- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277351
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
Role of Auditory Cortical Oscillations in Speech Processing and Its Dysfunction in Dyslexia Through Transcranial Alternating Current Stimulation
This study aims at investigating the role of low-gamma activity in phonemic encoding and its implication in dyslexia. Indeed, a phonological deficit, i.e. a difficulty in perceiving the sounds of speech, is strongly suspected in dyslexia but has never been conclusively associated with a specific underlying mechanism.
The study employs transcranial alternating current stimulation in adults with and without dyslexia to exploit the effect of the stimulation on phonemic processing and neural activity measured with electroencephalography. In doing so, it would be possible to establishing a causal link between gamma oscillations and the phonological deficit in dyslexia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Geneva, Switzerland, 1202
- Campus Biotech Geneva
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-65 years old;
- French native speakers;
- normally-hearing;
- intellectual quotient (IQ) around average;
- for the dyslexia group: previous diagnosis of dyslexia as assessed by a speech therapist.
Exclusion Criteria:
- Presence of metal or electronic implants in the brain/skull;
- Presence of metal or electronic device at other in other parts of the body;
- Have experienced a seizure or a loss of consciousness or a severe head trauma;
- Severe brain related illness ;
- Intake of central nervous system-effective medication;
- Pregnant and nursing women;
- Relatives affected by epilepsy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: tACS in individuals with and without dyslexia
Each participant in both the group of normo-readers and individuals with dyslexia receive all tACS stimulation conditions (fixed frequencies and sham) over different experimental days.
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Focal transcranial stimulation over auditory cortex by means of 5 electrodes delivering an electric current (max.
2mA).
In addition to active stimulation, also a placebo (sham) stimulation is employed as a control condition.
All subjects included in the study receive all tACS stimulation conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measure low-gamma neural oscillations with electroencephalography recordings
Time Frame: 6 hour
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Auditory-steady state responses to auditory stimuli are measured to assess specific differences between individuals with dyslexia and normo-readers, and between the different tACS stimulation conditions before, after and 1h after the 20 min. tACS stimulation. These neural correlated are estimated by considering the power of EEG signal at the frequency used to modulate the auditory stimuli. |
6 hour
|
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Changes in linguistic performance through a battery of behavioral tests
Time Frame: 6 hours
|
Measurement of phonemic and syllabic processing (pseudoword repetition and spoonerism test), and reading (reading a 3 min.
text, both accuracy and reading speed are considered) skills.
These tests are repeated before, after and 1h after the tACS stimulation.
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6 hours
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anne-Lise Giraud, Prof., University of Genova
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHONOSTIM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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