Transcranial Direct Current StimulationMODUL-EXENCT05628818
Noninvasive Transcranial Direct Current Stimulation to Improve Executive Functions in Stroke Patients. MODUL-EXE Clinical Trial.
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Transcranial Direct Current Stimulation, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transcranial Direct Current Stimulation
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- Failure to meet any of the inclusion criteria recorded in the Screening for electrical stimulation of the University of Göttingen.
- Presence of:
- Pacemaker.
- Electrical and/or metallic implants.
- Pregnancy.
- Anticonvulsant medication.
- Tattoos in the area of electrode placement.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Torrecardenas University Hospital
Almería, Almeria, 04009
Laura. Amaya Pascasio, M.D., 605965362, laura.amaya.pascasio@gmail.com
Patricia Martinez Sanchez, PhD, patrinda@ual.es
About this study
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.
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
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct current Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham Transcranial Direct current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Transcranial Direct current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post intervention: Six months after intervention
Secondary outcomes (21)
modified rankin scale
Functional assessment scale ranging from 0 (independent) to 6 (death)
Measured: Evaluation immediately post intervention
modified rankin scale
Functional assessment scale ranging from 0 (independent) to 6 (death)
Measured: Evaluation post intervention: One month after intervention
modified rankin scale
Functional assessment scale ranging from 0 (independent) to 6 (death)
Measured: Post intervention: Three months after intervention
modified rankin scale
Functional assessment scale ranging from 0 (independent) to 6 (death)
Measured: Post intervention: Six months after intervention
modified rankin scale
Functional assessment scale ranging from 0 (independent) to 6 (death)
Measured: Post intervention: 12 months after intervention
Return to work
To determine whether the patient has been able to return to the previous job
Measured: Post intervention: One month after intervention
Return to work
To determine whether the patient has been able to return to the previous job
Measured: Post intervention: Three months after intervention
Return to work
To determine whether the patient has been able to return to the previous job
Measured: Post intervention: 6 months after intervention
Return to work
To determine whether the patient has been able to return to the previous job
Measured: Post intervention: 12 months after intervention
Beck's Depression Inventory
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression (moderate-severe)
Measured: Evaluation immediately post intervention
Beck's Depression Inventory
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression
Measured: Post intervention: One month after intervention
Beck's Depression Inventory
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression
Measured: Post intervention: Three months after intervention
Beck's Depression Inventory
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression
Measured: Post intervention: Six months after intervention
Apathy Evaluation Scale
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.
Measured: Evaluation immediately post intervention
Apathy Evaluation Scale
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.
Measured: Post intervention: One month after intervention
Apathy Evaluation Scale
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.
Measured: Post intervention: Three months after intervention
Apathy Evaluation Scale
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.
Measured: Post intervention: Six months after intervention
WHOQOL-BREF scale
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
Measured: Evaluation immediately post intervention
WHOQOL-BREF scale
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
Measured: Post intervention: One month after intervention
WHOQOL-BREF scale
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
Measured: Post intervention: Three months after intervention
WHOQOL-BREF scale
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
Measured: Post intervention: Six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 Feb 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad de Almeria
- Responsible party
- Principal investigator, Laura Amaya Pascasio, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Investigators
- Patricia Martinez Sanchez, PhD, Principal investigator, Torrecardenas University HospitalPilar Flores Cubos, Professor, PhD, Study director, Department of Psychology. University of Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628818
- Sponsor's protocol ID
- MODUL-EXE
- Acronym
- MODUL-EXE
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Amaya-Pascasio L, Garcia-Pinteno J, Sanchez-Kuhn A, Uceda Sanchez C, Fernandez-Martin P, Leon Domene JJ, Rodriguez-Herrera R, Flores P, Martinez-Sanchez P. Neuromodulation of Executive Dysfunction in Patients with Acute Stroke Using Transcranial Direct Current Stimulation: Study Protocol for a Triple-Blind, Randomized Sham-Controlled Trial. Cerebrovasc Dis. 2024;53(3):335-345. doi: 10.1159/000531860. Epub 2023 Jul 20.
PubMed 39250901
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05628818
- Acronym / sponsor ID
- MODUL-EXE / MODUL-EXE
- Conditions
- Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad de Almeria
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS combined with cognitive training, stroke patients | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)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. |
| Sham tDCS combined with cognitive training, stroke patients | Sham comparator | Device: Sham Transcranial Direct current StimulationTo 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Anodal tDCS combined with cognitive training, stroke patients |
| Sham Transcranial Direct current StimulationSham 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. | Device | Sham tDCS combined with cognitive training, stroke patients |
Primary outcome
Montreal cognitive assessment
Time frame: Evaluation immediately post 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. Maximum score: 30. Normal if score > 26.
Montreal cognitive assessment
Time frame: Evaluation post intervention: One month 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
Montreal cognitive assessment
Time frame: Post intervention: Three 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
Montreal cognitive assessment
Time frame: 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
Digit Span test
Time frame: Evaluation immediately post 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.
Digit Span test
Time frame: Evaluation post intervention: One month 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.
Digit Span test
Time frame: Post intervention: Three 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.
Digit Span test
Time frame: 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.
Wisconsin Card Sorting Test, Brief version.
Time frame: Evaluation immediately post 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.
Wisconsin Card Sorting Test, Brief version.
Time frame: Evaluation post intervention: One month 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.
Wisconsin Card Sorting Test, Brief version.
Time frame: Post intervention: Three 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.
Wisconsin Card Sorting Test, Brief version.
Time frame: 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.
Five digit test
Time frame: Evaluation immediately post 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.
Five digit test
Time frame: Evaluation post intervention: One month 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.
Five digit test
Time frame: Post intervention: Three 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.
Five digit test
Time frame: 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.
21 secondary outcomes
modified rankin scale
Time frame: Evaluation immediately post intervention
modified rankin scale
Time frame: Evaluation post intervention: One month after intervention
modified rankin scale
Time frame: Post intervention: Three months after intervention
modified rankin scale
Time frame: Post intervention: Six months after intervention
modified rankin scale
Time frame: Post intervention: 12 months after intervention
Return to work
Time frame: Post intervention: One month after intervention
Return to work
Time frame: Post intervention: Three months after intervention
Return to work
Time frame: Post intervention: 6 months after intervention
Return to work
Time frame: Post intervention: 12 months after intervention
Beck's Depression Inventory
Time frame: Evaluation immediately post intervention
Beck's Depression Inventory
Time frame: Post intervention: One month after intervention
Beck's Depression Inventory
Time frame: Post intervention: Three months after intervention
Beck's Depression Inventory
Time frame: Post intervention: Six months after intervention
Apathy Evaluation Scale
Time frame: Evaluation immediately post intervention
Apathy Evaluation Scale
Time frame: Post intervention: One month after intervention
Apathy Evaluation Scale
Time frame: Post intervention: Three months after intervention
Apathy Evaluation Scale
Time frame: Post intervention: Six months after intervention
WHOQOL-BREF scale
Time frame: Evaluation immediately post intervention
WHOQOL-BREF scale
Time frame: Post intervention: One month after intervention
WHOQOL-BREF scale
Time frame: Post intervention: Three months after intervention
WHOQOL-BREF scale
Time frame: Post intervention: Six months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 39250901Amaya-Pascasio L, Garcia-Pinteno J, Sanchez-Kuhn A, Uceda Sanchez C, Fernandez-Martin P, Leon Domene JJ, Rodriguez-Herrera R, Flores P, Martinez-Sanchez P. Neuromodulation of Executive Dysfunction in Patients with Acute Stroke Using Transcranial Direct Current Stimulation: Study Protocol for a Triple-Blind, Randomized Sham-Controlled Trial. Cerebrovasc Dis. 2024;53(3):335-345. doi: 10.1159/000531860. Epub 2023 Jul 20.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Martinez Sanchez, PhD principal investigator
Torrecardenas University Hospital
Pilar Flores Cubos, Professor, PhD study director
Department of Psychology. University of Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Transcranial Direct Current Stimulation, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Amaya Pascasio, MD (+34 950016860, laura.amaya.pascasio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal cognitive assessment (time frame: Evaluation immediately post intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.