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New treatment option for Acute Ischemic Stroke
Official title Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT06440707
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Acute intracranial hemorrhage
- Presence of MRI and gadolinium contraindications including cardiac implantable devices, cochlear implant, implanted neurostimulation device...
- 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...
- Pregnancy
- Signs or symptoms of acute myocardial infarction on admission
See the full eligibility 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 for non-thrombolytic patients
- Patient ineligible for IV lytics per American Heart/American Stroke Associations National Guidelines Additional for thrombolytic receiving patients
- Patient eligible for tPA per Guidelines
- Within 2-hours from intravenous thrombolytic start of administration
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Baltimore, Maryland, United States
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Baltimore, Maryland, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.