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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Benedikt ZOEFEL, MD

Study Locations

  • France
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experiment 1
The aim of Experiment 1 is to understand how tACS operates on the neural level
Procedure: transcranial alternating current stimulation (tACS)
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
Procedure: electroencephalography (EEG)
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
Procedure: transcranial alternating current stimulation (tACS)
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
Procedure: brain imaging (fMRI)
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.
Procedure: transcranial alternating current stimulation (tACS)
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
Procedure: transcranial alternating current stimulation (tACS)
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
Procedure: electroencephalography (EEG) with neurofeedback
Using neurofeedback to teach participants to enhance their own neural entrainment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre National de la Recherche Scientifique, France

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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