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

Transcranial Direct Current Stimulation Clinical Trial

— MODUL-EXE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628818
• Other study ID #: MODUL-EXE
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2023
• Source: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
• Contact: Laura Amaya Pascasio, MD
• Phone: +34 950016860
• Email: laura.amaya.pascasio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transcranial Direct Current Stimulation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Torrecardenas University Hospital	Almería	Almeria

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental	Instituto de Salud Carlos III, Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in resting state functional connectivity	functional near-infrared spectroscopy-fNIRS	Evaluation immediately post intervention
Other	Change in resting state functional connectivity	functional near-infrared spectroscopy-fNIRS	Post intervention: One month after intervention
Other	Change in resting state functional connectivity	functional near-infrared spectroscopy-fNIRS	Post intervention: Three months after intervention
Other	Change in resting state functional connectivity	functional near-infrared spectroscopy-fNIRS	Post intervention: Six months after intervention
Other	Motor evaluation	Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks	Evaluation immediately post intervention
Other	Motor evaluation	Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks	Post intervention: One month after intervention
Other	Motor evaluation	Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks	Post intervention: Three months after intervention
Other	Motor evaluation	Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks	Post intervention: Six months after intervention
Other	Blood biomarkers	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).	Evaluation immediately post intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	modified rankin scale	Functional assessment scale ranging from 0 (independent) to 6 (death)	Evaluation immediately post intervention
Secondary	modified rankin scale	Functional assessment scale ranging from 0 (independent) to 6 (death)	Evaluation post intervention: One month after intervention
Secondary	modified rankin scale	Functional assessment scale ranging from 0 (independent) to 6 (death)	Post intervention: Three months after intervention
Secondary	modified rankin scale	Functional assessment scale ranging from 0 (independent) to 6 (death)	Post intervention: Six months after intervention
Secondary	modified rankin scale	Functional assessment scale ranging from 0 (independent) to 6 (death)	Post intervention: 12 months after intervention
Secondary	Return to work	To determine whether the patient has been able to return to the previous job	Post intervention: One month after intervention
Secondary	Return to work	To determine whether the patient has been able to return to the previous job	Post intervention: Three months after intervention
Secondary	Return to work	To determine whether the patient has been able to return to the previous job	Post intervention: 6 months after intervention
Secondary	Return to work	To determine whether the patient has been able to return to the previous job	Post intervention: 12 months after intervention
Secondary	Beck's Depression Inventory	Evaluation of depression ranging from 0 to 63. A score > 20: significant depression (moderate-severe)	Evaluation immediately post intervention
Secondary	Beck's Depression Inventory	Evaluation of depression ranging from 0 to 63. A score > 20: significant depression	Post intervention: One month after intervention
Secondary	Beck's Depression Inventory	Evaluation of depression ranging from 0 to 63. A score > 20: significant depression	Post intervention: Three months after intervention
Secondary	Beck's Depression Inventory	Evaluation of depression ranging from 0 to 63. A score > 20: significant depression	Post intervention: Six months after intervention
Secondary	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.	Evaluation immediately post intervention
Secondary	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.	Post intervention: One month after intervention
Secondary	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.	Post intervention: Three months after intervention
Secondary	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.	Post intervention: Six months after intervention
Secondary	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.	Evaluation immediately post intervention
Secondary	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.	Post intervention: One month after intervention
Secondary	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.	Post intervention: Three months after intervention
Secondary	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.	Post intervention: Six months after intervention