Acute Ischemic StrokePhase 2TESSERACT 2NCT06440707
Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke
A Phase 2 study testing High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS) in people with Acute Ischemic Stroke, run by University of California, Los Angeles at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2025to 1 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
Argye E Hillis, MD, (443) 287-4610, argye@jhmi.edu
Melissa Stockbridge, PhD, md.stockbridge@jhmi.edu
- Recruiting
Duke Medical Center Hospital
Durham, North Carolina, 27710
Wayne Feng, MD, 919-660-4195, wayne.feng@duke.edu
Salman Ikramuddin, MD, 919-255-0870, salman.ikramuddin@duke.edu
- Recruiting
University of California- Los Angeles (UCLA)
Los Angeles, California, 90095
Mersedeh Bahr Hosseini, MD, 310-794-6379, mbahrhosseini@mednet.ucla.edu
Jeffrey L Saver, MD, 310-794-6379, jsaver@mednet.ucla.edu
About this study
Official title: Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2
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.
Read the detailed 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 safety and effectiveness on markers of brain protection and collateral blood flow enhancement using brain scan. The investigators will ask acute stroke patients who arrive at the Emergency Departments of the University of California Los Angeles (UCLA), Duke, and Johns Hopkins Medical Center and are not candidates for clot removal procedure (endovascular thrombectomy) to participate in the study. The study enrolls patients in 2 subgroups depending on their eligibility for clot-busting medication, also known as thrombolytics (thrombolytic receiving and thrombolytic ineligible groups). Then, patients will be randomized in a 5 to 1 ratio to receive active stimulation versus sham (control with no stimulation).
Amongst patients randomized to the active arm, different doses of electrical current will be tested in various ranks, increasing the strength and the total duration of the electrical current at higher ranks. Computer simulation techniques (Bayesian method) will decide which dose patients should be assigned. The deciding rules of whether to escalate versus de-escalate versus stay on the same dose rank will be the probabilities of brain bleeding of ≤40% and substantial rescue of brain tissue at risk of permanent injury of ≥70%. The functional features and rules of the mathematical technique (Bayesian) will justify enrolling up to 50 patients in each subgroup of lytic-receiving and non-lytic-receiving patients (a total of up to 100 patients in active groups). Additionally, 10 sham (control) patients will be enrolled in each subgroup (a total of up to 20 patients in sham groups).
At 24-30 hours after the study stimulation, patients will receive a brain MRI to assess the presence of any brain bleed and how much brain tissue is rescued (primary aims), as well as to examine the additional effects of the study stimulation on brain collateral blood flow and the growth of the permanently damaged brain tissue.
As part of the study's additional goals, the treatment's tolerability will be studied by asking patients about how they feel during and after each session. Patients will also be neurologically examined after each session. Four days after enrollment, a brief neurological assessment will be performed if the patient is still in the hospital. On day 30, patients will receive a call from research personnel to see how they are doing. On day 90, they will be asked to come to neurology clinic to be neurologically assessed. The information gathered from this study will be used to advance this new treatment to future larger studies.
- Conditions
- Acute Ischemic Stroke
- Being tested
- High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS), Sham tDCS
- Keywords
- Cytoprotection, Collateral enhancement
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)Device
The active study treatment involves delivering a weak form of electrical stimulation via 5 small electrodes to the brain tissue at risk of infarction.
Sham tDCSDevice
Sham patients will have cap and electrodes in place, but no stimulation will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation in patients ineligible for intravenous thrombolytic | Active comparator | Patients in the active stimulation group receive cathodal transcranial electrical stimulation via 5 small electrodes for 20 to 60 minutes (min) at 1 or 2 milliamperes (mA) intensities. The duration and intensity of the stimulation will determined by the dose Tier the patient is assigned to. There will be 5 dose tiers, reflecting increasing intensity and duration of stimulation: Tier1- 2 mA, single 20 min cycle; Tier 2 - 1 mA, 2 cycles of 20 min/20 min off; Tier 3- 2mA, 2 cycles of 20 min/20 min off; Tier 4 - 1 mA, 3 cycles of 20min/20 min off; Tier 5 - 2 mA, 3 cycles of 20 min/20 min off.
The decision to which dose Tier the patient should be assigned will be determined by the mathematical Bayesian model. Receives: Device: High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS) |
| Sham stimulation in patients ineligible for intravenous thrombolytic | Sham comparator | Patients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation. Receives: Device: Sham tDCS |
| Transcranial Direct Current Stimulation in patients receiving intravenous thrombolytic | Active comparator | Patients in the active stimulation group receive cathodal transcranial electrical stimulation via 5 small electrodes for 20 to 60 minutes (min) at 1 or 2 milliamperes (mA) intensities. The duration and intensity of the stimulation will determined by the dose Tier the patient is assigned to. There will be 5 dose tiers, reflecting increasing intensity and duration of stimulation: Tier1- 2 mA, single 20 min cycle; Tier 2 - 1 mA, 2 cycles of 20 min/20 min off; Tier 3- 2mA, 2 cycles of 20 min/20 min off; Tier 4 - 1 mA, 3 cycles of 20min/20 min off; Tier 5 - 2 mA, 3 cycles of 20 min/20 min off.
