Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

NCT05906602 | Completed Results

• 1 other identifier: 2022-1620
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Change in Corticomotor Excitability

  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.

  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.

• Change in Transcallosal Inhibition

  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.

  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.

• Change in Ankle Motor Control

  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.

  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.

• Change in Lower Limb Strength

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

  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.

Secondary Outcomes (1)

• Numerical Rating Scale (NRS) for Pain

  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.

Study Arms (2)

Ischemic Conditioning then Sham Ischemic Conditioning

EXPERIMENTAL

While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the 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. After a washout period of at least 1 week, participants will then experience sham ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the 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.

Device: Real Ischemic Conditioning; Device: Sham Ischemic Conditioning

Sham Ischemic Conditioning then Ischemic Conditioning

SHAM COMPARATOR

While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the 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. After a washout period of at least 1 week, participants will then experience ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the 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.

Device: Real Ischemic Conditioning; Device: Sham Ischemic Conditioning

Interventions

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.

Ischemic Conditioning then Sham Ischemic Conditioning; Sham Ischemic Conditioning then Ischemic Conditioning

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.

Ischemic Conditioning then Sham Ischemic Conditioning; Sham Ischemic Conditioning then Ischemic Conditioning

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: PRS Training Lead
• Organization: University of Illinois Chicago

awards@uic.edu

(312) 996-4995

Study Officials

• Sangeetha Madhavan, PT, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to the type of ischemic conditioning they receive (real or sham). Treatment arms/ session order (ischemic conditioning and sham ischemic conditioning) will be randomized.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Physical Therapy

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: June 18, 2023
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)