Brain Correlates of Multimodal Rehabilitation in Chronic Post-stroke Aphasia

PHASE3CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 8, 2019

Primary Completion Date

October 20, 2020

Study Completion Date

October 20, 2020

Conditions
AphasiaStroke
Interventions
DRUG

Donepezil

Donepezil shall be administered at the times stipulated in the study design as follows: one 5 mg tablet at night for 4 weeks and then one 10 mg tablet at night until the end of the trial (week 10).

BEHAVIORAL

Intensive-Language Action Therapy

All patients participating in the study will receive in weeks 9 and 10 daily three and a half hours of ILATplus therapy. This therapy consists of 30 minutes of specific repetition training (tailored and reinforced by the therapist) before starting with classic ILAT for 3 hours/day during 10 consecutive days.

DEVICE

Transcranial direct current stimulation

Transcortical direct current stimulation (tDCS) will be applied using a STARSTIM neurostimulation device (Neuroelectrics, Barcelona). Each participant will receive either anodal or sham 20-minute sessions while receiving ILATplus. In the sham stimulation, the same helmet and electrode that is used in the active stimulation will be placed but, in this case, we will apply only a slight current at the beginning and end of the session with the objective of simulating the effects that are experienced with the active stimulation without producing significant cortical stimulation. The active electrode will be placed in the region of the lower right frontal rotation and the reference electrode in the extraencephalic zone (left clavicle). Combined rehabilitation sessions (ILATplus/tDCS) will be conducted, as indicated above, in weeks 9 and 10 of the trial.

Trial Locations (1)

29010

Centro de Investigaciones Medico-Sanitarias. University of Malaga, Málaga

All Listed Sponsors
lead

University of Malaga

OTHER

NCT04134416 - Brain Correlates of Multimodal Rehabilitation in Chronic Post-stroke Aphasia | Biotech Hunter | Biotech Hunter