SpeechNCT06164717
Behavioral and Neural Characteristics of Adaptive Speech Motor Control
A study testing Auditory feedback perturbation during speech, Visual feedback perturbation during reaching and DBS stimulation ON/OFF in people with Speech, run by University of Washington at 1 site in United States.
Trial summary
This study meets the NIH definition of a clinical trial, but is not a treatment study. Instead, the goal of this study is to investigate how hearing ourselves speak affects the planning and execution of speech movements. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Speech
- What is being tested?
- Auditory feedback perturbation during speech, Visual feedback perturbation during reaching and DBS stimulation ON/OFF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
General inclusion criteria:
- native speaker of American English
- no communication or neurological problems (except for subjects in the DBS group)
- 250-4000 Hz pure tone hearing thresholds equal to or better than 25 dB HL for children and young adults and equal to or better than 35 dB HL for older adults
- no medications that affect sensorimotor functioning (except for in the DBS group)
- adult subjects: 18 years of age or older
- typical children: 4;0 to 6;11 [years;months] or 10;0 to 12;11 [years;months])
Specific inclusion criteria for children:
- scoring above the 20th percentile on the Peabody Picture Vocabulary Test (PPVT-5), Expressive Vocabulary Test (EVT-3), Goldman-Fristoe Test of Articulation (GFTA-3), and either Test of Early Language Development (TELD-4) or (for children age 8 or older) Clinical Evaluation of Language Fundamentals (CELF-5).
Specific inclusion criteria for DBS patients:
- bilateral electrodes implanted in either the ventral intermediate nucleus of the thalamus (Vim; a target site for patients with essential tremor) or subthalamic nucleus (STN; a target site for patients with Parkinson's disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98105
Patrick Olsen, 206-685-7792, kolsen@uw.edu
About this study
This study meets the NIH definition of a clinical trial, but is not a treatment study. Instead, the goal of this study is to investigate how hearing ourselves speak affects the planning and execution of speech movements. The study investigates this topic in both typical speakers and in patients with Deep Brain Stimulation (DBS) implants. The main questions it aims to answer are:
- Does the way we hear our own speech while talking affect future speech movements?
- Can the speech of DBS patients reveal which brain areas are involved in adjusting speech movements? Participants will read words, sentences, or series of random syllables from a computer monitor while their speech is being recorded. For some participants, an electrode cap is also used to record brain activity during these tasks. And for DBS patients, the tasks will be performed with the stimulator ON and with the stimulator OFF.
- Conditions
- Speech
- Being tested
- Auditory feedback perturbation during speech, Visual feedback perturbation during reaching, DBS stimulation ON/OFF
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory feedback perturbation during speechBehavioural
The intervention consists of manipulating real-time auditory feedback during speech production. In our lab, such feedback perturbations can be implemented with either a stand-alone digital vocal processor (a device commonly used by singers and the music industry) or with software-based signal processing routines (see Equipment section for details). Note that the study does not investigate the efficacy of these hardware or software methods to induce behavioral change in subjects' speech. Rather, the study addresses basic experimental questions regarding the general role of auditory feedback in the central nervous system's control of articulatory speech movements.
Visual feedback perturbation during reachingBehavioural
The intervention consists of manipulating real-time visual feedback during upper limb reaching movements. In our lab, such feedback perturbations can be implemented with a virtual reality display system.
DBS stimulation ON/OFFOther
Patients who have been previously implanted with a DBS stimulator for their clinical care will be tested in two speech motor learning tasks with the stimulation ON and with the stimulation OFF.
Note that (1) patients routinely turn the stimulation OFF and back ON (examples are, for some patients, to sleep, to save battery, etc), and (2) we are not in any way evaluating the stimulator itself or its clinical effectiveness but only whether or not two forms of speech motor learning (adaptation to auditory feedback perturbation and speech sequence learning) are affected differently by having the stimulation ON or OFF.
implant ON/OFF prior to participation in the speech auditory-motor learning tasks and speech sequence learning tasks. This intervention can be implemented by the subject themselves as all patients have a hand- held controlled that they use to switch stimulation ON/OFF.
