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NCT05628818
Noninvasive Transcranial Direct Current Stimulation to Improve Executive Functions in Stroke Patients. MODUL-EXE Clinical Trial.
Conditions: Transcranial Direct Current Stimulation
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 40
Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Location: Spain
Summary
This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on executive functions in patients with an acute stroke affecting the frontal lobe or the basal ganglia.
The study will include 40 acute stroke subjects.
Participants will undergo a global cognitive assessment with the MoCA test and a specific assessment of executive functions with the abbreviated Wisconsin test, the five digit test and the digit span evaluation (a subtest from the Wechsler intelligence scale for adults-IV).
Participants will then undergo real or sham stimulation with anodal tDCS combined with cognitive training of the main executive functions: working memory, inhibitory control and cognitive flexibility.
After a 10-session intervention, a the baseline cognitive assessment will be repeated and subsequently, a follow-up of up to 12 months will be carried out.
Eligibility Criteria
Inclusion Criteria:Clinical and radiological diagnosis, by means of cranial MRI or CT scan, of ischemic/hemorrhagic stroke, involving the frontal cortex or its subcortical connections (basal ganglia), in one or both hemispheres.The stroke occurred during the 3 months prior to inclusion in the study.Cognitive impairment with a dis-executive profile demonstrated by a score > 26 in the Spanish version of the MoCA test, adjusted for the number of years of formal education.Patients with functional independence prior to the stroke, defined as a modified rankin scale score < 3 points.The patient gives informed consent.Exclusion Criteria:Presence of other pathologies that may be a potential cause of disability or cognitive impairment.Moderate or severe aphasia that hinders communication.Severe sensory and/or motor impairments that prevent the completion of the evaluation and/or intervention processes.Presence of extensive vascular leukopathia (leukoaraiosis grade 3, 4).History of epilepsy or seizures.Presence of severe systemic pathology, including cardiac, hepatic or renal failure, active neoplasia.Failure to meet any of the inclusion criteria recorded in the Screening for electrical stimulation of the University of Göttingen.Presence of:Pacemaker.Electrical and/or metallic implants.Pregnancy.Anticonvulsant medication.Tattoos in the area of electrode placement.
Source: ClinicalTrials.gov (NCT05628818). StuddyBuddy aggregates publicly available trial information.