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

Not Applicable

Recruiting

• Conditions: Transcranial Direct Current Stimulation

• Registration Number: NCT05628818
• Lead Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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:

  1. Pacemaker.
  2. Electrical and/or metallic implants.
  3. Pregnancy.
  4. Anticonvulsant medication.
  5. Tattoos in the area of electrode placement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Digit Span test	Post intervention: Six months after intervention	Evaluates working memory. Normal average reference: to have a digit span of 7 items (plus or minus 2), the greater the memory span, the better the result.
Montreal cognitive assessment	Post intervention: Six months after intervention	Global cognitive assessment test that incorporates the evaluation of executive domains such as working memory, inhibition and others such as verbal fluency, delayed recall and visuospatial capacity
Five digit test	Post intervention: Six months after intervention	Assessing inhibitory control. A numerical task divided into four components. The first component (reading) demands subjects to name numbers from 1 to 5 as fast as they can. On the second component (counting), they need to describe quantities from 1 to 5. The third component (choosing) involves a selective attention trial, where the subjects must not read the numbers, but rather tell how many numbers are present in each stimulus, in an incongruent condition. The last component (shifting) is similar to the choosing trial, but for each of the five stimuli, there is one previously where the subject must read the stimulus numbers. The test total scores will be used as the main measure in this study. Higher scores indicate worse performance.
Wisconsin Card Sorting Test, Brief version.	Post intervention: Six months after intervention	Assess cognitive flexibility. Respondents are required to sort numbered response cards according to different principles and to alter their approach during test administration. The global number of categories achieved will be assesed, the greater, the better the result is.

Secondary Outcome Measures

Name	Time	Method
modified rankin scale	Post intervention: 12 months after intervention	Functional assessment scale ranging from 0 (independent) to 6 (death)
Return to work	Post intervention: 12 months after intervention	To determine whether the patient has been able to return to the previous job
Beck's Depression Inventory	Post intervention: Six months after intervention	Evaluation of depression ranging from 0 to 63. A score \> 20: significant depression
Apathy Evaluation Scale	Post intervention: Six months after intervention	Evaluation of presence of apathy. Consists of 18 specific items to quantify apathy within a scoring range of 18 to 72. The greater the score, the greater the apathy symptoms.
WHOQOL-BREF scale	Post intervention: Six months after intervention	Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.

Trial Locations

Locations (1)

Torrecardenas University Hospital; 🇪🇸 Almería, Almeria, Spain