Behavioral and Neural Characteristics of Adaptive Speech Motor Control

Speech Clinical Trial

Official title:

Behavioral and Neural Characteristics of Adaptive Speech Motor Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164717
• Other study ID #: STUDY00001367
• Secondary ID: R01DC020707R01DC
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: University of Washington
• Contact: Ludo Max
• Phone: 206-543-2674
• Email: ludomax[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 507
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Speech

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measurements will be made only from acoustic recordings made during the test session (~1 hour).
Primary	Reach direction for arm movements	Measuring initial reach direction for arm movements allows us to measure the direction that was planned before movement onset.	Outcome measures will be made only during a single data recording session (~2 hours).
Primary	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.	Measurements will be made only from electroencephalography (EEG) recordings made during the test session (~2 hours).
Primary	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.	Measurements will be made only from DBS implant recordings made during the test session (~1-2 hours).
Primary	Temporal measures of speech syllable sequence learning	1. Speech onset time (in milliseconds); 2. Average syllable duration (in milliseconds)	Outcome measures will be made only during a single data recording session (~0.5 hours)
Primary	Accuracy during speech syllable sequence learning	Sequence accuracy (in percent)	Outcome measures will be made only during a single data recording session (~0.5 hours)