NCT05286658

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 13, 2024

Completed
Last Updated

February 13, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

March 9, 2022

Results QC Date

July 18, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

speech motor controlvocal learning

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (1)

Healthy Adult Speakers

EXPERIMENTAL

healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+

Behavioral: MEG/EEGBehavioral: MRIBehavioral: Speaking Tasks

Interventions

MEG/EEGBEHAVIORAL

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.

Also known as: magnetoencephalogram / electroencephalogram
Healthy Adult Speakers
MRIBEHAVIORAL

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.

Also known as: magnetic resonance imaging
Healthy Adult Speakers
Speaking TasksBEHAVIORAL

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.

Healthy Adult Speakers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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
  • Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)
  • Increased risk in the event of a seizure
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

MeSH Terms

Conditions

Speech

Interventions

MagnetoencephalographyMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Results Point of Contact

Title
Carrie Niziolek, PhD
Organization
University of Wisconsin - Madison

Study Officials

  • Carrie Niziolek, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 18, 2022

Study Start

October 19, 2021

Primary Completion

July 19, 2022

Study Completion

July 19, 2022

Last Updated

February 13, 2024

Results First Posted

February 13, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Locations