NCT06164717 · University of Washington
Behavioral and Neural Characteristics of Adaptive Speech Motor Control
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Auditory feedback perturbation during speech
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.
BEHAVIORAL
Visual feedback perturbation during reaching
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.
OTHER
DBS stimulation ON/OFF
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.
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Seattle, Washington
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 11, 2023 · Source of record for eligibility and locations