure to acute Intermittent Hypoxia (rAIH)Other: Upper-limb Training by Research StaffOther: Lower-limb Training by Research Staff

sham rAIH + training

SHAM COMPARATOR

Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.

Other: Normal Room AirOther: Upper-limb Training by Research StaffOther: Lower-limb Training by Research Staff

Interventions

Repeated exposure to acute Intermittent Hypoxia (rAIH)OTHER

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).

rAIH + training by research staff
Normal Room AirOTHER

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).

Also known as: Sham repeated exposure to acute Intermittent Hypoxia (rAIH)
sham rAIH + training
Upper-limb Training by Research StaffOTHER

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.

rAIH + training by research staffsham rAIH + training
Lower-limb Training by Research StaffOTHER

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.

rAIH + training by research staffsham rAIH + training

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 18-85 years
  • Chronic SCI (≥ 6 months post injury)
  • SCI at or above L2
  • ASIA A, B, C, or D, complete or incomplete
  • 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.
  • Males and females between 18-85 years
  • 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)

You may not qualify if:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  • Any debilitating disease prior to the SCI that caused exercise intolerance
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of head injury or stroke
  • Metal plate in skull
  • History of seizures
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant
  • Pregnant females
  • Ongoing cord compression or a syrinx in the spinal cord or a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk.
  • Resting heart rate ≥120 BPM
  • Resting systolic blood pressure \>180 mm Hg
  • Resting diastolic Blood Pressure \>100 mmHg
  • Self-reported history of unstable angina or myocardial infarction within the previous month
  • Resting SpO2 ≥ 95%
  • Cardiopulmonary complications such as COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Monica A Perez, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Perez, PhD

CONTACT

312-238-2886mperez04@sralab.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Chair Arms + Hands AbilityLab

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 14, 2018

Study Start

April 9, 2020

Primary Completion

December 28, 2024

Study Completion

December 28, 2025

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

US(1)