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NCT04801446Completed

Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment

Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment - Safety and Feasibility Trial

Source: ClinicalTrials.gov · Last updated 6 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
25 (actual)
First submitted
5 Jan 2021
Start date
10 May 2021
Primary completion date
13 Nov 2023
Lead sponsor
General University Hospital, Prague
Diseases
Stroke
NCT number
NCT04801446

What you commit to

  • Study type: Interventional
  • Participants enrolled: 25
  • From 10 May 2021 to the primary completion date, 13 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.).
  • Concomitant experimental therapy.

Other illness

  • 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.).
  • 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.
  • History of acute overdose by DOAC.
  • Known congenital or acquired increased bleeding propensity.
  • Known CT iodine contrast allergy.
  • Signs or symptoms of acute myocardial infarction, including ECG findings, 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.

Lab values

  • INR \> 3,0.
  • Heparin or LMWH therapy in last 48 hours with aPTT increased more than 1,5 times over limit of the laboratory.
  • Known renal dysfunction (eGFR\<30 ml/min.).

Other

  • Evidence of a large Ischemic core volume on baseline CTP: volume of rCBF\<30% ≥ 100ml.
  • Subacute or chronic subdural hematoma or hygroma.
  • Thrombocytopenia \< 100 000/ul.
  • Suspected or confirmed pregnancy.
  • Suspicion of aortic dissection on admission.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Neurology, General University Hospital in Prague
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.