| Study group | Role | What they receive |
|---|---|---|
| Auditory feedback perturbation during speech | Experimental | The intervention consists of manipulating real-time auditory feedback during speech production. In our lab, such feedback perturbations can be implemented with either a stand-alone digital vocal processor (a device commonly used by singers and the music industry) or with software-based signal processing routines (see Equipment section for details). Note that the study does not investigate the efficacy of these hardware or software methods to induce behavioral change in subjects' speech. Rather, the study addresses basic experimental questions regarding the general role of auditory feedback in the central nervous system's control of articulatory speech movements. Receives: Behavioral: Auditory feedback perturbation during speech |
| Visual feedback perturbation during reaching | Experimental | The intervention consists of manipulating real-time visual feedback during upper limb reaching movements. In our lab, such feedback perturbations can be implemented with a virtual reality display system. Receives: Behavioral: Visual feedback perturbation during reaching |
| Deep brain stimulation | Experimental | This intervention consists of toggling the deep brain stimulation (DBS) implant ON/OFF prior to participation in the speech auditory-motor learning tasks and speech sequence learning tasks. This intervention can be implemented by the subject themselves as all patients have a hand- held controlled that they use to switch stimulation ON/OFF. Receives: Other: DBS stimulation ON/OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech formant frequencies
The frequencies of the subject's first two formants (F1, F2) for each test word will be measured from spectrographic displays with overlaid Linear Predictive Coding formant tracks.
Measured: Measurements will be made only from acoustic recordings made during the test session (~1 hour).
Reach direction for arm movements
Measuring initial reach direction for arm movements allows us to measure the direction that was planned before movement onset.
Measured: Outcome measures will be made only during a single data recording session (~2 hours).
Amplitude of long-latency auditory evoked potentials (from EEG recordings) responses
Amplitude of the N1 component (in microvolt) will be measured in response to both probe tones and to a subject's own speech onset.
Measured: Measurements will be made only from electroencephalography (EEG) recordings made during the test session (~2 hours).
Local field potentials recorded by neural implants
Local field potentials (LFPs) will be recorded by the PerceptPC DBS implants and used to measure changes in power spectrum density across different phases of the tasks. Additionally, LFPs will be used to conduct event-related analyses.
Measured: Measurements will be made only from DBS implant recordings made during the test session (~1-2 hours).
Temporal measures of speech syllable sequence learning
- Speech onset time (in milliseconds); 2. Average syllable duration (in milliseconds)
Measured: Outcome measures will be made only during a single data recording session (~0.5 hours)
Accuracy during speech syllable sequence learning
Sequence accuracy (in percent)
Measured: Outcome measures will be made only during a single data recording session (~0.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 507 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Ludo Max, University of Washington
- Investigators
- Ludo Max, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164717
- Sponsor's protocol ID
- STUDY00001367
- Other IDs
- R01DC020707, R01DC014510
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neural Characteristics of Adaptive Speech Motor Control
- ClinicalTrials.gov ID
- NCT06164717
- Acronym / sponsor ID
- STUDY00001367
- Conditions
- Speech
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 507 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study meets the NIH definition of a clinical trial, but is not a treatment study. Instead, the goal of this study is to investigate how hearing ourselves speak affects the planning and execution of speech movements. The study investigates this topic in both typical speakers and in patients with Deep Brain Stimulation (DBS) implants. The main questions it aims to answer are:
- Does the way we hear our own speech while talking affect future speech movements?
