Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke (E-brain)

Xavier Corominas

Status: Unknown

Conditions: Stroke

Treatments: Device: high definition transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05329818

077/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Prefrontal stimulation.

Experimental group

Description:

Participants receive anodal tDCS on the ipsilesional dlPFC for 5days/week for 2 weeks.

Treatment:

Device: high definition transcranial direct current stimulation

Cerebellar stimulation.

Experimental group

Description:

Participants receive anodal tDCS on the contralesional cerebellum for 5days/week for 2 weeks. min of HD-tDCS with 2.0mA.

Treatment:

Device: high definition transcranial direct current stimulation

Fronto-cerebellar stimulation.

Experimental group

Description:

Participants receive simultaneous anodal tDCS on the ipsilesional dlPFC and in contralesional cerebellum for 5days/week for 2 weeks.

Treatment:

Device: high definition transcranial direct current stimulation

Sham stimulation.

Sham Comparator group

Description:

Participants receive sham tDCS for 5days/week for 2 weeks.

Treatment:

Device: high definition transcranial direct current stimulation