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

NCT06776978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-01-15

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Carlo Caltagirone, MD, PhD · Fondazione Santa Lucia, Via Ardeatina 306, 00179 Roma, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-12-13
Completion
2024-12-13

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06776978 on ClinicalTrials.gov