Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy

Not Applicable

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT04061577
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study Start: 2019-07-28
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-20
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Results First Submitted: 2023-03-15
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Results First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sham arm	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.
Stimulation arm	Transcranial Direct Current Stimulation (tDCS)	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)	At 24-hour post-stimulation	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.
Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation	After 5 minutes of stimulation period	The percentage of the patients completing the protocol-assigned stimulation treatment with no intolerability.
Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization.	Median time from randomization to tDCS initiation	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)	At 90 days post-stimulation	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.
Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)	At 24-hour post-stimulation	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.
Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration	At 24-hour post-stimulation	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.
Secondary Safety Outcome-Number of Participants With Mortality	At 90 days post-stimulation	Rate of mortality

Trial Locations

Locations (1)

University of California- Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States