Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2
University of California, Los Angeles
Summary
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.
Description
This multi-site, phase 2a, randomized, sham-controlled, adaptive study aims to identify an optimal dose of a new treatment, cathodal direct current stimulation or C-tDCS, for acute ischemic stroke. This new treatment involves applying a weak inhibitory electrical current to the brain via scalp electrodes in acute stroke patients. The weak electrical current will electrically protect the brain cells not receiving enough oxygen and nutrients due to blood vessel blockage and increase the collateral blood flow to the brain. The study primarily aims to find an optimal dose that shows adequate safe…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sal…
Interventions
- DeviceHigh-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)
The active study treatment involves delivering a weak form of electrical stimulation via 5 small electrodes to the brain tissue at risk of infarction.
- DeviceSham tDCS
Sham patients will have cap and electrodes in place, but no stimulation will be delivered.
Locations (3)
- University of California- Los Angeles (UCLA)Los Angeles, California
- Johns Hopkins Medical CenterBaltimore, Maryland
- Duke Medical Center HospitalDurham, North Carolina