Modulating Speech Perception With Current Stimulation (SPEECHSTIM)

August 18, 2022 updated by: University Hospital, Toulouse

Modulating Speech Perception With Current Stimulation (SPEECHSTIM)

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.

Study Overview

Detailed Description

Neural oscillations align their phase to the rhythm of speech. This phenomenon is termed neural entrainment and associated with successful speech comprehension. Importantly, we have demonstrated that transcranial alternating current stimulation (tACS) can be used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception. The aim of Experiment 1 is to understand how tACS operates on the neural level. This aim will be reached by testing whether tACS produces rhythmic electroencephalography (EEG) responses that outlast the stimulation, indicating an involvement of endogenous oscillatory activity. 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. This aim will be reached by using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants. The aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario. This aim will be reached by using tACS to enhance attended speech or suppress distracting speech, and by comparing these two approaches in their efficacy to boost speech perception. The aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception. This aim will be reached by using neurofeedback to teach participants to enhance their own neural entrainment, applying tACS to support them in this process.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Benedikt ZOEFEL, MD

Study Locations

      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experiment 1
The aim of Experiment 1 is to understand how tACS operates on the neural level
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
analyse rhythmic electroencephalography responses that outlast the stimulation
EXPERIMENTAL: Experiment 2
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
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
Using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants
EXPERIMENTAL: Experiment 3
The aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario.
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
EXPERIMENTAL: Experiment 4
The aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
Using neurofeedback to teach participants to enhance their own neural entrainment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correctly identified words
Time Frame: Day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
correctly identified words with different modality
Time Frame: day 1
percentage of correctly identified words during or after tACS between different modality
day 1
oscillatory activities
Time Frame: Day 1
measurement of oscillatory activities resulting from electrical stimulation: (frequency, power, and phase, latency) on the scalp and at the level of the sources and their synchronization with during or after tACS
Day 1
neural activity
Time Frame: Day 1
measurement of neural activity that results from electrical stimulation: fMRI (BOLD response) during or after tACS
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2025

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (ACTUAL)

July 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RC31/20/0340
  • 2020-A02707-32 (OTHER: Id-RCB)
  • STIMPAROLE (OTHER: Acronyme)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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