Aphasia Non FluentNCT06776978
Effectiveness of TDCS Over Broca's Area in Verb Naming: a Randomized, Double-Blind, Crossover Study
A study testing Active treatment in people with Aphasia Non Fluent and Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphasia Non Fluent, Stroke
- What is being tested?
- Active treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2023to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- native Italian proficiency;
- pre-morbid right-handedness;
- a single left hemispheric stroke at least 6 months before the investigation.
Who cannot join
- acute or chronic neurological symptoms requiring medication;
- attention and/or memory deficits.
Trial locations and contacts
1 site in 1 country.
About this 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
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:
Read more
- 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
- Being tested
- Active treatment, Sham Stimulation
- Keywords
- Transcranial Direct Current Stimulation, Aphasia, Verb Naming, Language Rehabilitation, Speech Therapy, Stroke
- Medical subject headings
- Aphasia, Broca, Stroke, Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active treatmentDevice
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 StimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants receive anodic tDCS over Broca's area at 2 mA for 20 minutes per session, 5 days per week for 2 consecutive weeks. Receives: Device: Active treatment |
| Sham tDCS | Sham comparator | Participants receive sham tDCS for 20 minutes per session, 5 days per week for 2 consecutive weeks. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Naming Task
An action naming task was designed to evaluate verb naming performance. Video clips depicting various actions were presented on a 15-inch computer screen at a viewing distance of 1 meter, each preceded by an 800-millisecond fixation point. Participants were instructed to name the action depicted in each clip within a 15-second response window. The examiner manually recorded correct responses. For incorrect responses or failures to respond within the allotted time, the written name of the action was displayed beneath the video, and participants were required to read the name aloud. The video and the written name remained on the screen until the word was read correctly or 40 seconds had elapsed. The task was conducted during 20-minute tDCS sessions, wherein participants received either active stimulation targeting Broca's area or sham stimulation with identical electrode placement but no active current.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start4 Dec 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aphasia Non FluentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Caltagirone, MD, PhD, Principal investigator, Fondazione Santa Lucia, Via Ardeatina 306, 00179 Roma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776978
- Sponsor's protocol ID
- CE/prog.733
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3003019Nishitani 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.
PubMed 15653841Marangolo 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.
PubMed 23142815
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06776978
- Acronym / sponsor ID
- CE/prog.733
- Conditions
- Aphasia Non Fluent, Stroke
- Keywords
- Transcranial Direct Current Stimulation, Aphasia, Verb Naming, Language Rehabilitation, Speech Therapy, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active treatmentParticipants receive anodic tDCS over Broca's area at 2 mA for 20 minutes per session, 5 days per week for 2 consecutive weeks. |
| Sham tDCS | Sham comparator | Device: Sham StimulationParticipants receive sham tDCS for 20 minutes per session, 5 days per week for 2 consecutive weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- native Italian proficiency;
- pre-morbid right-handedness;
- a single left hemispheric stroke at least 6 months before the investigation.
Key exclusion criteria (2 listed)
- acute or chronic neurological symptoms requiring medication;
- attention and/or memory deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active treatmentParticipants 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 | Active tDCS |
| Sham StimulationParticipants 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). | Device | Sham tDCS |
Primary outcome
Action Naming Task
Time frame: 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.
An action naming task was designed to evaluate verb naming performance. Video clips depicting various actions were presented on a 15-inch computer screen at a viewing distance of 1 meter, each preceded by an 800-millisecond fixation point. Participants were instructed to name the action depicted in each clip within a 15-second response window. The examiner manually recorded correct responses. For incorrect responses or failures to respond within the allotted time, the written name of the action was displayed beneath the video, and participants were required to read the name aloud. The video and the written name remained on the screen until the word was read correctly or 40 seconds had elapsed. The task was conducted during 20-minute tDCS sessions, wherein participants received either active stimulation targeting Broca's area or sham stimulation with identical electrode placement but no active current.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 3003019Syka 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.
- Background: PubMed 15653841Nishitani 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.
- Background: PubMed 23142815Marangolo 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.
- Individual participant dataSharing planned: No
Related trials for Aphasia Non Fluent
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
Active, not recruiting
Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia
Aphasia Non Fluent, Stroke
Recruiting
Targeting Language-specific and Executive-control Networks With Transcranial Direct Current Stimulation in Logopenic Variant PPA
Logopenic Progressive Aphasia, Primary Progressive Aphasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Caltagirone, MD, PhD principal investigator
Fondazione Santa Lucia, Via Ardeatina 306, 00179 Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active treatment in people with Aphasia Non Fluent and Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Naming Task (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776978, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.