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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277351
Other study ID # PHONOSTIM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date September 1, 2018

Study information

Verified date February 2020
Source University of Geneva, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial alternating current stimulation
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.

Locations

Country Name City State
Switzerland Campus Biotech Geneva Geneva

Sponsors (2)

Lead Sponsor Collaborator
University of Geneva, Switzerland Wyss Center for Bio and Neuroengineering

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Lehongre K, Ramus F, Villiermet N, Schwartz D, Giraud AL. Altered low-? 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6 hour
Primary 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. 6 hours
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