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HealthySPEECHSTIMNCT05446350

Modulating Speech Perception With Current Stimulation

A study testing transcranial alternating current stimulation (tACS), electroencephalography (EEG) and brain imaging (fMRI) in people with Healthy, run by University Hospital, Toulouse at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
transcranial alternating current stimulation (tACS), electroencephalography (EEG) and brain imaging (fMRI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteFrance
Study dates
1 Jul 2022to Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Mathieu MARX, PU-PH contact

+33 (0)5 61 77 77 04 ext. 33

marx.m@chu-toulouse.fr

Benedikt ZOEFEL, MD contact

France1 site, 1 recruiting

  • CHU Toulouse

    Toulouse, 31059

    Mathieu MARX, PU-PH, 05 61 77 77 04 ext. +33, marx.m@chu-toulouse.fr

    Mathieu MARX, PU-PH

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
transcranial alternating current stimulation (tACS), electroencephalography (EEG), brain imaging (fMRI), electroencephalography (EEG) with neurofeedback
Keywords
Transcranial alternating current stimulation (tACS),, speech, perception, neural oscillations, entrainment, phase, neurofeedback
Medical subject headings
Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial alternating current stimulation (tACS)Procedure or surgery

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

  • electroencephalography (EEG)Procedure or surgery

    analyse rhythmic electroencephalography responses that outlast the stimulation

  • brain imaging (fMRI)Procedure or surgery

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

  • electroencephalography (EEG) with neurofeedbackProcedure or surgery

    Using neurofeedback to teach participants to enhance their own neural entrainment

Study groups in NCT05446350
Study groupRoleWhat they receive
Experiment 1ExperimentalThe aim of Experiment 1 is to understand how tACS operates on the neural level
Receives: Procedure: transcranial alternating current stimulation (tACS); Procedure: electroencephalography (EEG)
Experiment 2ExperimentalThe 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
Receives: Procedure: transcranial alternating current stimulation (tACS); Procedure: brain imaging (fMRI)
Experiment 3ExperimentalThe aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario.
Receives: Procedure: transcranial alternating current stimulation (tACS)
Experiment 4ExperimentalThe aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception
Receives: Procedure: transcranial alternating current stimulation (tACS); Procedure: electroencephalography (EEG) with neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Day 1

Secondary outcomes (3)

  1. correctly identified words with different modality

    percentage of correctly identified words during or after tACS between different modality

    Measured: day 1

  2. oscillatory activities

    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

    Measured: Day 1

  3. neural activity

    measurement of neural activity that results from electrical stimulation: fMRI (BOLD response) during or after tACS

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start1 Jul 2022
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05446350
Sponsor's protocol ID
RC31/20/0340
Other IDs
2020-A02707-32, STIMPAROLE
Acronym
SPEECHSTIM
Status last verified
Aug 2022
First submitted
1 Jul 2022
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33635855

  • 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.

    PubMed 31499178

  • 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.

    PubMed 31659922

Questions about this trial

What is this clinical trial studying?

A study testing transcranial alternating current stimulation (tACS), electroencephalography (EEG) and brain imaging (fMRI) in people with Healthy, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mathieu MARX, PU-PH (+33 (0)5 61 77 77 04 ext. 33, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correctly identified words (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05446350, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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Modulating Speech Perception With Current Stimulation | AzTrials