An interventional study of Transcranial Direct Current Stimulation (tDCS) in Acute Ischemic Stroke, sponsored by University of California, Los Angeles. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion before and after endovascular therapy.
This is a single-center, sham-controlled, dose-escalation study where cathodal tDCS is delivered to threatened but not yet irreversibly damaged (penumbral) tissue in patients with large vessel occlusion who are undergoing recanalization procedure. Patients will be randomized in a 3:1 design, to cathodal versus sham (control) stimulation, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. All patients will be receiving the first dose (stimulation cycle) after the recanalization procedure and patients at dose tiers 5-6 will also be receiving stimulation cycles before the recanalization procedure begins.
The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion criteria
Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers: Tier 1 - 1 mA, and Tier 2- 2 mA: Consist of a single stimulation cycle (20min) after the endovascular procedure (EVT) in patients with TICI\<2c,3 and negative immediate post-EVT CT scan for definitive evidence of ICH. Tier 3 - 1 mA and Tier 4- 2mA consist of 2 treatment cycles after the EVT in patients with TICI\<2c and 3, and negative immediate post-EVT CT scan for definitive evidence of ICH. Tier 5 - 1 mA and tier 6- 2 mA consist of 3 treatment cycles. The first cycle will be up to 20 min cycle, after initial imaging and prior to arterial puncture, the second and third cycles after EVT in patients with TICI\<2c and 3 and negative immediate post-EVT CT scan for definitive evidence of ICH.
Device: Transcranial Direct Current Stimulation (tDCS)
Patients in the sham stimulation arm at all the tiers will have the cap and electrodes in place, and sham switch moved but without delivery of electrical stimulation.
Device: Transcranial Direct Current Stimulation (tDCS)
20 minutes of Cathodal tDCS after +/- before endovascular thrombectomy (EVT)
Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)
Symptomatic intracranial hemorrhage (SICH) is defined as an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) total score within 24 hours of stimulation associated with parenchymal hematoma type 1 (PH1), parenchymal hematoma type 2 (PH2), remote intraparenchymal hemorrhage (RIH), subarachnoid hemorrhage (SAH), or intraventricular hemorrhage (IVH). The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Time frame: At 24-hour post-stimulation
Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation
The percentage of the patients completing the protocol-assigned stimulation treatment with no intolerability.
Time frame: After 5 minutes of stimulation period
Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization.
The median times from randomization to bridging C-tDCS initiation and the time form end of endovascular thrombectomy procedure to adjunctive C-tDCS initiation in the last 10 enrolled patients.
Time frame: Median time from randomization to tDCS initiation
Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)
AICH is defined as intracranial hemorrhage not associated with National Institute of Health Stroke Scale (NIHSS) total score worsening of ≥ 4. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Time frame: At 24-hour post-stimulation
Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration
Worsening of total score ≥ 4 on NIHSS during the 24-hour period after stimulation, with or without intracranial hemorrhage. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Time frame: At 24-hour post-stimulation
Secondary Safety Outcome-Number of Participants With Mortality
Rate of mortality
Time frame: At 90 days post-stimulation
Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)
A serious adverse event (SAE) is any adverse event that is fatal, is life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or requires medical or surgical intervention to prevent one of the above outcomes. Anticipated serious adverse events were defined as SAEs that are expected and related to acute ischemic stroke complications such as headache, stroke recurrence, pneumonia, systemic blood clots, Family withdrawal of care, etc. An unanticipated serious adverse event is an SAE that is not deemed an ischemic stroke complication and adjudicated as possibly related to study treatment.
Time frame: At 90 days post-stimulation
Exploratory Imaging Efficacy Outcome- Assessing Imaging Biomarker of Neuroprotection and Collateral Enhancement
By comparing the baseline MR/CT imaging with the MR/CT imaging at 2-hour (early) and 24-hour (final) post-stimulation, the following were planned to be measured: 1) Final penumbra salvage proportion, 2) Final hypoperfusion lesion reduction, 3) Early relative quantitative cerebral blood volume (qrCBV) enhancement.
Time frame: Change in the penumbral volume between the timepoints: baseline, 2- hour, and 24-hour post-stimulation
Exploratory Clinical Efficacy Outcome- Assessing 3 Months Disability
Examining the clinical outcomes of 3-month modified Rankin Scale. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The scale runs from 0-6, running from perfect health without symptoms to death.
Time frame: At day-90 post stimulation
| Milestone | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Started | 1 | 0 |
| Completed | 0 | 0 |
| Not completed | 1 | 0 |
Symptomatic intracranial hemorrhage (SICH) is defined as an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) total score within 24 hours of stimulation associated with parenchymal hematoma type 1 (PH1), parenchymal hematoma type 2 (PH2), remote intraparenchymal hemorrhage (RIH), subarachnoid hemorrhage (SAH), or intraventricular hemorrhage (IVH). The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
| Participants | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH) | 0 | 0 |
The percentage of the patients completing the protocol-assigned stimulation treatment with no intolerability.
| Participants | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation | 1 | — |
The median times from randomization to bridging C-tDCS initiation and the time form end of endovascular thrombectomy procedure to adjunctive C-tDCS initiation in the last 10 enrolled patients.
| minutes | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization. | 12 | — |
AICH is defined as intracranial hemorrhage not associated with National Institute of Health Stroke Scale (NIHSS) total score worsening of ≥ 4. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
| participants | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH) | 0 | — |
Worsening of total score ≥ 4 on NIHSS during the 24-hour period after stimulation, with or without intracranial hemorrhage. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
| Participants | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration | 0 | — |
Rate of mortality
| Participants | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Secondary Safety Outcome-Number of Participants With Mortality | 1 | — |
A serious adverse event (SAE) is any adverse event that is fatal, is life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or requires medical or surgical intervention to prevent one of the above outcomes. Anticipated serious adverse events were defined as SAEs that are expected and related to acute ischemic stroke complications such as headache, stroke recurrence, pneumonia, systemic blood clots, Family withdrawal of care, etc. An unanticipated serious adverse event is an SAE that is not deemed an ischemic stroke complication and adjudicated as possibly related to study treatment.
| Participants | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated) | 1 | — |
By comparing the baseline MR/CT imaging with the MR/CT imaging at 2-hour (early) and 24-hour (final) post-stimulation, the following were planned to be measured: 1) Final penumbra salvage proportion, 2) Final hypoperfusion lesion reduction, 3) Early relative quantitative cerebral blood volume (qrCBV) enhancement.
No measurements were reported for this outcome.
Examining the clinical outcomes of 3-month modified Rankin Scale. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The scale runs from 0-6, running from perfect health without symptoms to death.
No measurements were reported for this outcome.
Collected over 90 days after enrollment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Stimulation Arm | 1/1 (100%) | 1/1 (100%) | 0/1 (0%) |
| Sham Arm | — | — | — |
| Event | Active Stimulation Arm | Sham Arm |
|---|---|---|
| Anticipated serious adverse eventsNervous system disorders | 1/1 | — |
| Unanticipated serious adverse eventNervous system disorders | 0/1 | — |
Study was stopped early.
| Age, Continuous(years) | Active Stimulation Arm | Sham Arm | Total |
|---|---|---|---|
| Mean | 95 (95 to 95) | — | 95 (95 to 95) |
| Sex: Female, Male(Participants) | Active Stimulation Arm | Sham Arm | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Active Stimulation Arm | Sham Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 1 | — | 1 |
| White | 0 | — | 0 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
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University of California, Los Angeles