The decision to which dose Tier the patient should be assigned will be determined by the mathematical Bayesian model. Receives: Device: High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS) |
| Sham stimulation in patients receiving intravenous thrombolytic | Sham comparator | Patients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Radiographic Intracranial Hemorrhage
Presence of any intracranial hemorrhage on brain MRI, including hemorrhagic infarction types 1,2 and parenchymal hematoma types 1 and 2.
Measured: At 24-30 hour post-stimulation
Presence of Substantial Penumbra Salvage
Presence of substantial penumbra salvage on hemodynamic brain MRI is defined as the presence of salvage of more than equal to 40% of penumbra.
Measured: At 24-30 hour post-stimulation
Secondary outcomes (8)
Frequency of Symptomatic Intracranial Hemorrhage-Safety Outcome
Number of patients with parenchymal hemorrhage type 2 associated with worsening ≥ 4 on the National Institute of Health Stroke Scale (NIHSS)).
The National Institute of Health Stroke Scale is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment; a higher score indicates worse neurological deficits.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (highest disability), with the minimum score being a 0 (lowest disability).
Measured: At 24-30 hour post-stimulation
Frequency of Early Neurologic Deterioration-Safety Outcome
Number of patients with worsening of more than equal to 4 on the National Institute of Health Stroke Scale (NIHSS) during the 24-hour period after stimulation, with or without intracranial hemorrhage.
The National Institute of Health Stroke Scale is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment; a higher score indicates worse neurological deficits.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (highest disability), with the minimum score being a 0 (lowest disability).
Measured: At 24-hour post-stimulation
All-cause Mortality -Safety Outcome
Number of patients with with outcome of death or modified Rankin Scale of 6
Measured: At day 90 post-stimulation
Frequency of Completion of Stimulation Protocol-Tolerability Outcome
Number of participants who complete the protocol-assigned stimulation treatment without adverse effects as assessed by a modified Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.
Measured: At the end of each 20 minute stimulation period
Frequency and Severity of Adverse Events-Tolerability Outcome
Number of patients who experience adverse events as assessed by a modified Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and severity of each event
Measured: At the end of each 20 minute stimulation period
Amount of Collateral Enhancement- Imaging Efficacy Biomarker Outcome
Percent change in the quantitative relative cerebral blood volume of the ischemic region as an index of collateral enhancement from baseline to post-stimulation
Measured: At 24-30 hour post-stimulation
Infarct Core Growth- Imaging Efficacy Biomarker Outcome
Change in the infarct core volume in milliliters from baseline to post-stimulation
Measured: At 24-30 hour post-stimulation
Reduction in Ischemic Lesion- Imaging Efficacy Biomarker Outcome
Change in perfusion lesion (ischemic lesion with Tmax>6sec) volume from baseline to post-stimulation
Measured: At 24-30 hour post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Jul 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive Bayesian Design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Duke University, Cedars-Sinai Medical Center, University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Mersedeh Bahr Hosseini, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440707
- Sponsor's protocol ID
- 24-000780
- Other IDs
- 1UG3NS134619-01A1
- Acronym
- TESSERACT 2
- Status last verified
- Apr 2026
- First submitted
- 23 May 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2
- ClinicalTrials.gov ID
- NCT06440707
- Acronym / sponsor ID
- TESSERACT 2 / 24-000780
- Conditions
- Acute Ischemic Stroke
- Keywords
- Cytoprotection, Collateral enhancement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Duke University, Cedars-Sinai Medical Center, University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 safety and effectiveness on markers of brain protection and collateral blood flow enhancement using brain scan. The investigators will ask acute stroke patients who arrive at the Emergency Departments of the University of California Los Angeles (UCLA), Duke, and Johns Hopkins Medical Center and are not candidates for clot removal procedure (endovascular thrombectomy) to participate in the study. The study enrolls patients in 2 subgroups depending on their eligibility for clot-busting medication, also known as thrombolytics (thrombolytic receiving and thrombolytic ineligible groups). Then, patients will be randomized in a 5 to 1 ratio to receive active stimulation versus sham (control with no stimulation).
Amongst patients randomized to the active arm, different doses of electrical current will be tested in various ranks, increasing the strength and the total duration of the electrical current at higher ranks. Computer simulation techniques (Bayesian method) will decide which dose patients should be assigned. The deciding rules of whether to escalate versus de-escalate versus stay on the same dose rank will be the probabilities of brain bleeding of ≤40% and substantial rescue of brain tissue at risk of permanent injury of ≥70%. The functional features and rules of the mathematical technique (Bayesian) will justify enrolling up to 50 patients in each subgroup of lytic-receiving and non-lytic-receiving patients (a total of up to 100 patients in active groups). Additionally, 10 sham (control) patients will be enrolled in each subgroup (a total of up to 20 patients in sham groups).
