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Completed

NCT Number: NCT05570578

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming in Aphasic Patients.

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) allows to induce, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of a given cerebral region and to obtain a very focused cortical effect. Previous studies using HD-tDCS have shown the effectiveness of this stimulation technique for enhancing language recovery in patients with aphasia.

However, language processes are not determined solely by local neural activity at a single site, but rather by the interaction between neural networks. This is because a large cortical network is involved in language processes and, therefore, the same language disorder may result from lesions at different locations in this network.

The investigators hypothesize that anodal HD-tDCS will enhance neural interactions between language areas and, thereby, improve language processing and word learning.

The investigators propose to carry out a study on chronic aphasic patients involving HD-tDCS of the Broca region (left inferior frontal gyrus) combined with a verb learning task.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

About this study

Functional connectivity (FC) represents a means of analyzing functional interactions in the brain network by assessing the statistical dependence of neural activity between brain areas. The brain maintains a high level of interactions between brain areas even in the resting state, when it is not explicitly involved in a specific task. Resting-state interactions occur mainly in the so-called alpha frequency band (8-13 Hz) . Moreover, these resting-state interactions are crucial for correct task performance and learning. Indeed, healthy subjects with high resting-state alpha-band FC levels are better able to perform tasks and learn. For example, subjects with high levels of FC between Broca's area and the rest of the brain perform better on language production tasks and show greater training gains when learning new words. In addition, patients with brain damage due to stroke show a reduction in resting-state alpha-band FC, which correlates with the severity of neurological deficits. In particular, a loss of FC of structurally preserved inferior frontal areas was associated with more severe aphasia. Conversely, high-levels of FC between the inferior frontal brain areas and the rest of the brain during the first weeks after stroke was associated with better recovery from aphasia, probably reflecting a reorganization of neural connections as a neural mechanism involved in plasticity. Resting-state FC is therefore an interesting neural target for therapy, which could help improve recovery from aphasia.

In a previous study on healthy subjects, the investigators have indeed observed that HD-tDCS applied to Broca's area improves the ability for new-verb learning, i.e., the correct naming of action pictures. This improvement in learning correlated with greater increase in FC between Broca's and Wernicke's area.

The investigators now carry out a study on chronic aphasic patients involving HD-tDCS of the Broca region (left inferior frontal gyrus) combined with a verb learning task.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic or hemorrhagic stroke
  • Presence of aphasia with difficulty finding words and/or naming objects/pictures
  • ≥12 months post-stroke
  • ≥ 18 years of age
  • French-speaking
  • Able to participate in 30-60 min therapeutic sessions (good concentration and understanding of the task and ability to follow instructions

Exclusion criteria

  • Patients unable to understand the given information on the study and its objectives, or instructions for tasks performed.
  • Impaired alertness or delirium
  • Severe co-morbidity affecting speech
  • Contraindication to tDCS: pregnant women, patients with active implants such as pacemakers or cochlear implants, patients with one or more seizures, metal objects in the brain
  • Occurrence of a new stroke during the study protocol.

Treatment and study plan

HD-tDCS

Device

The anode electrode will be placed over Broca's area, 4 cathode electrodes will be placed at about 2 cm distance each from the anode in 4 directions.

Other names: high-density transcranial direct current stimulation, DC-stimulator

Primary outcomes

  1. Action picture naming, short-term improvement

    Time frame: Change from day 1 (baseline) to day 5 (posttest)

    Change in number of correctly named action pictures

Secondary outcomes

  1. Functional connectivity between Broca's and Wernicke's area

    Time frame: Change from day 1 (baseline) to day 5 (posttest)

    Change in the normalized imaginary component of coherence between Broca and Wernicke

Other outcomes

  1. Action picture naming, long-term improvement

    Time frame: Change from day 1 (baseline) to week 4 (follow-up)

    Change in number of correctly named action pictures

  2. Narrative speech, short-term improvement

    Time frame: Change from day 1 (baseline) to day 5 (posttest)

    Patient describes cookie-theft picture and action-picture, change in score

  3. Narrative speech, long-term improvement

    Time frame: Change from day 1 (baseline) to week 4 (follow-up)

    Patient describes cookie-theft picture and action-picture, change in score

Sponsors and collaborators

Lead sponsor

Adrian Guggisberg

Other

Registry information

Official study title

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2022
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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