Ischemic Conditioning for Stroke
Palo Alto (17 mi)Overseen bySangeetha Madhavan, PT, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Illinois at Chicago
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.
What safety data exists for ischemic conditioning in stroke treatment?The provided research does not contain specific safety data for ischemic conditioning or remote ischemic conditioning in stroke treatment. The articles focus on statin therapy and endovascular therapy for ischemic stroke, not ischemic conditioning.123611
Is the treatment Ischemic Conditioning (RIC) a promising treatment for stroke?Yes, Ischemic Conditioning (RIC) is a promising treatment for stroke. It is a safe and noninvasive method that can improve outcomes for stroke patients by potentially reducing brain damage and improving recovery. RIC can be used alongside other treatments to enhance their effectiveness.457812
Do I need to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications that could alter cortical excitability or increase the risk of seizures (like antidepressants, antipsychotics, anxiolytics, or anticonvulsants), you may be excluded from participating.
What data supports the idea that Ischemic Conditioning for Stroke is an effective treatment?The available research shows that Remote Ischemic Conditioning (RIC) may help improve outcomes for stroke patients. One study suggests that when RIC is combined with another treatment called intravenous thrombolysis, it might lead to better recovery in stroke patients. Another study found that RIC has a protective effect on the brain in animal tests, although it's not clear if it helps long-term recovery in humans. Additionally, starting RIC soon after a stroke might be linked to better results. While RIC is simple and cost-effective, more research is needed to fully understand its benefits compared to other treatments.89101314
Eligibility 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
I have difficulty walking due to partial paralysis.
Exclusion Criteria
I have a neurological condition that affects my movement.
I have not had Botox in my legs in the last 6 months.
I have been diagnosed with severe kidney or liver disease.
I have had skull abnormalities or fractures.
I have severe osteoporosis.
I have a history of seizures or epilepsy.
I have high blood pressure that isn't well-controlled.
I have a history of blood vessel or blood disease.
I cannot undergo TMS or IC due to health reasons.
I do not have ongoing infections or unhealed sores that could affect test procedures.
I have a history of blood clots, including in my veins.
I don't have blood clots, open wounds, or nerve damage in my leg.
I have had surgery for blood vessel grafts in my legs.
I am not taking any medication that affects brain activity or increases seizure risk.
I often have headaches for no clear reason.
I have lesions in my brainstem or cerebellum.
I don't have any untreated heart, lung, or high blood pressure conditions.
Treatment Details
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
Loading ...
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
References
HMG CoA reductase inhibitors (statins): use in stroke prevention and outcome after stroke. [2007]The use of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) has been demonstrated to reduce the risk of primary and secondary ischemic stroke in patients with ischemic heart disease (relative risk reduction is 20-30%), confirmed by several prospective randomized placebo-controlled trials. At least one large prospective trial has also shown a similar benefit in patients without underlying ischemic heart disease. This is in contrast to an open-labeled trial conducted in the USA, which failed to demonstrate a significant benefit of statins in reducing stroke risk in hypertensive hyperlipidemic patients. It is less clear if treatment with statins before or after the onset of ischemic stroke also reduces its severity (improves outcome). Experimental animal studies where mice were pretreated with statins, demonstrated a reduced infarct size compared with untreated animals. Treatment with statins after stroke onset has also been demonstrated to enhance recovery without influencing infarct size (by increased angiogenesis, synaptogenesis and blood flow). A few clinical retrospective studies have demonstrated similar results. Prospective blinded placebo-controlled trials to test these findings are still lacking. This review discusses the various prospective trials in stroke prevention and available data on the effects of statins in improving outcome of established ischemic stroke. Alternate mechanisms of statins besides their lipid-lowering effect and relevance in reducing stroke risk and improving outcome are discussed. Finally, based on the present information, an evidence-based perspective about current and future use of statins in the short- and long-term management of ischemic stroke is presented.
Acute endovascular reperfusion therapy in ischemic stroke: a systematic review and meta-analysis of randomized controlled trials. [2018]Randomized controlled trials (RCTs) of endovascular therapy for acute ischemic stroke have had inconsistent results. We evaluated the efficacy and safety of endovascular therapy in published RCTs.
Safety of Statin Pretreatment in Intravenous Thrombolysis for Acute Ischemic Stroke. [2022]A recent meta-analysis investigating the association between statins and early outcomes in acute ischemic stroke (AIS) patients treated with intravenous thrombolysis (IVT) indicated that prestroke statin treatment was associated with increased risk of 90-day mortality and symptomatic intracranial hemorrhage. We investigated the potential association of statin pretreatment with early outcomes in a large, international registry of AIS patients treated with IVT.
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.
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).
The Benefits and Risks of Statin Therapy in Ischemic Stroke: A Review of the Literature. [2020]Statins are effective cholesterol-lowering drugs for reducing the risks of mortality and morbidity of cardiovascular diseases. Increasing evidence has shown that statin use is associated with a significant beneficial effect in patients with ischemic stroke. Both pre-stroke and post-stroke statin use has been found to be beneficial in ischemic stroke. Furthermore, good adherence is associated with a better clinical outcome, and statin withdrawal is associated with a poor functional outcome in patients with ischemic stroke. High-intensity statin therapy is advocated for the treatment of ischemic stroke. However, there are concerns regarding the adverse effects associated with statin use in ischemic stroke such as intracranial hemorrhage. In this review, we summarize the beneficial effect of statin use in ischemic stroke and discuss the potential risks associated with statin therapy.
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.
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).
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.
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.
Key design elements of successful acute ischemic stroke treatment trials. [2023]We review key design elements of positive randomized controlled trials (RCTs) in acute ischemic stroke (AIS) treatment and summarize their main characteristics.
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 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.