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American Heart Association- Stroke/Hypoxia Study

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Intermittent Hypoxia (AIH)
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age ≥18 years;

A first time, unilateral, ischemic, hemispheric stroke, confirmed by magnetic resonance imaging (MRI);

Chedoke assessment > 3

Ability to open and close affected hand

Able to understand and communicate in English

Be able to consent independently

≥ 6 months post stroke

Must have a hemoglobin level above 10g/dl (to be confirmed using handheld noninvasive lab equipment)

Must have ability to attend research visits with a companion for assistance

WOCBP must be comfortable confirming negative pregnancy prior to hypoxia experimental therapy.

Exclusion criteria:

Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI ≥3

Severe aphasia, preventing subject from understanding the protocol and giving written consent;

History of prior neurological disorder;

Pre-existing hypoxic pulmonary disease,

Severe hypertension (>160/100)

Ischemic cardiac disease.

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypoxia

Arm Description

During each session, study participants will receive a single sequence of AIH, consisting of 15 x 60-seconds periods of hypoxia alternating with 90-seconds of normoxia (21% O2), for a total of 30 minutes, whilst in a seated upright position. AIH will be applied by directing gas flow to a reservoir bag connected via plastic tubing to a non re-breathing facemask/respiratory valve system while the participants are in a seated position. Defined gas mixtures will be delivered by manual adjustment of one-way valves attached to a hypoxia generator.

Outcomes

Primary Outcome Measures

Clinical/neurological status over the duration of the study
All adverse events will be reviewed for safety and study continuation by the medical monitor.

Secondary Outcome Measures

National Institute of Health Stroke Scale (NIHSS)
is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score ranging from 0-42.
Fugl- Meyer Assessment
Each test element will be graded on a 3-point ordinal scale and summed up to provide a maximum upper limb score of 66. Reliability and validity have been demonstrated. The FMA will be administered while the subject is seated.
Modified Ashworth Scale
This scale allows for characterization of increases in muscle tone, from low or normal tone to complete limb rigidity. Specifically, we will evaluate the elbow flexors, bilaterally
Grip strength
A dynamometer measures maximum gross grasp (lb.) averaged over three attempts with each hand. The minimum possible value of zero lb. will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Completed bilaterally, if possible
Pinch Strength
Hydraulic Handheld Dynamometer): A dynamometer measures maximum gross grasp (lb.) averaged over 3 attempts with each hand. The minimum possible value of zero lb. will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer.
Elbow strength
monitoring changes in isometric elbow flexion force using a dynamometer. A total of three trials will be taken on each side, with a rest break between trials. The average of the three trials will be recorded.
D-KEFS Color-Word Interference Test
A neuropsychological measure that seeks to evaluate attention and inhibition. Subjects will be asked to read words or name ink colors as quickly as possible within a given time limit. The test supplies the examiner with three separate scores, including an ability to calculate an interference score. This final score allows for interpretation of cognitive flexibility, creativity and cognitive stress. This measure will be utilized to monitor subjects throughout their participation at specific time-points. Audio recording may be taken to ensure accurate recording of responses
5 minute neurological test
Quick short tests to assess clinical status

