Effectiveness of TDCS Over Broca's Area in Verb Naming: a Randomized, Double-Blind, Crossover Study
NCT ID: NCT06776978
Last Updated: 2025-01-15
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2023-12-04
2024-12-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Active tDCS
Participants receive anodic tDCS over Broca's area at 2 mA for 20 minutes per session, 5 days per week for 2 consecutive weeks.
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).
Sham tDCS
Participants receive sham tDCS for 20 minutes per session, 5 days per week for 2 consecutive weeks.
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
* pre-morbid right-handedness;
* a single left hemispheric stroke at least 6 months before the investigation.
Exclusion Criteria
* attention and/or memory deficits.
ALL
No
Sponsors
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I.R.C.C.S. Fondazione Santa Lucia
OTHER
Responsible Party
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Principal Investigators
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Carlo Caltagirone, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Santa Lucia, Via Ardeatina 306, 00179 Roma, Italy
Locations
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I.R.C.C.S. Fondazione Santa Lucia
Roma, Italy, Italy
Countries
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References
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Syka J, Melichar I. The effect of loop diuretics upon summating potentials in the guinea pig. Hear Res. 1985;20(3):267-73. doi: 10.1016/0378-5955(85)90031-0.
Nishitani N, Schurmann M, Amunts K, Hari R. Broca's region: from action to language. Physiology (Bethesda). 2005 Feb;20:60-9. doi: 10.1152/physiol.00043.2004.
Marangolo P, Fiori V, Di Paola M, Cipollari S, Razzano C, Oliveri M, Caltagirone C. Differential involvement of the left frontal and temporal regions in verb naming: a tDCS treatment study. Restor Neurol Neurosci. 2013;31(1):63-72. doi: 10.3233/RNN-120268.
Other Identifiers
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CE/prog.733
Identifier Type: -
Identifier Source: org_study_id
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