Clinical trial NCT06776978: Effectiveness of TDCS Over Broca's Area in Verb Naming: a Randomized, Double-Blind, Crossover Study
Official title: La Stimolazione Transcranica (tDCS) E Transpinale a Corrente Diretta (tsDCS) Per Il Recupero Delle Funzioni Cognitive in Soggetti Affetti Da Patologia Cerebrovascolare O Neurodegenerativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia Non Fluent
Stroke
Keywords: Transcranial Direct Current Stimulation
Aphasia
Verb Naming
Language Rehabilitation
Speech Therapy
Stroke
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Action Naming Task
timeFrame: Verb naming performance was assessed at baseline (pre-treatment), post-treatment (immediately after the 10-day intervention), and at follow-up (one month after each treatment condition) to evaluate both immediate effects and the stability of responses.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: I.R.C.C.S. Fondazione Santa Lucia
Study officials:
affiliation: Fondazione Santa Lucia, Via Ardeatina 306, 00179 Roma, Italy
name: Carlo Caltagirone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.