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Noninvasive Transcranial Direct Current Stimulation to Improve Executive Functions in Stroke Patients. MODUL-EXE Clinical Trial.

NCT05628818 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-01-18

No results posted yet for this study

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.

Conditions

  • Transcranial Direct Current Stimulation

Interventions

DEVICE

Transcranial Direct Current Stimulation (tDCS)

Real anodal tDCS over the left dorsolateral prefrontal cortex in acute stroke patients to improve dysexecutive syndrome. Intensity: 2 mA. Stimulation period: 20 minutes.

DEVICE

Sham Transcranial Direct current Stimulation

Sham anodal tDCS over the left dorsolateral prefrontal cortex: anodal tDCS. Intensity: 2 mA. Stimulation period: 1 minute. Afterwards, the device will automatically shut down but the sham stimulation period will last a total of 20 minutes.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Universidad de Almeria

    collaborator OTHER

  • Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

    lead OTHER

Principal Investigators

  • Patricia Martinez Sanchez, PhD · Torrecardenas University Hospital

  • Pilar Flores Cubos, Professor, PhD · Department of Psychology. University of Almeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-12-30
Completion
2024-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628818 on ClinicalTrials.gov