DyslexiaNCT04277351
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
A study testing Transcranial alternating current stimulation in people with Dyslexia, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- What is being tested?
- Transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2016to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dyslexia
- Being tested
- Transcranial alternating current stimulation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tACS in individuals with and without dyslexia | Experimental | 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. Receives: Device: Transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hour
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Wyss Center for Bio and Neuroengineering
- Responsible party
- Principal investigator, Anne-Lise Giraud, University of Geneva, Switzerland
- Investigators
- Anne-Lise Giraud, Prof., Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277351
- Sponsor's protocol ID
- PHONOSTIM
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22196341
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Auditory Cortical Oscillations in Speech Processing and Its Dysfunction in Dyslexia Through Transcranial Alternating Current Stimulation
- ClinicalTrials.gov ID
- NCT04277351
- Acronym / sponsor ID
- PHONOSTIM
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- Wyss Center for Bio and Neuroengineering
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tACS in individuals with and without dyslexia | Experimental | Device: Transcranial alternating current stimulationEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternating current stimulationFocal 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. | Device | tACS in individuals with and without dyslexia |
Primary outcome
Measure low-gamma neural oscillations with electroencephalography recordings
Time frame: 6 hour
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 22196341Lehongre 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.
Related trials for Dyslexia
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
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Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
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Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Lise Giraud, Prof. principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation in people with Dyslexia, run by University of Geneva, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure low-gamma neural oscillations with electroencephalography recordings (time frame: 6 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04277351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.