This trial is evaluating whether Non-invasive electromagnetic stimulation for acute stroke treatment will improve 2 primary outcomes and 10 secondary outcomes in patients with Wake-up Stroke. Measurement will happen over the course of 1-7 days post-procedure.
This trial requires 10 total participants across 2 different treatment groups
This trial involves 2 different treatments. Non-invasive Electromagnetic Stimulation For Acute Stroke Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Symptoms occur most commonly between the hours following awakening from sleep and the onset of focal brain ischemia. Symptoms tend to be of moderate intensity and are common with many acute strokes. However, symptoms are often delayed for up to 24 hours and, where the onset is gradual, may be missed by many health services who focus on symptoms of stroke.
At least 80,000 Americans had a nontraumatic wake-up stroke. Wake-up stroke may be more common in females than males. Wake-up stroke has several characteristics that are distinct from stroke in the acute phase of symptom onset.
Most (55%) patients with wake-up stroke will either recover or have symptomatic lesions that will have to be treated during the subsequent decade. The chance of recurrence is higher, if the etiology is uncertain; however, in the majority of these cases, and with careful and early follow-up, the risk of recurrence is low. Patients with nonarteritic ischemic stroke, the most severe type of cerebral infarction (24%), cannot be treated with curative intent or expect to develop long-lasting neurological deficits. Patients with wake-up stroke are very frequently in the public and are very much aware that they may have a higher chance for recurrence and that treatment should focus on maximizing treatment benefits.
Cerebral hypoperfusion is caused by the mechanism of cardioembolism (especially apical left ventricular outflow tract aortic valve obstruction), and atherosclerosis is a possible cause of cerebral hypoperfusion in this patient group. The clinical features of wake-up stroke suggest that this condition may be underdiagnosed and undertreated.
Data from a recent study demonstrates that patients with stroke commonly experience pain, insomnia, and fatigue; these may be managed by addressing these concerns and treatment for these symptoms. Medications may be prescribed to manage these symptoms; treatment with aspirin may reduce the likelihood that patients will awaken from a transient ischemic attack (TIA). No specific intervention for sleep disturbances was reported; this recommendation is based on the observations of this analysis.
Individuals with WUS have high level of risk factors and present earlier than other ischemic stroke subtypes, including lacunar and lacunar+lacunar. The WUS subtype is characterized by early presentation and a worse prognosis. The incidence of WUS is decreasing, and most patients were previously undiscussed.
Stimulation of the sensorimotor cortex can improve quality of life for those with wake-up stroke. Future studies, using a larger number of participants and randomized controlled trials will allow us to determine whether electrostimulation has benefit on stroke recovery.
A majority of studies of NEMS used in acute stroke rehabilitation were published in the last 5 years. The most frequently used NEMS in stroke rehabilitation was weak stimulation. The most commonly combined treatments were different forms of manual therapy, which is not widely studied.
The main side effect from ES is headache, which will subside after 3 days. Other common side effects include muscle pain and insomnia. The headache symptoms are controllable and have only transient effects for the majority of patients and therefore do not have a major impact on treatment efficacy. Muscle pain has a long-term and moderate impact on treatment efficacy. Patients and practitioners should be aware of these side effects when they are planning for the long-term effects of ES. These side effects are transient and will go away within a week. Sleep disturbances are relatively troublesome to deal with, but will disappear too once treatment is stopped.
Although the current knowledge about non-invasive EES is still limited, most of the current findings about this method of treatment are promising. The possible use of this technology in the treatment of stroke patients is yet to be established. More randomized controlled trials are needed. In addition, there is no consensus in the medical literature about most effective treatment settings, intensities and frequencies of stimulation (see discussion). Overall, it appears that EES may be effective in the treatment of acute stroke, but further controlled, randomized trials comparing different stimulation parameters are required.
Non-invasive EEG EEMS has no apparent effect on neurological outcome. Furthermore, we observed no influence of stimulation on hemorrhagic transformation and stroke size compared with conventional treatment.