- Can the speech of DBS patients reveal which brain areas are involved in adjusting speech movements? Participants will read words, sentences, or series of random syllables from a computer monitor while their speech is being recorded. For some participants, an electrode cap is also used to record brain activity during these tasks. And for DBS patients, the tasks will be performed with the stimulator ON and with the stimulator OFF.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auditory feedback perturbation during speech | Experimental | Behavioral: Auditory feedback perturbation during speechThe intervention consists of manipulating real-time auditory feedback during speech production. In our lab, such feedback perturbations can be implemented with either a stand-alone digital vocal processor (a device commonly used by singers and the music industry) or with software-based signal processing routines (see Equipment section for details). Note that the study does not investigate the efficacy of these hardware or software methods to induce behavioral change in subjects' speech. Rather, the study addresses basic experimental questions regarding the general role of auditory feedback in the central nervous system's control of articulatory speech movements. |
| Visual feedback perturbation during reaching | Experimental | Behavioral: Visual feedback perturbation during reachingThe intervention consists of manipulating real-time visual feedback during upper limb reaching movements. In our lab, such feedback perturbations can be implemented with a virtual reality display system. |
| Deep brain stimulation | Experimental | Other: DBS stimulation ON/OFFThis intervention consists of toggling the deep brain stimulation (DBS) implant ON/OFF prior to participation in the speech auditory-motor learning tasks and speech sequence learning tasks. This intervention can be implemented by the subject themselves as all patients have a hand- held controlled that they use to switch stimulation ON/OFF. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Auditory feedback perturbation during speechThe intervention consists of manipulating real-time auditory feedback during speech production. In our lab, such feedback perturbations can be implemented with either a stand-alone digital vocal processor (a device commonly used by singers and the music industry) or with software-based signal processing routines (see Equipment section for details). Note that the study does not investigate the efficacy of these hardware or software methods to induce behavioral change in subjects' speech. Rather, the study addresses basic experimental questions regarding the general role of auditory feedback in the central nervous system's control of articulatory speech movements. | Behavioural | Auditory feedback perturbation during speech |
| Visual feedback perturbation during reachingThe intervention consists of manipulating real-time visual feedback during upper limb reaching movements. In our lab, such feedback perturbations can be implemented with a virtual reality display system. | Behavioural | Visual feedback perturbation during reaching |
| DBS stimulation ON/OFFPatients who have been previously implanted with a DBS stimulator for their clinical care will be tested in two speech motor learning tasks with the stimulation ON and with the stimulation OFF. Note that (1) patients routinely turn the stimulation OFF and back ON (examples are, for some patients, to sleep, to save battery, etc), and (2) we are not in any way evaluating the stimulator itself or its clinical effectiveness but only whether or not two forms of speech motor learning (adaptation to auditory feedback perturbation and speech sequence learning) are affected differently by having the stimulation ON or OFF. implant ON/OFF prior to participation in the speech auditory-motor learning tasks and speech sequence learning tasks. This intervention can be implemented by the subject themselves as all patients have a hand- held controlled that they use to switch stimulation ON/OFF. | Other | Deep brain stimulation |
Primary outcome
Speech formant frequencies
Time frame: Measurements will be made only from acoustic recordings made during the test session (~1 hour).
The frequencies of the subject's first two formants (F1, F2) for each test word will be measured from spectrographic displays with overlaid Linear Predictive Coding formant tracks.
Reach direction for arm movements
Time frame: Outcome measures will be made only during a single data recording session (~2 hours).
Measuring initial reach direction for arm movements allows us to measure the direction that was planned before movement onset.
Amplitude of long-latency auditory evoked potentials (from EEG recordings) responses
Time frame: Measurements will be made only from electroencephalography (EEG) recordings made during the test session (~2 hours).
Amplitude of the N1 component (in microvolt) will be measured in response to both probe tones and to a subject's own speech onset.
Local field potentials recorded by neural implants
Time frame: Measurements will be made only from DBS implant recordings made during the test session (~1-2 hours).
Local field potentials (LFPs) will be recorded by the PerceptPC DBS implants and used to measure changes in power spectrum density across different phases of the tasks. Additionally, LFPs will be used to conduct event-related analyses.
Temporal measures of speech syllable sequence learning
Time frame: Outcome measures will be made only during a single data recording session (~0.5 hours)
1. Speech onset time (in milliseconds); 2. Average syllable duration (in milliseconds)
Accuracy during speech syllable sequence learning
Time frame: Outcome measures will be made only during a single data recording session (~0.5 hours)
Sequence accuracy (in percent)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
Ludo Max, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory feedback perturbation during speech, Visual feedback perturbation during reaching and DBS stimulation ON/OFF in people with Speech, run by University of Washington at 1 site 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?
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: looking for participants now, as of the sponsor's last update on 11 Dec 2023. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludo Max (206-543-2674, ludomax@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech formant frequencies (time frame: Measurements will be made only from acoustic recordings made during the test session (~1 hour).). The study lists 6 primary outcomes in all. 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 11 Dec 2023.