Back to resultsRepetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repeated exposure to acute Intermittent Hypoxia (rAIH)
Normal Room Air
Upper-limb Training by Research Staff
Lower-limb Training by Research Staff
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Acute Intermittent Hypoxia, Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion criteria for SCI:
- 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.
Inclusion criteria for controls:
- 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)
Exclusion criteria for SCI and for controls:
- 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.
AIH exclusion criteria (in addition to the above listed exclusion criteria)
- 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
Sites / Locations
- Shirley Ryan AbilityLabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
rAIH + training by research staff
sham rAIH + training
Arm Description
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
Outcomes
Primary Outcome Measures
Upper limb functional measurement
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.
Lower limb functional measurement
10-meter walk test will be used to assess walking speed
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).
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03433599
First Posted
February 8, 2018
Last Updated
June 28, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT03433599
Brief Title
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Official Title
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2020 (Actual)
Primary Completion Date
December 28, 2024 (Anticipated)
Study Completion Date
December 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
U.S. Department of Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Acute Intermittent Hypoxia, Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rAIH + training by research staff
Arm Type
Active Comparator
Arm Description
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
Arm Title
sham rAIH + training
Arm Type
Sham Comparator
Arm Description
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
Intervention Type
Other
Intervention Name(s)
Repeated exposure to acute Intermittent Hypoxia (rAIH)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Normal Room Air
Other Intervention Name(s)
Sham repeated exposure to acute Intermittent Hypoxia (rAIH)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Upper-limb Training by Research Staff
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lower-limb Training by Research Staff
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper limb functional measurement
Description
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) will be used to assess sensation, strength, and prehension.
Time Frame
45 minutes to 1 hour
Title
Lower limb functional measurement
Description
10-meter walk test will be used to assess walking speed
Time Frame
5-10 minutes
Title
MEP/CMEP recruitment curves using TMS
Description
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).
Time Frame
30 minutes to 1 hour
Title
EMG and force voluntary output
Description
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)
Time Frame
30 minutes to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for SCI:
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.
Inclusion criteria for controls:
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)
Exclusion criteria for SCI and for controls:
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.
AIH exclusion criteria (in addition to the above listed exclusion criteria)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Perez, PhD
Phone
312-238-2886
Email
mperez04@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Perez, PhD, PT
Phone
312-238-2886
Email
mperez04@sralab.org
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD
12. IPD Sharing Statement
Learn more about this trial
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
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