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Motor and Neurophysiological Changes After Ischemic Conditioning in Healthy and Individuals With Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Real Ischemic Conditioning
Sham Ischemic Conditioning
Aerobic Exercise
Sponsored by
University of Illinois at Chicago
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 SexesAccepts Healthy Volunteers

Young Healthy Adults: Inclusion Criteria: 18 - 35 years of age No history of neurological impairment Exclusion Criteria: Pre-existing neurological condition Contraindications to TMS or IC Individuals with Stroke: Inclusion Criteria: Single, monohemispheric stroke > 3 months since onset Residual hemiparetic gait deficits (e.g., abnormal gait pattern) Able to walk on the treadmill or cycle on the recumbent stepper Exclusion Criteria: Lesions affecting the brainstem or cerebellum Severe osteoporosis Other neurological disorders that may interfere with motor function Presence of uncontrolled medical conditions (I.e., uncontrolled hypertension, untreated cardiac/ heart disease, or untreated pulmonary/ lung disease) Diagnosis of severe renal (kidney) or hepatic (liver) disease Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures Failure to pass the Physical Activity Readiness Questionnaire Significant cognitive or communication impairment which could impede the understanding of the purpose of study procedures Contraindications to TMS or IC TMS General Exclusion Criteria: Previous adverse reaction to TMS Skull abnormalities or fractures Concussion within the last 6 months Unexplained, recurring headaches Implanted cardiac pacemaker Metal implants in the head or face History of seizures or epilepsy Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants) Current pregnancy IC General Exclusion Criteria: Deep vein thrombosis Peripheral arterial grafts in the lower extremity Blood clots in the leg, or any condition in which compression of the thigh or short-term blood flow restriction is contraindicated (e.g., open wounds in the leg) Presence of uncontrolled hypertension, peripheral vascular disease, or hematological disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Individuals with Stroke

    Young Healthy Adults

    Arm Description

    Will participate in ischemic conditioning and aerobic exercise.

    Will participate in ischemic conditioning.

    Outcomes

    Primary Outcome Measures

    Change in corticomotor excitability for young healthy adults
    Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the nondominant leg.
    Change in corticomotor excitability for individuals with stroke
    Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the paretic leg.
    Change in intracortical inhibition for young healthy adults
    Intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the nondominant leg.
    Change in intracortical inhibition for individuals with stroke
    Intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the paretic leg.
    Change in transcallosal inhibition for young healthy adults
    Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation.
    Change in transcallosal inhibition for individuals with stroke
    Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation.
    Change in gait speed for individuals with stroke
    For individuals with stroke only, self-selected and fast walking will be measured as the average of 3 trials of the 10-meter walk test (10MWT).
    Change in ankle motor control for individuals with stroke
    For individuals with stroke only, reaction time will be measured using a choice reaction time task involving rapid ankle dorsiflexion and plantarflexion movements in a custom built ankle-tracking device.
    Change in lower limb strength for individuals with stroke
    For individuals with stroke only, participants will perform 3 trials each of maximum ankle dorsiflexion and plantarflexion strength.

    Secondary Outcome Measures

    Numerical Rating Scale (NRS) for Pain
    For young healthy adults and individuals with stroke, subjective measures of pain will be reported during ischemic conditioning using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain).

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    June 15, 2023
    Sponsor
    University of Illinois at Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05906602
    Brief Title
    Motor and Neurophysiological Changes After Ischemic Conditioning in Healthy and Individuals With Stroke
    Official Title
    Motor and Neurophysiological Changes After Ischemic Conditioning in Healthy and Individuals With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to test ischemic conditioning (blood flow restriction) as a cortical priming modality to improve gait function in stroke. Cortical priming, a procedure that augments excitability in the brain prior to or during motor training, is emerging as a promising adjunct strategy to facilitate changes in brain activity and improve motor behavior following a neurological injury such as stroke. The main questions it aims to answer are: At what time point during a single session of ischemic conditioning do neuromodulatory effects in the lower limb motor cortex take place? Can ischemic conditioning be used as a cortical priming modality to improve walking function in stroke when compared to aerobic exercise? Participants will take part in two sessions of ischemic conditioning where a cuff (similar to ones that measure blood pressure) will be placed on the thigh and inflated to one of two blood flow restriction pressures (real or sham). Each participant will experience measures of brain activity before, during, and after both sessions of ischemic conditioning. Individuals with stroke will participate in one additional session of aerobic exercise. Researchers will compare ischemic conditioning and aerobic exercise as cortical priming modalities in stroke to see if they produce similar changes in brain activity and similar performances on subsequent motor behavior tasks.

