NCT04277351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 13, 2020

Last Update Submit

February 17, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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.

Device: Transcranial alternating current stimulation

Interventions

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.

tACS in individuals with and without dyslexia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Biotech Geneva

Geneva, 1202, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 22196341BACKGROUND

MeSH Terms

Conditions

Dyslexia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Anne-Lise Giraud, Prof.

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 20, 2020

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations