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

NCT05570578 | Completed DMC

• 1 other identifier: 2022-D0058
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Aphasia

Keywords

tDCS; Functional connectivity; EEG

Outcome Measures

Primary Outcomes (1)

• Action picture naming, short-term improvement

  Change in number of correctly named action pictures

  Change from day 1 (baseline) to day 5 (posttest)

Secondary Outcomes (1)

• Functional connectivity between Broca's and Wernicke's area

  Change from day 1 (baseline) to day 5 (posttest)

Other Outcomes (3)

• Action picture naming, long-term improvement

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

• Narrative speech, short-term improvement

  Change from day 1 (baseline) to day 5 (posttest)

• Narrative speech, long-term improvement

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

Study Arms (2)

HD-tDCS

ACTIVE COMPARATOR

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

Device: HD-tDCS

sham-tDCS

SHAM COMPARATOR

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.

Device: HD-tDCS

Interventions

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.

Also known as: high-density transcranial direct current stimulation, DC-stimulator

HD-tDCS; sham-tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adrian Guggisberg: lead

Study Sites (1)

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian G Guggisberg, MD

  University of Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: sham-tDCS
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin conseil

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: October 24, 2022
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once the study has been published
• Access Criteria: Open Access

Locations

CH (1)