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

NCT05628818 | Unknown DMC

• 1 other identifier: MODUL-EXE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (16)

• Montreal cognitive assessment

  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. Maximum score: 30. Normal if score \> 26.

  Evaluation immediately post intervention

• Montreal cognitive assessment

  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

  Evaluation post intervention: One month after intervention

• Montreal cognitive assessment

  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

  Post intervention: Three months after intervention

• Montreal cognitive assessment

  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

  Post intervention: Six months after intervention

• Digit Span test

  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.

  Evaluation immediately post intervention

• Digit Span test

  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.

  Evaluation post intervention: One month after intervention

• Digit Span test

  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.

  Post intervention: Three months after intervention

• Digit Span test

  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.

  Post intervention: Six months after intervention

• Wisconsin Card Sorting Test, Brief version.

  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.

  Evaluation immediately post intervention

• Wisconsin Card Sorting Test, Brief version.

  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.

  Evaluation post intervention: One month after intervention

• Wisconsin Card Sorting Test, Brief version.

  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.

  Post intervention: Three months after intervention

• Wisconsin Card Sorting Test, Brief version.

  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.

  Post intervention: Six months after intervention

• Five digit test

  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.

  Evaluation immediately post intervention

• Five digit test

  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.

  Evaluation post intervention: One month after intervention

• Five digit test

  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.

  Post intervention: Three months after intervention

• Five digit test

  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.

  Post intervention: Six months after intervention

Secondary Outcomes (21)

• modified rankin scale

  Evaluation immediately post intervention

• modified rankin scale

  Evaluation post intervention: One month after intervention

• modified rankin scale

  Post intervention: Three months after intervention

• modified rankin scale

  Post intervention: Six months after intervention

• modified rankin scale

  Post intervention: 12 months after intervention

Other Outcomes (9)

• Change in resting state functional connectivity

  Evaluation immediately post intervention

• Change in resting state functional connectivity

  Post intervention: One month after intervention

• Change in resting state functional connectivity

  Post intervention: Three months after intervention

Study Arms (2)

Anodal tDCS combined with cognitive training, stroke patients

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS combined with cognitive training, stroke patients

SHAM COMPARATOR

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.

Device: Sham Transcranial Direct current Stimulation

Interventions

Transcranial Direct Current Stimulation (tDCS) 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.

Anodal tDCS combined with cognitive training, stroke patients

Sham Transcranial Direct current Stimulation 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.

Sham tDCS combined with cognitive training, stroke patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Presence of:
• Pacemaker.
• Electrical and/or metallic implants.
• Pregnancy.
• Anticonvulsant medication.
• Tattoos in the area of electrode placement.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead
• Instituto de Salud Carlos III: collaborator
• Universidad de Almeria: collaborator

Study Sites (1)

Torrecardenas University Hospital

Almería, Almeria, 04009, Spain

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Patricia Martinez Sanchez, PhD

  Torrecardenas University Hospital

  PRINCIPAL INVESTIGATOR

• Pilar Flores Cubos, Professor, PhD

  Department of Psychology. University of Almeria

  STUDY DIRECTOR

Central Study Contacts

Laura Amaya Pascasio, MD

CONTACT

+34 950016860; laura.amaya.pascasio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, investigator

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 29, 2022
• Study Start: February 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)