Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment

NCT ID: NCT04801446

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2024-02-10

Brief Summary

This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for endovascular therapy (EVT). Patients will be randomized in a 3:1 design, to cathodal versus sham (control) tDCS, 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Transcranial Direct Current Stimulation

Group Type: ACTIVE_COMPARATOR

Soterix Medical 1X1 tDCS stimulator (active C-tDCS)

Intervention Type: DEVICE

Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers, reflecting increasing intensity and duration of stimulation: Tier 1 - 1 mA, single 20 - min cycle; Tier 2- 2 mA, single 20 min cycle; Tier 3 - 1 mA, 2 cycles of 20 min/20 min off; Tier 4- 2 mA, 2 cycles of 20 min/20 min off; Tier 5 - 1 mA, 3 cycles of 20 min/20 min off; Tier 6 - 2 mA, 3 cycles of 20 min/20 min off.

Sham Stimulation

Group Type: SHAM_COMPARATOR

Soterix Medical 1X1 tDCS stimulator (sham stimulation)

Intervention Type: DEVICE

Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. Patients in the sham stimulation arm at all the tiers will have the headgear and electrodes in place, and the switch for sham stimulation will be on, i.e. no prolonged electrical stimulation will be delivered.

Interventions

Soterix Medical 1X1 tDCS stimulator (active C-tDCS)

Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers, reflecting increasing intensity and duration of stimulation: Tier 1 - 1 mA, single 20 - min cycle; Tier 2- 2 mA, single 20 min cycle; Tier 3 - 1 mA, 2 cycles of 20 min/20 min off; Tier 4- 2 mA, 2 cycles of 20 min/20 min off; Tier 5 - 1 mA, 3 cycles of 20 min/20 min off; Tier 6 - 2 mA, 3 cycles of 20 min/20 min off.

Intervention Type: DEVICE

Soterix Medical 1X1 tDCS stimulator (sham stimulation)

Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. Patients in the sham stimulation arm at all the tiers will have the headgear and electrodes in place, and the switch for sham stimulation will be on, i.e. no prolonged electrical stimulation will be delivered.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years.
• New focal neurologic deficit consistent with acute ischemic stroke.
• Baseline NIHSS ≥ 4 or NIHSS < 4 in the presence of disabling deficits (e.g. aphasia)
• Presence of acute occlusion of ICA or MCA (including MCA peripheral cortical branches) according to clinical picture and baseline CTA/CTP scan.
• Presence of salvageable penumbra with Tmax > 6 sec/ ischemic core volume (rCBF < 30%) ≥ 1.2 on baseline CTP scan.
• Patient is ineligible for EVT per current national guidelines (Cerebrovascular Section of Czech Neurological Society ČLS JEP).
• Subject is able to be treated with tDCS within 24 hours of last known well time.
• A signed informed consent is obtained from the patient or patient's legally authorized representative (point 30 of Declaration of Helsinki).

Exclusion Criteria

• Acute intracranial hemorrhage including suspected subarachnoid hemorrhage.
• Other than ischemic cause of acute neurological deficit (stroke mimics:postparoxysmal Todd´s palsy, metabolic cause, tumor, meningoencephalitis etc.).
• Evidence of a large Ischemic core volume on baseline CTP: volume of rCBF<30% ≥ 100ml.
• Subacute or chronic subdural hematoma or hygroma.
• Intra-axial malignant brain tumor.
• History of spontaneous ICH in the past.
• History of seizure disorder or new seizures with presentation of current stroke.
• History of intracranial surgery.
• Presence of tDCS contraindications: skin lesion at the site of stimulation (open wound, acute inflammation of skin or subcutaneous tissue, burns etc.); skull defect at the site of stimulation (e.g. skull fracture, postcraniectomy); implanted electric device (pacemaker, ICD, DBS, cochlear implant etc.); presence of metal material in head (e.g. metal stent, clamps etc.).
• Thrombocytopenia < 100 000/ul.
• INR > 3,0.
• Heparin or LMWH therapy in last 48 hours with aPTT increased more than 1,5 times over limit of the laboratory.
• History of acute overdose by DOAC.
• Known congenital or acquired increased bleeding propensity.
• Suspected or confirmed pregnancy.
• Known CT iodine contrast allergy.
• Known renal dysfunction (eGFR<30 ml/min.).
• Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
• Suspicion of aortic dissection on admission.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Matej Slovak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General University Hospital in Prague

Prague, , Czechia

Countries

Czechia

Other Identifiers

1786/20 S-IV

Identifier Type: -

Identifier Source: org_study_id