StrokeNCT05906602

Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

A study testing Real Ischemic Conditioning in people with Stroke, run by University of Illinois at Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Stroke
What is being tested?: Real Ischemic Conditioning
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 20 May 2024to 31 Dec 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 23Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois Chicago
Chicago, Illinois, 60612

Other trials in United States

About this study

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
Being tested: Real Ischemic Conditioning, Sham Ischemic Conditioning
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Real Ischemic ConditioningDevice
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 ConditioningDevice
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.

Study groups in NCT05906602
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Real Ischemic Conditioning; Device: Sham Ischemic Conditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202431 Dec 2025

First posted18 Jun 2023
Study start20 May 2024
Primary completion31 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by University of Illinois at ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05906602
Sponsor's protocol ID: 2022-1620
Status last verified: Apr 2026
First submitted: 17 Feb 2023
Last updated: 19 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Cummings M, Hannigan L, Madhavan S. Ischemic Conditioning Enhances Corticomotor Excitability, Strength, and Motor Control in the Short Term After Chronic Stroke. Neuromodulation. 2026 Jun 12:S1094-7159(26)00152-2. doi: 10.1016/j.neurom.2026.05.010. Online ahead of print.
PubMed 42435025

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke
ClinicalTrials.gov ID: NCT05906602
Acronym / sponsor ID: 2022-1620
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Illinois at ChicagoUniversity, hospital or other
Study start: 20 May 2024 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 18 Jun 2023 (actual)
Results: Posted 23 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Ischemic Conditioning then Sham Ischemic Conditioning	Experimental	Device: Real Ischemic Conditioning, Device: Sham Ischemic ConditioningWhile 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.
Sham Ischemic Conditioning then Ischemic Conditioning	Sham comparator	Device: Real Ischemic Conditioning, Device: Sham Ischemic ConditioningWhile 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Real Ischemic Conditioning10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.	Device	Ischemic Conditioning then Sham Ischemic Conditioning, Sham Ischemic Conditioning then Ischemic Conditioning
Sham Ischemic ConditioningSham 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.	Device	Ischemic Conditioning then Sham Ischemic Conditioning, Sham Ischemic Conditioning then Ischemic Conditioning

Primary outcome

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.
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.
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.
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.

1 secondary outcome

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.

Results and safety

Results posted to the registry on 23 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ischemic Conditioning Then Sham Ischemic Conditioning	11	11
Sham Ischemic Conditioning Then Ischemic Conditioning	9	8

Primary outcome: 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.. Mean (Standard Deviation). Unit: millivolt (mV)

Measure	Ischemic Conditioning n = 19	Sham Ischemic Conditioning n = 19
Post	0.38 (0.24)	0.37 (0.28)
Post-30	0.41 (0.27)	0.37 (0.27)

Population analysed: All participants (n=19) who completed one session of real IC and one session of sham IC were analyzed. Participants (n=1) who withdrew from the study or did not complete the interventions were not included in the analyses.

Primary outcome: 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.. Mean (Standard Deviation). Unit: ms

Measure	Ischemic Conditioning n = 19	Sham Ischemic Conditioning n = 19
Post	133.1 (57.1)	113.3 (64.3)
Post-30	133.9 (62.8)	118.8 (66.2)

Primary outcome: 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.. Mean (Standard Deviation). Unit: ms

Measure	Ischemic Conditioning n = 19	Sham Ischemic Conditioning n = 19
Post	0.55 (0.24)	0.58 (0.22)
Post-30	0.52 (0.21)	0.53 (0.17)

Primary outcome: 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.. Mean (Standard Deviation). Unit: pound-force (lbf)

Measure	Ischemic Conditioning n = 19	Sham Ischemic Conditioning n = 19
Dorsiflexion Post	4.6 (1.3)	4.3 (1.0)
Dorsiflexion Post-30	4.7 (1.4)	4.3 (1.0)
Plantarflexion Post	4.3 (1.9)	3.6 (1.4)
Plantarflexion Post-30	4.0 (1.8)	3.7 (1.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ischemic Conditioning	0 of 19 (0%)	8 of 19 (42.1%)	0 of 19
Sham Ischemic Conditioning	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42435025Cummings M, Hannigan L, Madhavan S. Ischemic Conditioning Enhances Corticomotor Excitability, Strength, and Motor Control in the Short Term After Chronic Stroke. Neuromodulation. 2026 Jun 12:S1094-7159(26)00152-2. doi: 10.1016/j.neurom.2026.05.010. Online ahead of print.
Individual participant dataSharing planned: No

Related trials for Stroke

Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sangeetha Madhavan, PT, PhD principal investigator

University of Illinois at Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Real Ischemic Conditioning in people with Stroke, run by University of Illinois at Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05906602, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.