Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment

NCT04801446 | Completed

• 1 other identifier: 1786/20 S-IV
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; transcranial direct current stimulation; tDCS; neuroprotection

Outcome Measures

Primary Outcomes (1)

• Primary safety outcome: the rate of symptomatic intracranial hemorrhage (SICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.

  The presence of SICH will be assessed on 24-hour post-stimulation non-contrast CT scan. SICH will be defined as an intracranial hemorrhage with an increase of ≥ 4 points on the National Institute of Health Stroke Scale (NIHSS) within 24h after stimulation. In case of sudden worsening of neurostatus anytime within first 24 hours after stimulation, first follow-up CT will be performed immediately (earlier). The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham.

  At 24-hour post-stimulation

Secondary Outcomes (4)

• Secondary safety outcome: the rate of asymptomatic intracranial hemorrhage (AICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.

  At 24-hour post-stimulation

• Secondary safety outcome: the rate of early neurologic deterioration in the active treatment arm compared to sham arm, and between higher and lower dose tiers.

  During the 24-hour post-stimulation

• Secondary safety outcome: the rate of mortality in the active treatment arm compare to sham arm, and between higher and lower dose tiers.

  By day 90 post stimulation

• Secondary safety outcome: the rate of all serious adverse events occurring during the 90 days of study participation in the active treatment arm compare to sham arm, and between higher and lower dose tiers.

  By day 90 post-stimulation

Other Outcomes (9)

• Tolerability outcome: percentage of the patients completing the stimulation

  During procedure

• Tolerability outcome: rate and severity of cutaneous, neurological, nociceptive and other adverse effects

  During procedure

• Feasibility outcome

  During procedure

Study Arms (2)

Transcranial Direct Current Stimulation

ACTIVE COMPARATOR

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

Sham Stimulation

SHAM COMPARATOR

Device: Soterix Medical 1X1 tDCS stimulator (sham stimulation)

Interventions

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

Transcranial Direct Current Stimulation

Soterix Medical 1X1 tDCS stimulator (sham stimulation) 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.

Sham Stimulation

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

Department of Neurology, General University Hospital in Prague

Prague, 12000, Czechia

Location

Related Publications (1)

• Slovak M, Kemlink D, Dusek P, Rekova P, Fabian V, Jurka M, Carone D, Perry A, Harston GWJ, Ruzicka E, Altmanova D, Lambert L, Burgetova A, Knotkova H, Datta A, Bikson M, Nitsche MA, Bahr-Hosseini M, Saver JL. Transcranial direct current stimulation is safe and feasible in hyperacute ischemic stroke (DICAST-SF trial). Neurotherapeutics. 2026 Feb 1:e00844. doi: 10.1016/j.neurot.2026.e00844. Online ahead of print.

  PMID: 41629171 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: March 17, 2021
• Study Start: May 10, 2021
• Primary Completion: November 13, 2023
• Study Completion: February 10, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)