Behavioral and Neural Responses to External Alterations of Speech Variability

Speech Clinical Trial

Official title:

Behavioral and Neural Measures of Speech Motor Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286658
• Other study ID #: 2017-1128 MEG Imaging (Exp 5)
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Patients):

• 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
• adults who stutter

Inclusion Criteria (Control):

• English-speaking adults
• normal hearing and speech
• no history of stroke or neurological conditions

Exclusion Criteria:

• 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)
• 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

Related Conditions & MeSH terms

• Speech

Intervention

Behavioral:
• MEG/EEG
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.
• MRI
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 Tasks
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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session).

External Links

•   Link to study record for experiment 7 [NCT05723575]