Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke

Not Applicable

Completed

Interventions: Device: Transcranial Direct Current Stimulation
Other: Sham Stimulation

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 who are ineligible for intravenous thrombolysis and 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 not eligible for blood flow restoring recanalization procedures. 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.

The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation
Sham Stimulation	Sham Stimulation	Sham Stimulation

Primary Outcome Measures

Name	Time	Method
Safety Outcome: Rate of Symptomatic Intracranial Hemorrhage (SICH) in the Active Treatment Arms Compared to Sham Arm	At 24-hour post-stimulation	The presence of SICH will be assessed on 24-hour post-stimulation scan. SICH will be defined as an intracranial parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage with an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) within 24 hours of stimulation.The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham. The NIHSS is a validated quantitative assessment tool to measure stroke-related neurological deficits and ranges from 0 (no neurological deficits) to a maximum of 42, indicative of a very severe level of impairment.
Feasibility Outcome: Speed With Which HD C-tDCS Was Implemented	Time from randomization to tDCS initiation assessed up to 30 minutes	The median time from enrollment to HD C-tDCS initiation in the last 4 enrolled patients included three Active-Tier 2 patients and one sham.
Tolerability Outcome: Percentage of the Patients Completing the Protocol-assigned Stimulation Treatment	After 20 minutes of stimulation period	Percentage of the patients completing the protocol-assigned stimulation treatment

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Outcome: Rate of Early Neurologic Deterioration in All Active Patients Compared to Sham Arm	During the 24-hour post-stimulation	Early neurological deterioration will be defined as worsening ≥ 4 on NIHSS during the 24-hour period after stimulation without intracranial hemorrhage.
Secondary Safety Outcome: Rate of Mortality in All Active Patients Compared to Sham Arm,	By day 90 post stimulation	Mortality will be defined as death or modified Rankin Scale of 6.
Secondary Safety Outcome: Rate of All Serious Adverse Events Occured During the 90 Days of Study Participation in All Active Patients Compared to Sham.	By day 90 post-stimulation	A serious adverse event 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. The rate of serious adverse events will be compared between the active treatment and sham patients.

Locations (1): University of California- Los Angeles (UCLA)
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Los Angeles, California, United States