At 24-30 hours after the study stimulation, patients will receive a brain MRI to assess the presence of any brain bleed and how much brain tissue is rescued (primary aims), as well as to examine the additional effects of the study stimulation on brain collateral blood flow and the growth of the permanently damaged brain tissue.
As part of the study's additional goals, the treatment's tolerability will be studied by asking patients about how they feel during and after each session. Patients will also be neurologically examined after each session. Four days after enrollment, a brief neurological assessment will be performed if the patient is still in the hospital. On day 30, patients will receive a call from research personnel to see how they are doing. On day 90, they will be asked to come to neurology clinic to be neurologically assessed. The information gathered from this study will be used to advance this new treatment to future larger studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Adaptive Bayesian Design
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation in patients ineligible for intravenous thrombolytic | Active comparator | Device: High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)Patients in the active stimulation group receive cathodal transcranial electrical stimulation via 5 small electrodes for 20 to 60 minutes (min) at 1 or 2 milliamperes (mA) intensities. The duration and intensity of the stimulation will determined by the dose Tier the patient is assigned to. There will be 5 dose tiers, reflecting increasing intensity and duration of stimulation: Tier1- 2 mA, single 20 min cycle; Tier 2 - 1 mA, 2 cycles of 20 min/20 min off; Tier 3- 2mA, 2 cycles of 20 min/20 min off; Tier 4 - 1 mA, 3 cycles of 20min/20 min off; Tier 5 - 2 mA, 3 cycles of 20 min/20 min off. The decision to which dose Tier the patient should be assigned will be determined by the mathematical Bayesian model. |
| Sham stimulation in patients ineligible for intravenous thrombolytic | Sham comparator | Device: Sham tDCSPatients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation. |
| Transcranial Direct Current Stimulation in patients receiving intravenous thrombolytic | Active comparator | Device: High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS)Patients in the active stimulation group receive cathodal transcranial electrical stimulation via 5 small electrodes for 20 to 60 minutes (min) at 1 or 2 milliamperes (mA) intensities. The duration and intensity of the stimulation will determined by the dose Tier the patient is assigned to. There will be 5 dose tiers, reflecting increasing intensity and duration of stimulation: Tier1- 2 mA, single 20 min cycle; Tier 2 - 1 mA, 2 cycles of 20 min/20 min off; Tier 3- 2mA, 2 cycles of 20 min/20 min off; Tier 4 - 1 mA, 3 cycles of 20min/20 min off; Tier 5 - 2 mA, 3 cycles of 20 min/20 min off. The decision to which dose Tier the patient should be assigned will be determined by the mathematical Bayesian model. |
| Sham stimulation in patients receiving intravenous thrombolytic | Sham comparator | Device: Sham tDCSPatients in the sham stimulation arm will have the cap and electrodes in place but will not receive electrical stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-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. | Device | Transcranial Direct Current Stimulation in patients ineligible for intravenous thrombolytic, Transcranial Direct Current Stimulation in patients receiving intravenous thrombolytic |
| Sham tDCSSham patients will have cap and electrodes in place, but no stimulation will be delivered. | Device | Sham stimulation in patients ineligible for intravenous thrombolytic, Sham stimulation in patients receiving intravenous thrombolytic |
Primary outcome
Presence of Radiographic Intracranial Hemorrhage
Time frame: At 24-30 hour post-stimulation
Presence of any intracranial hemorrhage on brain MRI, including hemorrhagic infarction types 1,2 and parenchymal hematoma types 1 and 2.
Presence of Substantial Penumbra Salvage
Time frame: At 24-30 hour post-stimulation
Presence of substantial penumbra salvage on hemodynamic brain MRI is defined as the presence of salvage of more than equal to 40% of penumbra.
8 secondary outcomes
Frequency of Symptomatic Intracranial Hemorrhage-Safety Outcome
Time frame: At 24-30 hour post-stimulation
Frequency of Early Neurologic Deterioration-Safety Outcome
Time frame: At 24-hour post-stimulation
All-cause Mortality -Safety Outcome
Time frame: At day 90 post-stimulation
Frequency of Completion of Stimulation Protocol-Tolerability Outcome
Time frame: At the end of each 20 minute stimulation period
Frequency and Severity of Adverse Events-Tolerability Outcome
Time frame: At the end of each 20 minute stimulation period
Amount of Collateral Enhancement- Imaging Efficacy Biomarker Outcome
Time frame: At 24-30 hour post-stimulation
Infarct Core Growth- Imaging Efficacy Biomarker Outcome
Time frame: At 24-30 hour post-stimulation
Reduction in Ischemic Lesion- Imaging Efficacy Biomarker Outcome
Time frame: At 24-30 hour post-stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-definition Cathodal Transcranial Direct Current Stimulation (HD C-tDCS) in people with Acute Ischemic Stroke, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mersedeh Bahr-Hosseini, MD (310-794-1195, MBahrHosseini@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Radiographic Intracranial Hemorrhage (time frame: At 24-30 hour post-stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.