- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05570578
Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming in Aphasic Patients.
Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Canton of Geneva
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Geneva, Canton of Geneva, Switzerland, 1211
- Division of Neurorehabilitation, University Hospital of Geneva
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: HD-tDCS
high-density transcranial direct current stimulation (HD-tDCS) over Broca's area
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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:
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Sham Comparator: 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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action picture naming, short-term improvement
Time Frame: Change from day 1 (baseline) to day 5 (posttest)
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Change in number of correctly named action pictures
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Change from day 1 (baseline) to day 5 (posttest)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Change from day 1 (baseline) to day 5 (posttest)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action picture naming, long-term improvement
Time Frame: Change from day 1 (baseline) to week 4 (follow-up)
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Change in number of correctly named action pictures
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Change from day 1 (baseline) to week 4 (follow-up)
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Narrative speech, short-term improvement
Time Frame: Change from day 1 (baseline) to day 5 (posttest)
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Patient describes cookie-theft picture and action-picture, change in score
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Change from day 1 (baseline) to day 5 (posttest)
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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
|
Change from day 1 (baseline) to week 4 (follow-up)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adrian G Guggisberg, MD, University of Geneva, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Aphasia
Other Study ID Numbers
- 2022-D0058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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