Clinical trial NCT05628818: Noninvasive Transcranial Direct Current Stimulation to Improve Executive Functions in Stroke Patients. MODUL-EXE Clinical Trial.
Official title: Neuromodulation of Executive Dysfunction in Patients With Acute Stroke Using Transcranial Direct Current Stimulation. A Randomized-triple Blinded Controlled Clinical Trial. MODUL-EXE Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Lead sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Universidad de Almeria
First posted: 2022-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Montreal cognitive assessment
timeFrame: Evaluation immediately post intervention
measure: Montreal cognitive assessment
timeFrame: Evaluation post intervention: One month after intervention
measure: Montreal cognitive assessment
timeFrame: Post intervention: Three months after intervention
measure: Montreal cognitive assessment
timeFrame: Post intervention: Six months after intervention
measure: Digit Span test
timeFrame: Evaluation immediately post intervention
measure: Digit Span test
timeFrame: Evaluation post intervention: One month after intervention
measure: Digit Span test
timeFrame: Post intervention: Three months after intervention
measure: Digit Span test
timeFrame: Post intervention: Six months after intervention
measure: Wisconsin Card Sorting Test, Brief version.
timeFrame: Evaluation immediately post intervention
measure: Wisconsin Card Sorting Test, Brief version.
timeFrame: Evaluation post intervention: One month after intervention
measure: Wisconsin Card Sorting Test, Brief version.
timeFrame: Post intervention: Three months after intervention
measure: Wisconsin Card Sorting Test, Brief version.
timeFrame: Post intervention: Six months after intervention
measure: Five digit test
timeFrame: Evaluation immediately post intervention
measure: Five digit test
timeFrame: Evaluation post intervention: One month after intervention
measure: Five digit test
timeFrame: Post intervention: Three months after intervention
measure: Five digit test
timeFrame: Post intervention: Six months after intervention
Secondary outcomes:
measure: modified rankin scale
timeFrame: Evaluation immediately post intervention
measure: modified rankin scale
timeFrame: Evaluation post intervention: One month after intervention
measure: modified rankin scale
timeFrame: Post intervention: Three months after intervention
measure: modified rankin scale
timeFrame: Post intervention: Six months after intervention
measure: modified rankin scale
timeFrame: Post intervention: 12 months after intervention
measure: Return to work
timeFrame: Post intervention: One month after intervention
measure: Return to work
timeFrame: Post intervention: Three months after intervention
measure: Return to work
timeFrame: Post intervention: 6 months after intervention
measure: Return to work
timeFrame: Post intervention: 12 months after intervention
measure: Beck's Depression Inventory
timeFrame: Evaluation immediately post intervention
measure: Beck's Depression Inventory
timeFrame: Post intervention: One month after intervention
measure: Beck's Depression Inventory
timeFrame: Post intervention: Three months after intervention
measure: Beck's Depression Inventory
timeFrame: Post intervention: Six months after intervention
measure: Apathy Evaluation Scale
timeFrame: Evaluation immediately post intervention
measure: Apathy Evaluation Scale
timeFrame: Post intervention: One month after intervention
measure: Apathy Evaluation Scale
timeFrame: Post intervention: Three months after intervention
measure: Apathy Evaluation Scale
timeFrame: Post intervention: Six months after intervention
measure: WHOQOL-BREF scale
timeFrame: Evaluation immediately post intervention
measure: WHOQOL-BREF scale
timeFrame: Post intervention: One month after intervention
measure: WHOQOL-BREF scale
timeFrame: Post intervention: Three months after intervention
measure: WHOQOL-BREF scale
timeFrame: Post intervention: Six months after intervention
Other outcomes:
measure: Change in resting state functional connectivity
timeFrame: Evaluation immediately post intervention
measure: Change in resting state functional connectivity
timeFrame: Post intervention: One month after intervention
measure: Change in resting state functional connectivity
timeFrame: Post intervention: Three months after intervention
measure: Change in resting state functional connectivity
timeFrame: Post intervention: Six months after intervention
measure: Motor evaluation
timeFrame: Evaluation immediately post intervention
measure: Motor evaluation
timeFrame: Post intervention: One month after intervention
measure: Motor evaluation
timeFrame: Post intervention: Three months after intervention
measure: Motor evaluation
timeFrame: Post intervention: Six months after intervention
measure: Blood biomarkers
timeFrame: Evaluation immediately post intervention
Locations:
city: Almería
country: Spain
facility: Torrecardenas University Hospital
state: Almeria
Study officials:
affiliation: Torrecardenas University Hospital
name: Patricia Martinez Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology. University of Almeria
name: Pilar Flores Cubos, Professor, PhD
role: STUDY_DIRECTOR
References: