免费获得国外相关药品，最快 1 个工作日回馈药物信息
American Heart Association- Stroke/Hypoxia Study
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Other: Acute Intermittent Hypoxia (AIH) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Exploration of Acute Intermittent Hypoxia as a Tool to Enhance Neural Recovery in Stroke Survivors; a Pilot Safety Study. |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | February 1, 2022 |
| Estimated Study Completion Date : | February 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Hypoxia
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.
|
Other: Acute Intermittent Hypoxia (AIH)
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%).
|
- Clinical/neurological status over the duration of the study [ Time Frame: 6 days ]All adverse events will be reviewed for safety and study continuation by the medical monitor.
- National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]Quick short tests to assess clinical status
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| Contact: Alexander Barry, MS | 3122381435 | abarry@sralab.org | |
| Contact: Milap Sandhu, PhD | msandhu@sralab.org |
| United States, Illinois | |
| Shirley Ryan AbilityLab | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Sneha Solanki, MS 312-238-3647 ssolanki02@sralab.org | |
| Contact: Milap Sandhu, PhD msandhu@sralab.org | |
| Principal Investigator: William Z Rymer, MD/PhD | |
| Principal Investigator: | Zev Rymer, MD/PhD | Principal Investigator |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 19, 2019 | ||||||||
| First Posted Date ICMJE | July 15, 2019 | ||||||||
| Last Update Posted Date | May 4, 2021 | ||||||||
| Actual Study Start Date ICMJE | February 1, 2019 | ||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Clinical/neurological status over the duration of the study [ Time Frame: 6 days ] All adverse events will be reviewed for safety and study continuation by the medical monitor.
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | American Heart Association- Stroke/Hypoxia Study | ||||||||
| Official Title ICMJE | An Exploration of Acute Intermittent Hypoxia as a Tool to Enhance Neural Recovery in Stroke Survivors; a Pilot Safety Study. | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Stroke | ||||||||
| Intervention ICMJE | Other: Acute Intermittent Hypoxia (AIH)
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%).
|
||||||||
| Study Arms ICMJE | Experimental: Hypoxia
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: Other: Acute Intermittent Hypoxia (AIH)
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
12 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | February 1, 2022 | ||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. |
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04019522 | ||||||||
| Other Study ID Numbers ICMJE | STU: 00208610 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Zev Rymer, Shirley Ryan AbilityLab | ||||||||
| Study Sponsor ICMJE | Shirley Ryan AbilityLab | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Shirley Ryan AbilityLab | ||||||||
| Verification Date | April 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
