SpeechNCT05286658
Behavioral and Neural Responses to External Alterations of Speech Variability
A study testing MEG/EEG, MRI and Speaking Tasks in people with Speech, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Speech
- What is being tested?
- MEG/EEG, MRI and Speaking Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2021to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking adults
- diagnosed communicative disorder, target populations may include:
- stroke survivors with aphasia
- individuals with cerebellar ataxia
- individuals with parkinson's disease
- individuals who use cochlear implants to hear
Show all 10Show fewer
- adults who stutter
- English-speaking adults
- normal hearing and speech
- no history of stroke or neurological conditions
Who cannot join
- Native language other than English
- Any neurological disorders other than the disorder of interest
- Any history of hearing disorders
- Uncorrected vision problems that prevent participants from seeing visually-presented stimuli
- Significant cognitive impairments that prevent participants from carrying out the task or from giving informed consent
- Vulnerable populations (minors and prisoners)
Show all 27Show fewer
- Additional exclusionary criteria if participating in neuroimaging:
- Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)
- Head too large for MEG recording helmet
- Claustrophobia or intolerance of MRI scanner noise
- Low signal to noise ratio in pilot MEG recordings
- High levels of artifacts (eye-blinks, etc.)
- Inability to produce the speech sounds proposed with minimal movement
- Left-handedness
- Additional exclusionary criteria if participating in transcranial magnetic stimulation (TMS):
- Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)
- Increased risk in the event of a seizure
- Serious heart disease
- Increased intracranial pressure
- Pregnancy
- History of seizures
- Family history of epilepsy
- Epileptogenic medications
- Chronic or transient disruption of sleep (including jet lag)
- History of fainting
- Chronic or transient increase in stressful experiences
- Use of illegal drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin
Madison, Wisconsin, 53705
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Behavioral and Neural Measures of Speech Motor Control
The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people who have communication disorders. 15 participants will be enrolled into this part of the study and can expect to be on study for 3-4 visits of 2-4 hours each.
Read the detailed description
The overall study (Establishing the clinical utility of sensorimotor adaptation for speech rehabilitation) aims to understand how cognitive, perceptual, and motor processes are integrated in the control of speech movements. The investigators study how this complex skill is performed in healthy speakers to understand how this system functions, how this skill relates to the perception of speech, and what role different parts of the brain play in this process. Different studies look at how speech motor control is executed, maintained, and changed. Overall, the study will recruit 329 participants over the course of 5 years. Participants can expect to be on study for up to 3 weeks.
The entire study is composed of 8 experiments and 6 interventions. The present record represents the experiments involving magnetoencephalographic (MEG) imaging, i.e. Experiment 5: Behavioral and neural responses to external alterations of speech variability.
This paradigm modulates the perceived speech variability of participants through three different altered auditory feedback sessions: an inward-pushing feedback perturbation that decreases perceived variability by playing back participants' speech closer to the center of their vowel distributions, an outward-pushing feedback perturbation that increases perceived variability by playing back participants' speech farther from the center of their vowel distributions, and a normal feedback condition in which speech feedback is played back without perturbation. Participants will complete this paradigm during MEG imaging, which will noninvasively measure auditory cortical activity evoked during speech production and playback.
- Conditions
- Speech
- Being tested
- MEG/EEG, MRI, Speaking Tasks
- Keywords
- speech motor control, vocal learning
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEG/EEGBehavioural
Also called magnetoencephalogram / electroencephalogram
The participant will sit still while their head is slid into the helmet-shaped bottom of the MEG device. The MEG contains sensors that passively detect weak magnetic fields outside the head produced by brain activity. The computer records the brain's electrical activity on the screen as wavy lines. The investigators will also ask you to wear sensors to capture eye-blinks (electrooculogram) and heartbeats (electrocardiogram) to facilitate removal from the MEG signal during analysis.
Participant will sit in front of a projector screen and be asked to put on a pair of headphones. Participant will be shown real words or nonsense words to read, the investigators may play sounds through headphones for the participant to repeat. Participant speech will be recorded by a microphone. The investigators may ask the participant to identify what they heard by pressing a button on a button-box. These tasks are expected to take about one hour to complete.
MRIBehavioural
Also called magnetic resonance imaging
An MRI is a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body. The participant will be able to hear and speak to the research staff at all times during the MRI procedures. The MRI test will take about 15 minutes.
Speaking TasksBehavioural
The participant may be asked to perform some of the tasks from MEG again, this time outside of the scanner. As before, the participant may see real words or nonsense words to read, and the investigators may play sounds through headphones and ask the participant to repeat them. Participant speech will be recorded by a microphone. The investigators may ask the participant to identify what they heard by pressing a button on a button-box. These tasks are expected to take about one hour to complete.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Speakers | Experimental | healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ Receives: Behavioral: MEG/EEG; Behavioral: MRI; Behavioral: Speaking Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speaking-Induced Suppression (SIS) Change, Defined as the Percent Change of SIS (the Z-score Difference in Average M100 Amplitude in the Speak Condition Compared With the Listen Condition) From Baseline to Test Phases
The dependent measure is the speaking-induced suppression (SIS) defined as the z-score difference in average M100 amplitude in the speak condition compared with the listen condition. The M100 peak is defined as the peak activity between 75 and 150 ms after stimulus onset; peaks will be confirmed by visual inspection. The percent change in this SIS from the pre-test (baseline phase at the beginning of the MEG scan) to the post-test (test phase at the end of the MEG scan) is evaluated for each of three visits: "in", "out", and "control".
