No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for people who have had an acute ischemic stroke and are not eligible for standard treatments. Participants will receive a new type of treatment involving a weak electrical current aimed at improving blood flow to the brain.
Are You a Good Fit for This Trial?
You may be able to join if
I have new neurological symptoms from a stroke.
I am 18 years or older.
I have a blockage in a brain blood vessel.
I can be treated within 24 hours of my last known well time.
I can provide consent to join the study.
I meet specific imaging criteria for salvageable brain tissue.
You may not be able to join if
I have had a brain bleed recently.
I am pregnant.
I have a history of seizure disorder.
I currently have signs of a heart attack.
I have any conditions that prevent me from completing the study.
I have known issues with blood clotting.
I experienced a stroke in the last three months.
I have a serious infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Many patients with acute ischemic stroke are ineligible for currently available standard treatments (clot-busting medication, also known as intravenous thrombolytic or mechanical removal of a clot), and many are non-responders, resulting in a low rate of excellent outcomes, which necessitates the development of novel therapies.
In this study, investigators are testing a new treatment in which a w…
Many patients with acute ischemic stroke are ineligible for currently available standard treatments (clot-busting medication, also known as intravenous thrombolytic or mechanical removal of a clot), and many are non-responders, resulting in a low rate of excellent outcomes, which necessitates the development of novel therapies.
In this study, investigators are testing a new treatment in which a weak electrical current will be applied via scalp electrodes to increase collateral blood flow to the brain and rescue the brain tissue at risk of injury. The primary aim is to find an optimal dose of this therapy that is both adequately safe and effective on imaging markers of brain tissue rescue.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* New focal neurologic deficit consistent with AIS
* National Institute of Health Stroke Scale (NIHSS) ≥4 or NIHSS\< 4 in the presence of disabling deficit (a deficit that, if unchanged, would prevent the
* patient from performing basic activities of daily living such as bathing…
Inclusion Criteria:
* New focal neurologic deficit consistent with AIS
* National Institute of Health Stroke Scale (NIHSS) ≥4 or NIHSS\< 4 in the presence of disabling deficit (a deficit that, if unchanged, would prevent the
* patient from performing basic activities of daily living such as bathing, ambulating, toileting, hygiene, and eating or returning to work)
* Age\>18
* Presence of any cortical vessel occlusion, including Internal Carotid Artery, branches of Middle Cerebral Artery, Anterior Cerebral Artery, Posterior Cerebral Artery, Posterior-Inferior Cerebellar Artery
* Presence of salvageable penumbra with perfusion lesion volume to ischemic core volume ratio of ≥ 1.2 on multimodal imaging
* Patient ineligible for endovascular thrombectomy per American Heart/Stroke Associations Guidelines
* Patient is able to be treated with tDCS within 24 hours of last known well time
* A signed informed consent is obtained from the patient or patient's legally authorized representative
Additional inclusion criteria for non-thrombolytic patients
• Patient ineligible for IV lytics per American Heart/American Stroke Associations National Guidelines
Additional inclusion criteria for thrombolytic receiving patients
* Patient eligible for tPA per Guidelines
* Within 2-hours from intravenous thrombolytic start of administration
Exclusion Criteria:
* Acute intracranial hemorrhage
* Presence of MRI and gadolinium contraindications including cardiac implantable devices, cochlear implant, implanted neurostimulation device, unremovable metallic body piercing, magnetic dental implants, drug infusion pumps, estimated glomerular filtration rate of less than 35 mL/min/1.73 m2, allergy to gadolinium
* Evidence of a large Ischemic core volume more than equal to 100 cc
* Presence of transcranial direct current stimulation contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
* Pregnancy
* Signs or symptoms of acute myocardial infarction on admission
* History of seizure disorder or new seizures with presentation of current stroke
* Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, including attendance at the 3-month follow-up visit
* Concomitant experimental therapy
* Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow
* pattern)
* Preexisting coagulopathy
* Patients suspected of having infective endocarditis and ischemic stroke related to septic emboli
* Patients suspected or known to be infected with coronavirus 2019 (COVID-19)
* Patient with radiographic evidence or suspicion of chronic conditions that may predispose them to intracranial hemorrhage, including brain arteriovenous malformations, cerebral cavernous malformations, cerebral telangiectasia, multiple previous intracerebral hemorrhages (amyloid angiopathy)
* Suspected cerebral vasculitis based on medical history and imaging
* Suspected cysticercosis
* Suspected cranial dural arteriovenous fistula
* Cerebral venous thrombosis
* Head trauma causing loss of consciousness, concussion, confusion, or a headache within the past 30 days
* Patient has suffered a hemorrhagic or ischemic stroke within the last three (3) months
* History of cancer known to cause hemorrhagic metastases, e.g., melanoma, renal cell carcinoma,
* choriocarcinoma, thyroid carcinoma, lung carcinoma, breast carcinoma, and hepatocellular carcinoma
* History of left atrial myxoma
* Evidence of dissection in the intracranial cerebral arteries
* Suspicion of aortic dissection
* Significant mass effect with midline shift
* The patient is in a coma
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