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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Transcranial Direct Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anodal tDCS combined with cognitive training, stroke patients

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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

Sham tDCS combined with cognitive training, stroke patients

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.

Group Type SHAM_COMPARATOR

Sham Transcranial Direct current Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

* Presence of:

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No