Full Information

First Posted
June 19, 2019
Last Updated
May 4, 2022
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT04019522
Brief Title
American Heart Association- Stroke/Hypoxia Study
Official Title
An Exploration of Acute Intermittent Hypoxia as a Tool to Enhance Neural Recovery in Stroke Survivors; a Pilot Safety Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Of the 795,000 people who experience a stroke every year in the US, only a small percentage will achieve full recovery. While current therapies promote strength and endurance, none directly address the unique potential of the brain to reorganize following injury. The goal of this project is to explore the effects of a novel therapy, acute intermittent hypoxia (AIH). During this therapy, individuals receive brief bouts of reduced oxygen levels by inhalation through a face mask. (This is akin to being on top of a tall mountain). In brief exposures, AIH is known to trigger the release of specific proteins that help the brain adapt to oxygen reductions. Published results in people with incomplete spinal cord injury have shown that AIH enhances muscle strength and coordination rather quickly. The research team aims to study the effects of AIH in stroke survivors.
Detailed Description
Stroke is the second leading cause of death and a leading cause of long-term disability worldwide. Despite the spontaneous recovery that occurs following a hemispheric stroke, more than half of stroke patients show substantial residual impairments, imposing a significant human and economic burden. This burden is likely to increase in coming decades, due to a rapidly aging population, and the associated progression of cardiovascular risk factors. Accordingly, new interventions to alleviate impairment in stroke survivors are urgently needed. The development and testing of one such novel intervention, termed Acute Intermittent Hypoxia (AIH), is the primary focus of this AHA Innovative Project Award. The aim is to answer questions related to safety and preliminary efficacy of AIH in stroke survivors. First, the Investigators will establish whether brief reductions in inhaled oxygen concentration can be safely tolerated in stroke survivors. A clinician will closely monitor subjects for any adverse events. The second aim is to establish the effects of AIH on elbow flexion/extension strength, and on hand grip and pinch strength. Subjects will be monitored closely for any adverse events during these experiments. Data will be analyzed to determine if there is an improvement in key outcomes at any dose level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
During each session, study participants will receive a single sequence of AIH, consisting of 15 x 60-seconds periods of hypoxia alternating with 90-seconds of normoxia (21% O2), for a total of 30 minutes, whilst in a seated upright position. AIH will be applied by directing gas flow to a reservoir bag connected via plastic tubing to a non re-breathing facemask/respiratory valve system while the participants are in a seated position. Defined gas mixtures will be delivered by manual adjustment of one-way valves attached to a hypoxia generator.
Intervention Type
Other
Intervention Name(s)
Acute Intermittent Hypoxia (AIH)
Intervention Description
An oxygen monitor will continuously measure and record the fraction of inspired oxygen delivered to the subject. Inspired fraction of oxygen (FiO2) of the gas mixture will be individually adjusted using the valve settings to reach the targeted SpO2. The gas mixtures administered during the four sessions will be 21% O2 (target SpO2 = 95%), 17% O2 (target SpO2 = 92%), 13% O2 (target SpO2 = 87%) and 9% O2 (target SpO2 = 82%).
Primary Outcome Measure Information:
Title
Clinical/neurological status over the duration of the study
Description
All adverse events will be reviewed for safety and study continuation by the medical monitor.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale (NIHSS)
Description
is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score ranging from 0-42.
Time Frame
6 days
Title
Fugl- Meyer Assessment
Description
Each test element will be graded on a 3-point ordinal scale and summed up to provide a maximum upper limb score of 66. Reliability and validity have been demonstrated. The FMA will be administered while the subject is seated.
Time Frame
6 days
Title
Modified Ashworth Scale
Description
This scale allows for characterization of increases in muscle tone, from low or normal tone to complete limb rigidity. Specifically, we will evaluate the elbow flexors, bilaterally
Time Frame
6 days
Title
Grip strength
Description
A dynamometer measures maximum gross grasp (lb.) averaged over three attempts with each hand. The minimum possible value of zero lb. will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Completed bilaterally, if possible
Time Frame
6 days
Title
Pinch Strength
Description
Hydraulic Handheld Dynamometer): A dynamometer measures maximum gross grasp (lb.) averaged over 3 attempts with each hand. The minimum possible value of zero lb. will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer.
Time Frame
6 days
Title
Elbow strength
Description
monitoring changes in isometric elbow flexion force using a dynamometer. A total of three trials will be taken on each side, with a rest break between trials. The average of the three trials will be recorded.
Time Frame
6 days
Title
D-KEFS Color-Word Interference Test
Description
A neuropsychological measure that seeks to evaluate attention and inhibition. Subjects will be asked to read words or name ink colors as quickly as possible within a given time limit. The test supplies the examiner with three separate scores, including an ability to calculate an interference score. This final score allows for interpretation of cognitive flexibility, creativity and cognitive stress. This measure will be utilized to monitor subjects throughout their participation at specific time-points. Audio recording may be taken to ensure accurate recording of responses
Time Frame
6 days
Title
5 minute neurological test
Description
Quick short tests to assess clinical status
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age ≥18 years; A first time, unilateral, ischemic, hemispheric stroke, confirmed by magnetic resonance imaging (MRI); Chedoke assessment > 3 Ability to open and close affected hand Able to understand and communicate in English Be able to consent independently ≥ 6 months post stroke Must have a hemoglobin level above 10g/dl (to be confirmed using handheld noninvasive lab equipment) Must have ability to attend research visits with a companion for assistance WOCBP must be comfortable confirming negative pregnancy prior to hypoxia experimental therapy. Exclusion criteria: Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI ≥3 Severe aphasia, preventing subject from understanding the protocol and giving written consent; History of prior neurological disorder; Pre-existing hypoxic pulmonary disease, Severe hypertension (>160/100) Ischemic cardiac disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zev Rymer, MD/PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

American Heart Association- Stroke/Hypoxia Study

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