Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy (TESSERACT-BA)

University of California, Los Angeles (UCLA)

Status: Terminated

Conditions: Acute Ischemic Stroke

Treatments: Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04061577

19-000529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Stimulation arm

Experimental group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Sham arm

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)