Measured: Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start19 Oct 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpeechStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Carrie Niziolek, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286658
- Sponsor's protocol ID
- 2017-1128 MEG Imaging (Exp 5)
- Other IDs
- Protocol Version 8/25/2021, A481800, 1R01DC019134-01A1
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2022
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neural Measures of Speech Motor Control
- ClinicalTrials.gov ID
- NCT05286658
- Acronym / sponsor ID
- 2017-1128 MEG Imaging (Exp 5)
- Conditions
- Speech
- Keywords
- speech motor control, vocal learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people who have communication disorders. 15 participants will be enrolled into this part of the study and can expect to be on study for 3-4 visits of 2-4 hours each.
Detailed description
The overall study (Establishing the clinical utility of sensorimotor adaptation for speech rehabilitation) aims to understand how cognitive, perceptual, and motor processes are integrated in the control of speech movements. The investigators study how this complex skill is performed in healthy speakers to understand how this system functions, how this skill relates to the perception of speech, and what role different parts of the brain play in this process. Different studies look at how speech motor control is executed, maintained, and changed. Overall, the study will recruit 329 participants over the course of 5 years. Participants can expect to be on study for up to 3 weeks.
The entire study is composed of 8 experiments and 6 interventions. The present record represents the experiments involving magnetoencephalographic (MEG) imaging, i.e. Experiment 5: Behavioral and neural responses to external alterations of speech variability.
This paradigm modulates the perceived speech variability of participants through three different altered auditory feedback sessions: an inward-pushing feedback perturbation that decreases perceived variability by playing back participants' speech closer to the center of their vowel distributions, an outward-pushing feedback perturbation that increases perceived variability by playing back participants' speech farther from the center of their vowel distributions, and a normal feedback condition in which speech feedback is played back without perturbation. Participants will complete this paradigm during MEG imaging, which will noninvasively measure auditory cortical activity evoked during speech production and playback.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Speakers | Experimental | Behavioral: MEG/EEG, Behavioral: MRI, Behavioral: Speaking Taskshealthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- English-speaking adults
- diagnosed communicative disorder, target populations may include:
- English-speaking adults
- normal hearing and speech
- no history of stroke or neurological conditions
Key exclusion criteria (27 listed)
- Native language other than English
- Any neurological disorders other than the disorder of interest
- Any history of hearing disorders
- Uncorrected vision problems that prevent participants from seeing visually-presented stimuli
- Significant cognitive impairments that prevent participants from carrying out the task or from giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEG/EEGAlso: magnetoencephalogram / electroencephalogramThe participant will sit still while their head is slid into the helmet-shaped bottom of the MEG device. The MEG contains sensors that passively detect weak magnetic fields outside the head produced by brain activity. The computer records the brain's electrical activity on the screen as wavy lines. The investigators will also ask you to wear sensors to capture eye-blinks (electrooculogram) and heartbeats (electrocardiogram) to facilitate removal from the MEG signal during analysis. Participant will sit in front of a projector screen and be asked to put on a pair of headphones. Participant will be shown real words or nonsense words to read, the investigators may play sounds through headphones for the participant to repeat. Participant speech will be recorded by a microphone. The investigators may ask the participant to identify what they heard by pressing a button on a button-box. These tasks are expected to take about one hour to complete. | Behavioural | Healthy Adult Speakers |
| MRIAlso: magnetic resonance imagingAn MRI is a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body. The participant will be able to hear and speak to the research staff at all times during the MRI procedures. The MRI test will take about 15 minutes. | Behavioural | Healthy Adult Speakers |
| Speaking TasksThe participant may be asked to perform some of the tasks from MEG again, this time outside of the scanner. As before, the participant may see real words or nonsense words to read, and the investigators may play sounds through headphones and ask the participant to repeat them. Participant speech will be recorded by a microphone. The investigators may ask the participant to identify what they heard by pressing a button on a button-box. These tasks are expected to take about one hour to complete. | Behavioural | Healthy Adult Speakers |
Primary outcome
Speaking-Induced Suppression (SIS) Change, Defined as the Percent Change of SIS (the Z-score Difference in Average M100 Amplitude in the Speak Condition Compared With the Listen Condition) From Baseline to Test Phases
Time frame: Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session).
The dependent measure is the speaking-induced suppression (SIS) defined as the z-score difference in average M100 amplitude in the speak condition compared with the listen condition. The M100 peak is defined as the peak activity between 75 and 150 ms after stimulus onset; peaks will be confirmed by visual inspection. The percent change in this SIS from the pre-test (baseline phase at the beginning of the MEG scan) to the post-test (test phase at the end of the MEG scan) is evaluated for each of three visits: "in", "out", and "control".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to study record for experiment 7 \[NCT05723575\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Speech
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Niziolek, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEG/EEG, MRI and Speaking Tasks in people with Speech, run by University of Wisconsin, Madison at 2 sites in United States.
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 10 inclusion and 27 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: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speaking-Induced Suppression (SIS) Change, Defined as the Percent Change of SIS (the Z-score Difference in Average M100 Amplitude in the Speak Condition Compared With the Listen Condition) From Baseline to Test Phases (time frame: Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.