Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT06164717

Conditions

Speech

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Interventions

Auditory feedback perturbation during speech

Visual feedback perturbation during reaching

DBS stimulation ON/OFF

Study Details

Brief 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.

Conditions

Speech

Study ID

NCT06164717

Start date

Jan 1, 2023

Status verified date

Dec, 2023

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

507 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: Deep brain stimulation

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.

Interventions

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.

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 measure

  • Speech formant frequencies [ Time Frame: Measurements will be made only from acoustic recordings made during the test session (~1 hour). ]
  • Reach direction for arm movements [ Time Frame: 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 [ Time Frame: Measurements will be made only from electroencephalography (EEG) recordings made during the test session (~2 hours). ]
  • 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). ]
  • Temporal measures of speech syllable sequence learning [ Time Frame: Outcome measures will be made only during a single data recording session (~0.5 hours) ]
  • Accuracy during speech syllable sequence learning [ Time Frame: Outcome measures will be made only during a single data recording session (~0.5 hours) ]

Central Contacts and Locations

Central contacts

Ludo Max

206-543-2674ludomax@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Patrick Olsen

206-685-7792kolsen@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Dec 11, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2023-12-11.