    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
    Sequential Assignment
    Masking
    Participant
    Masking Description
    Participants will be masked to the type of ischemic conditioning they receive (real or sham). Session order will be randomized.
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individuals with Stroke
    Arm Type
    Experimental
    Arm Description
    Will participate in ischemic conditioning and aerobic exercise.
    Arm Title
    Young Healthy Adults
    Arm Type
    Experimental
    Arm Description
    Will participate in ischemic conditioning.
    Intervention Type
    Device
    Intervention Name(s)
    Real Ischemic Conditioning
    Intervention Description
    While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed on the nondominant or paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Ischemic Conditioning
    Intervention Description
    While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed on the nondominant or paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic Exercise
    Intervention Description
    Pending the results of a screening session to determine the proper exercise modality for participants' physical abilities, participants will perform interval-based aerobic exercise either on a treadmill or recumbent stepper. During aerobic exercise sessions, participants will perform intervals of intense exercise interleaved with rest/ active recovery.
    Primary Outcome Measure Information:
    Title
    Change in corticomotor excitability for young healthy adults
    Description
    Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the nondominant leg.
    Time Frame
    Changes in corticomotor excitability will be calculated within and between sessions at baseline, during IC intervals, immediate-post, and 30-minutes-post both IC sessions (real and sham).
    Title
    Change in corticomotor excitability for individuals with stroke
    Description
    Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the paretic leg.
    Time Frame
    Changes in corticomotor excitability will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post one session of sham IC, real IC, and aerobic exercise.
    Title
    Change in intracortical inhibition for young healthy adults
    Description
    Intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the nondominant leg.
    Time Frame
    Changes in intracortical inhibition will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post both IC sessions (real and sham).
    Title
    Change in intracortical inhibition for individuals with stroke
    Description
    Intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscles of the paretic leg.
    Time Frame
    Changes in intracortical inhibition will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post one session of sham IC, real IC, and aerobic exercise.
    Title
    Change in transcallosal inhibition for young healthy adults
    Description
    Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation.
    Time Frame
    Changes in transcallosal inhibition will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post both IC sessions (real and sham).
    Title
    Change in transcallosal inhibition for individuals with stroke
    Description
    Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation.
    Time Frame
    Changes in transcallosal inhibition will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post one session of sham IC, real IC, and aerobic exercise.
    Title
    Change in gait speed for individuals with stroke
    Description
    For individuals with stroke only, self-selected and fast walking will be measured as the average of 3 trials of the 10-meter walk test (10MWT).
    Time Frame
    Changes in gait speed will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post one session of sham IC, real IC, and aerobic exercise.
    Title
    Change in ankle motor control for individuals with stroke
    Description
    For individuals with stroke only, reaction time will be measured using a choice reaction time task involving rapid ankle dorsiflexion and plantarflexion movements in a custom built ankle-tracking device.
    Time Frame
    Changes in ankle motor control will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post one session of sham IC, real IC, and aerobic exercise.
    Title
    Change in lower limb strength for individuals with stroke
    Description
    For individuals with stroke only, participants will perform 3 trials each of maximum ankle dorsiflexion and plantarflexion strength.
    Time Frame
    Changes in strength will be calculated within and between sessions at baseline, immediate-post, and 30-minutes-post one session of sham IC, real IC, and aerobic exercise.
    Secondary Outcome Measure Information:
    Title
    Numerical Rating Scale (NRS) for Pain
    Description
    For young healthy adults and individuals with stroke, subjective measures of pain will be reported during ischemic conditioning using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain).
    Time Frame
    During each real and sham ischemic conditioning session, pain scores will be reported for each participant during intervals of blow flow restriction and reperfusion through study completion, an average of 1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Young Healthy Adults: Inclusion Criteria: 18 - 35 years of age No history of neurological impairment Exclusion Criteria: Pre-existing neurological condition Contraindications to TMS or IC Individuals with Stroke: Inclusion Criteria: Single, monohemispheric stroke > 3 months since onset Residual hemiparetic gait deficits (e.g., abnormal gait pattern) Able to walk on the treadmill or cycle on the recumbent stepper Exclusion Criteria: Lesions affecting the brainstem or cerebellum Severe osteoporosis Other neurological disorders that may interfere with motor function Presence of uncontrolled medical conditions (I.e., uncontrolled hypertension, untreated cardiac/ heart disease, or untreated pulmonary/ lung disease) Diagnosis of severe renal (kidney) or hepatic (liver) disease Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures Failure to pass the Physical Activity Readiness Questionnaire Significant cognitive or communication impairment which could impede the understanding of the purpose of study procedures Contraindications to TMS or IC TMS General Exclusion Criteria: Previous adverse reaction to TMS Skull abnormalities or fractures Concussion within the last 6 months Unexplained, recurring headaches Implanted cardiac pacemaker Metal implants in the head or face History of seizures or epilepsy Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants) Current pregnancy IC General Exclusion Criteria: Deep vein thrombosis Peripheral arterial grafts in the lower extremity Blood clots in the leg, or any condition in which compression of the thigh or short-term blood flow restriction is contraindicated (e.g., open wounds in the leg) Presence of uncontrolled hypertension, peripheral vascular disease, or hematological disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark Q Cummings, BS
    Phone
    3123550084
    Email
    mcummi8@uic.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sangeetha Madhavan, PT, PhD
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Motor and Neurophysiological Changes After Ischemic Conditioning in Healthy and Individuals With Stroke

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