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

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Status: Enrolling

Conditions: Transcranial Direct Current Stimulation

Treatments: Device: Sham Transcranial Direct current Stimulation; Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05628818

MODUL-EXE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Anodal tDCS combined with cognitive training, stroke patients

Experimental group

Description:

To stimulate the left DLPFC, the anode electrode will be placed over F3 and the cathode will be placed over the right supraorbital region (Fp2). Each stimulation will be applied for 20 min at 2mA intensity. Stimulation will be continued with the performance of three cognitive training exercises specifically designed to improving working memory, inhibitory control and cognitive flexibility.

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS combined with cognitive training, stroke patients

Sham Comparator group

Description:

To stimulate the left DLPFC, the anode electrode will be placed over F3 and the cathode will be placed over the right supraorbital region (Fp2). Each stimulation will be applied for 1 min at 2mA intensity (sham stimulation). Stimulation will be continued with the performance of three cognitive training exercises specifically designed to improving working memory, inhibitory control and cognitive flexibility.

Treatment:

Device: Sham Transcranial Direct current Stimulation