NCT06776978

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

La Stimolazione Transcranica (tDCS) E Transpinale a Corrente Diretta (tsDCS) Per Il Recupero Delle Funzioni Cognitive in Soggetti Affetti Da Patologia Cerebrovascolare O Neurodegenerativa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: I.R.C.C.S. Fondazione Santa Lucia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aphasia Non Fluent
• Stroke

Interventions

Type	Name	Description
DEVICE	Active treatment	Participants receive anodic tDCS using a battery-driven Eldith (neuroConn GmbH) Programmable Direct Current Stimulator with surface-soaked sponge electrodes (5×7 cm). A constant current of 2 mA is applied for 20 minutes per session. The stimulation targets the left frontal region (F5 of the extended International 10-20 EEG system), corresponding to Broca's area, while the reference electrode is placed over the contralateral frontopolar cortex. tDCS is performed for 10 daily sessions over two consecutive weeks (5 days per week).
DEVICE	Sham Stimulation	Participants receive sham tDCS using a battery-driven Eldith (neuroConn GmbH) Programmable Direct Current Stimulator with surface-soaked sponge electrodes (5×7 cm). No therapeutic current is applied during the 20-minute session. The electrode placement mimics the active condition, targeting the left frontal region (F5 of the extended International 10-20 EEG system), corresponding to Broca's area, while the reference electrode is placed over the contralateral frontopolar cortex. Sham tDCS is performed for 10 daily sessions over two consecutive weeks (5 days per week).

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: Italy