Clinical trial NCT05329818: Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
Official title: Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Neuromodulation
Transcranial direct current stimulation
Non-invasive brain stimulation
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to investigate the therapeutic potential of a high definition transcranial direct current stimulation protocol, stimulating frontal and cerebellar areas boosting the cognitive and motor recovery of stroke population.

Detailed description: Stroke cause direct network dysfunctions correlating with the underlying behavioral deficits In that context, characterize and boost neuronal reshaping towards a favorable state for recovery has become a distinguished therapeutic approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation able to locally modulate neuronal activity and modify neural arquitecture.

In such scenario, the investigators develop in this protocol a new tDCS multitarget fronto-cerebellar tDCS approach, exploring the benefits of boosting motor dysfunctions by means of a dual site-approach, up-regulating dlPFC and CB activity. The investigators here design a pilot experimental clinical trial exploring the accumulative clinical potential for motor skill \& learning recovery and EEG effects of a high-density bifocal transcranial direct current stimulation protocol (HD-tDCS).

The investigators hypothesize that the tDCS protocol will promote direct functional motor reorganization helping relearning motor process, will boost the activity of prefrontal settled systems correcting attentional deficits and increasing strength connectivity with premotor systems, and will normalize large-scale abnormalities increasing interhemispheric functional connectivity (i.e., functional integration), decreasing interhemispheric asymmetry (i.e., functional segregation) and restoring transcallosal balance, impacting positively either in motor and cognitive recovery. All in all, this study will be the first exploring the simultaneous modulation of two different targets in stroke population corresponding to different networks looking for a summative/synergistic effects helping motor and cognitive functions recovery.

Eligibility criteria: Inclusion Criteria:

* Received a diagnosis of supratentorial ischemic or hemorrhagic stroke confirmed by neuroimage (MRI, PET, CT, fMRI or DTI) in the middle cerebral artery territory or encompassing fronto-temporo-parietal hemorrhages
* Enrolled in a live rehabilitation program in the rehabilitation and physical medicine department
* Between 4 and 12 months after stroke episode
* Have signed the informed form

Exclusion Criteria:

* Medical instability with the presence of infections, assisted ventilation, epilepsy or recurrent seizures, untreated psychiatric disorders or an active treatment with sedative drugs
* tDCS contraindications as defined by the international safety guidelines
* Large aphasic, psychiatric and cognitive deficits limiting patient's comprehension

Primary outcomes:
measure: Pre-to-post intervention change on motor skills. To measure such domain, the Fugl-Meyer assessment (FMA) will be used.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
Secondary outcomes:
measure: Pre-to-post intervention change on motor adaptation skills. To measure such domain, a computer-based visuo-motor task will be used.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
measure: Pre-to-post intervention change on cognitive abilities.To measure such domain. the AX-continuous performance task (AX-CPT) will be used.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
measure: Pre-to-post intervention change on cognitive abilities. To measure such domain the Montreal cognitive assessment (MoCA) will be used.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
measure: Pre-to-post intervention change on global stroke impairment. To measure such domain the National institutes of health stroke scale (NIHSS) will be used.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
measure: Pre-to-post intervention change on neglect impairment. To measure such domain, the letter cancelation test, the bell cancelation test and the line bisection test will be used.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
measure: Pre-to-post intervention modualtion of resting-state and task-engaged power spectral frequency, functional connectivity and entropy. To measure such domains, a electroencephalography (EEG) analysis will be conducted.
timeFrame: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
measure: Correlations between the electric field impact and the changes in the behavioral outcomes (clinical outcomes and eeg response). To perform such correlations, individual simulated biophysical models of electric stimulation distribution will be conducted.
timeFrame: MRI will be acquired 2 weeks before treatment onset or from the medical database.
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: University Hospital Joan XXIII
state: Cataluña
Study officials:
References: