- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446350
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
Recruiting
Conditions
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
- Name: Mathieu MARX, PU-PH
- Phone Number: 33 +33 (0)5 61 77 77 04
- Email: marx.m@chu-toulouse.fr
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.
Sponsor
Collaborators
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
- 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.
- 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.
- 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.
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
Keywords
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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