Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
Primary Purpose
Dyslexia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transcranial alternating current stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Dyslexia
Eligibility Criteria
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.
Sites / Locations
- Campus Biotech Geneva
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tACS in individuals with and without dyslexia
Arm Description
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.
Outcomes
Primary Outcome Measures
Measure low-gamma neural oscillations with electroencephalography recordings
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.
Changes in linguistic performance through a battery of behavioral tests
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04277351
First Posted
February 13, 2020
Last Updated
February 17, 2020
Sponsor
University of Geneva, Switzerland
Collaborators
Wyss Center for Bio and Neuroengineering
1. Study Identification
Unique Protocol Identification Number
NCT04277351
Brief Title
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
Official Title
Role of Auditory Cortical Oscillations in Speech Processing and Its Dysfunction in Dyslexia Through Transcranial Alternating Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland
Collaborators
Wyss Center for Bio and Neuroengineering
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
One of three different tACS conditions is administered to all participant during three experimental days. The conditions differ in the frequency of stimulation (condition 1 and 2) and in whether the stimulation is active or faked (sham). The order of the three stimulation conditions is counterbalanced across participants, who are not aware of which tACS condition they are undergoing.
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tACS in individuals with and without dyslexia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure low-gamma neural oscillations with electroencephalography recordings
Description
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.
Time Frame
6 hour
Title
Changes in linguistic performance through a battery of behavioral tests
Description
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.
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Lise Giraud, Prof.
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Biotech Geneva
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22196341
Citation
Lehongre K, Ramus F, Villiermet N, Schwartz D, Giraud AL. Altered low-gamma sampling in auditory cortex accounts for the three main facets of dyslexia. Neuron. 2011 Dec 22;72(6):1080-90. doi: 10.1016/j.neuron.2011.11.002.
Results Reference
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Learn more about this trial
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
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