Effectiveness of TDCS Over Broca's Area in Verb Naming: a Randomized, Double-Blind, Crossover Study

I.R.C.C.S. Fondazione Santa Lucia

Status: Completed

Conditions: Aphasia Non Fluent; Stroke

Treatments: Device: Active treatment; Device: Sham Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06776978

CE/prog.733

Details and patient eligibility

About

This clinical trial investigated whether transcranial direct current stimulation (tDCS) over Broca's area (F5) could improve verb naming abilities in adults with aphasia. Additionally, the study evaluated the stability of the treatment response to tDCS over time.

The main questions this study sought to answer were:

• Does tDCS improve verb naming abilities compared to inactive (sham) stimulation?
• Are the observed effects stable over time?

Participants received 10 daily sessions of tDCS over two consecutive weeks (5 days per week). The study included two treatment conditions, separated by one-month washout period:

• Active tDCS: Stimulation over Broca's area at 2 mA;
• Sham tDCS: Stimulation mimicking the active condition without delivering electrical current.

During the treatment, participants were asked to name aloud videos of actions displayed on a computer screen. One month after each treatment condition, follow-up testing was conducted to evaluate the stability of the treatment response.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• native Italian proficiency;
• pre-morbid right-handedness;
• a single left hemispheric stroke at least 6 months before the investigation.

Exclusion criteria

• acute or chronic neurological symptoms requiring medication;
• attention and/or memory deficits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

Active tDCS

Experimental group

Description:

Participants receive anodic tDCS over Broca's area at 2 mA for 20 minutes per session, 5 days per week for 2 consecutive weeks.

Treatment:

Device: Active treatment

Sham tDCS

Sham Comparator group

Description:

Participants receive sham tDCS for 20 minutes per session, 5 days per week for 2 consecutive weeks.

Treatment:

Device: Sham Stimulation