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

NCT04061577 | Terminated Results DMC FDA Device

• 1 other identifier: 19-000529
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Transcranial direct current stimulation; Bridging neuroprotection; Adjunctive neuroprotection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Median time from randomization to tDCS initiation

Secondary Outcomes (4)

• Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)

  At 24-hour post-stimulation

• Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration

  At 24-hour post-stimulation

• Secondary Safety Outcome-Number of Participants With Mortality

  At 90 days post-stimulation

• Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)

  At 90 days post-stimulation

Other Outcomes (2)

• Exploratory Imaging Efficacy Outcome- Assessing Imaging Biomarker of Neuroprotection and Collateral Enhancement

  Change in the penumbral volume between the timepoints: baseline, 2- hour, and 24-hour post-stimulation

• Exploratory Clinical Efficacy Outcome- Assessing 3 Months Disability

  At day-90 post stimulation

Study Arms (2)

Stimulation arm

EXPERIMENTAL

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)

Sham arm

SHAM COMPARATOR

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)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

20 minutes of Cathodal tDCS after +/- before endovascular thrombectomy (EVT)

Sham arm; Stimulation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• The City College of New York: collaborator

Study Sites (1)

University of California- Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Mersedeh Bahr Hosseini
• Organization: UCLA

MBahrHosseini@mednet.ucla.edu

3107941195

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Traditional 3+3 (rule-based, modified Fibonacci) dose-escalation design

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 20, 2019
• Study Start: July 28, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-06

Locations

US (1)