Transcranial Direct Current Stimulation
Conditions
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.
Interventions
DEVICETranscranial 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.
DEVICESham 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.
Sponsors
Instituto de Salud Carlos III
Universidad de Almeria
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| modified rankin scale | Evaluation immediately post 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 |
| Beck's Depression Inventory | Evaluation immediately post intervention | Evaluation of depression ranging from 0 to 63. A score \> 20: significant depression (moderate-severe) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in resting state functional connectivity | Evaluation immediately post intervention | functional near-infrared spectroscopy-fNIRS |
| 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). |
| Motor evaluation | Evaluation immediately post intervention | Nine-hole peg test and Timed 25-Foot Walk tests as motor status monitoring tasks |
Countries
Spain
Contacts
Primary ContactLaura Amaya Pascasio, MD
Outcome results
None listed