Clinical trial NCT04061577: Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy
Official title: Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial_ Bridging and Adjunctive Neuroprotection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Transcranial direct current stimulation
Bridging neuroprotection
Adjunctive neuroprotection
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: The City College of New York
First posted: 2019-08-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Traditional 3+3 (rule-based, modified Fibonacci) dose-escalation design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria

* New focal neurologic deficit consistent with AIS
* Age≥18
* NIHSS ≥ 4
* ICA or M1 or M2 MCA occlusion on pre-thrombectomy MRA or CTA
* Onset (last-seen-well) time to randomization time within 24 hours
* Pre-stroke modified Rankin Scale≤ 3.
* Patient ineligible for IV tPA, per national AHA/ASA Guidelines.
* Having undergone endovascular thrombectomy with less than a complete reperfusion (\<TICI 2c, 3) for receiving post-thrombectomy adjunct C-tDCS.
* Undergoing endovascular thrombectomy, per national AHA/ASA Guidelines for patients who are assigned to pre-thrombectomy bridging session at Tiers 5, 6.
* A signed informed consent is obtained from the patient or patient's legally authorized representative

Exclusion criteria

* Acute intracranial hemorrhage
* Evidence of a large Ischemic core volume (ADC \< 620 µm2/s or rCBF\< 30%) ≥ 100 ml
* Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
* Pregnancy
* Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
* 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, consist of a platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.

Primary outcomes:
measure: Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)
timeFrame: At 24-hour post-stimulation
measure: Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation
timeFrame: After 5 minutes of stimulation period
measure: Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization.
timeFrame: Median time from randomization to tDCS initiation
Secondary outcomes:
measure: Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)
timeFrame: At 24-hour post-stimulation
measure: Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration
timeFrame: At 24-hour post-stimulation
measure: Secondary Safety Outcome-Number of Participants With Mortality
timeFrame: At 90 days post-stimulation
measure: Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)
timeFrame: At 90 days post-stimulation
Other outcomes:
measure: Exploratory Imaging Efficacy Outcome- Assessing Imaging Biomarker of Neuroprotection and Collateral Enhancement
timeFrame: Change in the penumbral volume between the timepoints: baseline, 2- hour, and 24-hour post-stimulation
measure: Exploratory Clinical Efficacy Outcome- Assessing 3 Months Disability
timeFrame: At day-90 post stimulation
Locations:
city: Los Angeles
country: United States
facility: University of California- Los Angeles (UCLA)
state: California
Study officials:
References: