NCT05446350

Brief Summary

This study aims to further develop tACS as a tool to improve speech perception, by manipulation of brain-speech synchronisation ("entrainment"), thereby transforming a promising approach into a technique that can benefit to society on a large scale.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

July 1, 2022

Last Update Submit

August 18, 2022

Conditions

Keywords

Transcranial alternating current stimulation (tACS),speechperceptionneural oscillationsentrainmentphaseneurofeedback

Outcome Measures

Primary Outcomes (1)

  • correctly identified words

    percentage of correctly identified words during or after tACS who will permit to evaluate efficacy of tACS to modulate speech perception and neural responses in different experimental conditions (involving electrophysiological, brain imaging, and perceptual measures)

    Day 1

Secondary Outcomes (3)

  • correctly identified words with different modality

    day 1

  • oscillatory activities

    Day 1

  • neural activity

    Day 1

Study Arms (4)

Experiment 1

EXPERIMENTAL

The aim of Experiment 1 is to understand how tACS operates on the neural level

Procedure: transcranial alternating current stimulation (tACS)Procedure: electroencephalography (EEG)

Experiment 2

EXPERIMENTAL

The aim of Experiment 2 is to increase efficacy of tACS and, consequently, its potential to play an important role in research and everyday life applications

Procedure: transcranial alternating current stimulation (tACS)Procedure: brain imaging (fMRI)

Experiment 3

EXPERIMENTAL

The aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario.

Procedure: transcranial alternating current stimulation (tACS)

Experiment 4

EXPERIMENTAL

The aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception

Procedure: transcranial alternating current stimulation (tACS)Procedure: electroencephalography (EEG) with neurofeedback

Interventions

transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception

Experiment 1Experiment 2Experiment 3Experiment 4

analyse rhythmic electroencephalography responses that outlast the stimulation

Experiment 1

Using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants

Experiment 2

Using neurofeedback to teach participants to enhance their own neural entrainment

Experiment 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject aged between 18 and 50 years old
  • informed written consent
  • Absence of pro-epileptogenic drugs
  • Absence of visual or hearing impairment incompatible with participation in the study

You may not qualify if:

  • Pregnant or breastfeeding women,
  • Persons protected by law adults under guardianship or curatorship
  • Persons not affiliated to a Social Security scheme
  • Subjects with progressive psychiatric or neurological pathology
  • Subjects with a contraindication to tCS or MRI (history of epilepsy, severe head injury or brain/spinal cord surgery, cardiac pacemaker/defibrillator, implanted equipment activated by electrical, magnetic or mechanical system, hemostatic clip carriers of intracerebral aneurysms or carotid arteries, orthopedic implant carriers, claustrophobic, pregnancy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

RECRUITING

Related Publications (3)

  • van Bree S, Sohoglu E, Davis MH, Zoefel B. Sustained neural rhythms reveal endogenous oscillations supporting speech perception. PLoS Biol. 2021 Feb 26;19(2):e3001142. doi: 10.1371/journal.pbio.3001142. eCollection 2021 Feb.

    PMID: 33635855BACKGROUND
  • Zoefel B, Davis MH, Valente G, Riecke L. How to test for phasic modulation of neural and behavioural responses. Neuroimage. 2019 Nov 15;202:116175. doi: 10.1016/j.neuroimage.2019.116175. Epub 2019 Sep 6.

    PMID: 31499178BACKGROUND
  • Zoefel B, Allard I, Anil M, Davis MH. Perception of Rhythmic Speech Is Modulated by Focal Bilateral Transcranial Alternating Current Stimulation. J Cogn Neurosci. 2020 Feb;32(2):226-240. doi: 10.1162/jocn_a_01490. Epub 2019 Oct 29.

    PMID: 31659922BACKGROUND

MeSH Terms

Conditions

Speech

Interventions

Transcranial Direct Current StimulationNeuroimaging

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Mathieu MARX, PU-PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedikt ZOEFEL, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
masking to the conditions of the experiments
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations