Noninvasive Transcranial Direct Current Stimulation to Improve Executive Functions in Stroke Patients. MODUL-EXE Clinical Trial.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
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| Sham Comparator: 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. |
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.
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Outcome Measures
Primary Outcome Measures
- Montreal cognitive assessment [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 [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 [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 [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 [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 [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 [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 [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. [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. [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. [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. [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 [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 [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 [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 [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.
Secondary Outcome Measures
- modified rankin scale [Evaluation immediately post intervention]
Functional assessment scale ranging from 0 (independent) to 6 (death)
- modified rankin scale [Evaluation post intervention: One month after intervention]
Functional assessment scale ranging from 0 (independent) to 6 (death)
- modified rankin scale [Post intervention: Three months after intervention]
Functional assessment scale ranging from 0 (independent) to 6 (death)
- modified rankin scale [Post intervention: Six months after intervention]
Functional assessment scale ranging from 0 (independent) to 6 (death)
- modified rankin scale [Post intervention: 12 months after intervention]
Functional assessment scale ranging from 0 (independent) to 6 (death)
- Return to work [Post intervention: One month after intervention]
To determine whether the patient has been able to return to the previous job
- Return to work [Post intervention: Three months after intervention]
To determine whether the patient has been able to return to the previous job
- Return to work [Post intervention: 6 months after intervention]
To determine whether the patient has been able to return to the previous job
- Return to work [Post intervention: 12 months after intervention]
To determine whether the patient has been able to return to the previous job
- Beck's Depression Inventory [Evaluation immediately post intervention]
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression (moderate-severe)
- Beck's Depression Inventory [Post intervention: One month after intervention]
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression
- Beck's Depression Inventory [Post intervention: Three months after intervention]
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression
- Beck's Depression Inventory [Post intervention: Six months after intervention]
Evaluation of depression ranging from 0 to 63. A score > 20: significant depression
- Apathy Evaluation Scale [Evaluation immediately post intervention]
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.
- Apathy Evaluation Scale [Post intervention: One month after intervention]
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.
- Apathy Evaluation Scale [Post intervention: Three months after intervention]
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.
- Apathy Evaluation Scale [Post intervention: Six months after intervention]
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.
- WHOQOL-BREF scale [Evaluation immediately post intervention]
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
- WHOQOL-BREF scale [Post intervention: One month after intervention]
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
- WHOQOL-BREF scale [Post intervention: Three months after intervention]
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
- WHOQOL-BREF scale [Post intervention: Six months after intervention]
Evaluation of quality of life. There are no proposed cut-off points. The higher the score, the higher the quality of life.
Other Outcome Measures
- Change in resting state functional connectivity [Evaluation immediately post intervention]
functional near-infrared spectroscopy-fNIRS
- Change in resting state functional connectivity [Post intervention: One month after intervention]
functional near-infrared spectroscopy-fNIRS
- Change in resting state functional connectivity [Post intervention: Three months after intervention]
functional near-infrared spectroscopy-fNIRS
- Change in resting state functional connectivity [Post intervention: Six months after intervention]
functional near-infrared spectroscopy-fNIRS
- Motor evaluation [Evaluation immediately post intervention]
Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks
- Motor evaluation [Post intervention: One month after intervention]
Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks
- Motor evaluation [Post intervention: Three months after intervention]
Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks
- Motor evaluation [Post intervention: Six months after intervention]
Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks
- Blood biomarkers [Evaluation immediately post intervention]
Brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), nerve growth factor (NGF), pituitary adenylate cyclase polypeptide 38 (PACAP-38), insulin-like growth factor type 1 (IGF-1), interleukins 2, 4, 6, 8 and 10; and tumour necrosis factor (TNF).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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The stroke occurred during the 3 months prior to inclusion in the study.
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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.
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Patients with functional independence prior to the stroke, defined as a modified rankin scale score < 3 points.
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The patient gives informed consent.
Exclusion Criteria:
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Presence of other pathologies that may be a potential cause of disability or cognitive impairment.
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Moderate or severe aphasia that hinders communication.
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Severe sensory and/or motor impairments that prevent the completion of the evaluation and/or intervention processes.
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Presence of extensive vascular leukopathia (leukoaraiosis grade 3, 4).
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History of epilepsy or seizures.
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Presence of severe systemic pathology, including cardiac, hepatic or renal failure, active neoplasia.
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Failure to meet any of the inclusion criteria recorded in the Screening for electrical stimulation of the University of Göttingen.
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Presence of:
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Pacemaker.
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Electrical and/or metallic implants.
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Pregnancy.
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Anticonvulsant medication.
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Tattoos in the area of electrode placement.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Torrecardenas University Hospital | Almería | Almeria | Spain | 04009 |
Sponsors and Collaborators
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Instituto de Salud Carlos III
- Universidad de Almeria
Investigators
- Principal Investigator: Patricia Martinez Sanchez, PhD, Torrecardenas University Hospital
- Study Director: Pilar Flores Cubos, Professor, PhD, Department of Psychology. University of Almeria
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MODUL-EXE