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

Acute Ischemic Stroke Clinical Trial

— TESSERACT-BA  

Official title:

Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial_ Bridging and Adjunctive Neuroprotection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04061577
• Other study ID #: 19-000529
• Status: Terminated
• Phase: N/A
• Start date: July 28, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)
20 minutes of Cathodal tDCS after +/- before endovascular thrombectomy (EVT)

Locations

Country	Name	City	State
United States	University of California- Los Angeles (UCLA)	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Change in the penumbral volume between the timepoints: baseline, 2- hour, and 24-hour post-stimulation
Other	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.	At day-90 post stimulation
Primary	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	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	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	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.	At 24-hour post-stimulation
Secondary	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.	At 24-hour post-stimulation
Secondary	Secondary Safety Outcome-Number of Participants With Mortality	Rate of mortality	At 90 days post-stimulation
Secondary	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.	At 90 days post-stimulation