Ischemic Conditioning for Stroke
Recruiting in Palo Alto (17 mi)
Overseen bySangeetha Madhavan, PT, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Must not be taking: Antidepressants, Antipsychotics, Anxiolytics, Anticonvulsants
Disqualifiers: Brainstem lesions, Cognitive impairment, Pregnancy, others
Stay on Your Current Meds
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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, motor control, and gait speed 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 or sham). Each participant will experience measures of brain activity and motor behavior testing before and after both sessions (ischemic conditioning and sham ischemic conditioning).
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on medications that could alter brain activity or increase the risk of seizures, like antidepressants or anticonvulsants, you may not be eligible to participate.
What data supports the effectiveness of the treatment Ischemic Conditioning for Stroke?
Research suggests that remote ischemic conditioning (RIC) may help improve outcomes for stroke patients by protecting brain cells and reducing inflammation. Some studies show it could be beneficial when used soon after a stroke, and it might also help with recovery by supporting brain repair.
12345How is the treatment ischemic conditioning unique for stroke?
Ischemic conditioning is unique because it is a noninvasive treatment that involves temporarily restricting blood flow to a limb (like using a blood pressure cuff) to protect the brain during a stroke. Unlike other treatments that directly target the brain, this method works remotely and can be used alongside standard therapies like clot-busting drugs or surgical procedures.
26789Eligibility Criteria
This trial is for individuals aged 18-35 who have had a stroke. It's not open to those with other neurological impairments. Participants will undergo sessions of ischemic conditioning and aerobic exercise to see if these can improve their walking ability after the stroke.Inclusion Criteria
Able to cycle on the recumbent stepper
I had a stroke more than 6 months ago.
I have difficulty walking due to partial paralysis.
Exclusion Criteria
Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q)
I have a neurological condition that affects my movement.
Concussion within the last 6 months
+23 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo two sessions of ischemic conditioning with measures of brain activity and motor behavior testing before and after each session
2 sessions
2 visits (in-person)
Follow-up
Participants are monitored for changes in corticomotor excitability, ankle motor control, transcallosal inhibition, and lower limb strength
1 year
Participant Groups
The study tests whether restricting blood flow using a cuff on the thigh (ischemic conditioning) or doing aerobic exercise can help change brain activity and enhance motor skills like strength, control, and speed in people recovering from a stroke.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ischemic ConditioningExperimental Treatment1 Intervention
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.
Group II: Sham Ischemic ConditioningPlacebo Group1 Intervention
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.
Ischemic Conditioning is already approved in China for the following indications:
🇨🇳 Approved in China as Remote Ischemic Conditioning for:
- Acute ischemic stroke
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
References
A review of remote ischemic conditioning as a potential strategy for neural repair poststroke. [2023]Ischemic stroke is one of the major disabling health-care problem and multiple different approaches are needed to enhance rehabilitation, in which neural repair is the structural basement. Remote ischemic conditioning (RIC) is a strategy to trigger endogenous protect. RIC has been reported to play neuroprotective role in acute stage of stroke, but the effect of RIC on repair process remaining unclear. Several studies have discovered some overlapped mechanisms RIC and neural repair performs. This review provides a hypothesis that RIC is a potential therapeutic strategy on stroke rehabilitation by evaluating the existing evidence and puts forward some remaining questions to clarify and future researches to be performed in the field.
Safety and efficacy of remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke: A multicenter, randomized, parallel-controlled clinical trial (SERIC-IVT) Study design and protocol. [2023]Remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) may improve functional outcomes in patients with acute ischemic stroke (AIS).
Remote Ischemic Conditioning for Motor Recovery after Acute Ischemic Stroke. [2023]Remote ischemic conditioning (RIC) has shown an impressive neuroprotective effect on acute ischemic stroke (AIS) in animal experiments. But whether chronic RIC improves long-term functional outcomes remains unclear.
Time from Onset to Remote Ischemic Conditioning and Clinical Outcome After Acute Moderate Ischemic Stroke. [2023]We conducted a post hoc exploratory analysis of Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS) to determine whether early remote ischemic conditioning (RIC) initiation after stroke onset was associated with clinical outcome in patients with acute moderate ischemic stroke.
Potential Anti-Inflammatory and Anti-Coagulation Effects of One-Time Application of Remote Ischemic Conditioning in Patients With Subacute/Chronic Cerebral Arteriostenosis and Venostenosis. [2023]Remote ischemic conditioning (RIC) is an extremely simple, non-invasive, and cost-effective method with a neuroprotective effect. This study aimed to evaluate the immediate effects of one-time application of RIC on inflammation and coagulation in patients with chronic cerebral vascular stenosis, and compare the different effects of RIC on cerebral arteriostenosis and cerebral venostenosis.
Remote ischemic conditioning for acute stroke patients treated with thrombectomy. [2022]Remote ischemic conditioning (RIC) has been demonstrated to be safe and feasible for patients with acute ischemic stroke (AIS), as well as for those receiving intravenous thrombolysis. We assessed the safety and feasibility of RIC for AIS patients undergoing endovascular treatment (ET).
Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. [2023]Remote ischemic conditioning (RIC) is a remote, transient, and noninvasive procedure providing temporary ischemia and reperfusion. However, there is no comprehensive literature investigating the efficacy and safety of RIC for the treatment of acute ischemic stroke. In the present study, we performed a comprehensive meta-analysis of the available studies.
Remote Ischemic Conditioning in Ischemic Stroke and Myocardial Infarction: Similarities and Differences. [2021]Acute myocardial infarction and ischemic stroke are leading causes of morbidity and mortality worldwide. Although reperfusion therapies have greatly improved the outcomes of patients with these conditions, many patients die or are severely disabled despite complete reperfusion. It is therefore important to identify interventions that can prevent progression to ischemic necrosis and limit ischemia-reperfusion injury. A possible strategy is ischemic conditioning, which consists of inducing ischemia - either in the ischemic organ or in another body site [i.e., remote ischemic conditioning (RIC), e.g., by inflating a cuff around the patient's arm or leg]. The effects of ischemic conditioning have been studied, alone or in combination with revascularization techniques. Based on the timing (before, during, or after ischemia), RIC is classified as pre-, per-/peri-, or post-conditioning, respectively. In this review, we first highlight some pathophysiological and clinical similarities and differences between cardiac and cerebral ischemia. We report evidence that RIC reduces circulating biomarkers of myocardial necrosis, infarct size, and edema, although this effect appears not to translate into a better prognosis. We then review cutting-edge applications of RIC for the treatment of ischemic stroke. We also highlight that, although RIC is a safe procedure that can easily be implemented in hospital and pre-hospital settings, its efficacy in patients with ischemic stroke remains to be proven. We then discuss possible methodological issues of previous studies. We finish by highlighting some perspectives for future research, aimed at increasing the efficacy of ischemic conditioning for improving tissue protection and clinical outcomes, and stratifying myocardial infarction and brain ischemia patients to enhance treatment feasibility.
Remote Limb Ischemic Conditioning during Cerebral Ischemia Reduces Infarct Size through Enhanced Collateral Circulation in Murine Focal Cerebral Ischemia. [2018]Remote ischemic conditioning (RIC) induces protection in focal cerebral ischemia. The conditioning is divided into pre-, per-, and postconditioning. However, the mechanisms of RIC remain unknown.