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

NCT ID: NCT05570578

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-24

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Aphasia

Keywords

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tDCS Functional connectivity EEG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
sham-tDCS

Study Groups

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HD-tDCS

high-density transcranial direct current stimulation (HD-tDCS) over Broca's area

Group Type ACTIVE_COMPARATOR

HD-tDCS

Intervention Type 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.

sham-tDCS

sham transcranial direct current stimulation. The same setup will be used as in the HD-tDCS arm, except that the current will be ramped up for 30 seconds and then switched off. This does not lead to neural effects, but the patients have a similar sensation.

Group Type SHAM_COMPARATOR

HD-tDCS

Intervention Type 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.

Interventions

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HD-tDCS

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.

Intervention Type DEVICE

Other Intervention Names

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high-density transcranial direct current stimulation DC-stimulator

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adrian Guggisberg

OTHER

Sponsor Role lead

Responsible Party

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Adrian Guggisberg

Médecin conseil

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adrian G Guggisberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

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Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Adrian G Guggisberg, MD

Role: CONTACT

Phone: +41316323081

Email: [email protected]

Facility Contacts

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Adrian G Guggisberg, MD

Role: primary

Other Identifiers

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2022-D0058

Identifier Type: -

Identifier Source: org_study_id