Skip to main content
OpenTrials
Completed

NCT Number: NCT05906602

Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

The goal of this clinical trial is to test ischemic conditioning (blood flow restriction) as a neuromodulatory technique to improve gait function in stroke. Neuromodulation 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 this trial aims to answer are:

* Can ischemic conditioning produce neuromodulatory changes in the lower limb primary motor cortex? * Can ischemic conditioning be used as a neuromodulatory technique to improve strength and motor control in individuals with stroke when compared to sham ischemic conditioning?

Participants will take part in two sessions of ischemic conditioning where a cuff (similar to ones that measure blood pressure) will be placed around the thigh and inflated to one of two blood flow restriction pressures (real ischemic conditioning (real IC) and sham ischemic conditioning (sham IC)). Each participant will experience measures of brain activity and motor behavior testing before and after both sessions (real IC and sham IC).

Researchers will investigate ischemic conditioning as neuromodulation modality in stroke to see if ischemic conditioning can produce beneficial changes in brain activity and improvements on subsequent motor behavior tasks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single, stroke > 6 months since onset
  • Residual hemiparetic gait deficits (e.g., abnormal gait pattern)

Exclusion criteria

  • Lesions affecting the brainstem or cerebellum
  • Other neurological disorders that may interfere with motor function
  • Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures
  • Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE<21)), which could impede the understanding of the purpose of procedures of the study
  • Botulinum toxin (Botox) treatments to the lower limb within the past 6 months
  • Pregnant women
  • Contraindications to transcranial magnetic stimulation (TMS) or ischemic conditioning (IC) (Listed below)

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:

  • History of thrombosis (i.e., blood clots) including venous thrombosis or deep vein thrombosis (DVT).
  • Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., open wounds in the leg, bruising, nerve damage, etc.)
  • Peripheral arterial grafts in the lower extremity
  • History of uncontrolled hypertension
  • History of peripheral vascular disease or hematological disease

Treatment and study plan

Real Ischemic Conditioning

Device

10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.

Sham Ischemic Conditioning

Device

Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.

Primary outcomes

  1. Change in Corticomotor Excitability

    Time frame: Changes in corticomotor excitability will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.

    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 muscle of the paretic leg. Higher values indicate more corticomotor excitability.

  2. Change in Transcallosal Inhibition

    Time frame: Changes in transcallosal inhibition will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.

    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. Higher values indicate more inhibition from the stimulated hemisphere to the non-stimulated hemisphere.

  3. Change in Ankle Motor Control

    Time frame: Changes in ankle motor control will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.

    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. Lower values reflect faster reaction times. Only dorsiflexion trials were analyzed to isolate TA activation, while both directions were included to minimize anticipatory activity.

  4. Change in Lower Limb Strength

    Time frame: Changes in strength will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.

    Participants will perform 3 trials each of maximum ankle dorsiflexion and plantarflexion strength. Higher values reflect more strength.

Secondary outcomes

  1. Numerical Rating Scale (NRS) for Pain

    Time frame: During each real and sham ischemic conditioning session. Ratings from each session will be averaged for each participant, and the final value will represent the mean pain rating across all participants for each experimental condition.

    Subjective measures of pain will be reported during ischemic conditioning and sham ischemic conditioning using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain). Ratings from each session will be averaged for each participant, and the final value will represent the mean pain rating across all participants for each experimental condition.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.