Speech Clinical Trial
Official title:
Behavioral and Neural Measures of Speech Motor Control
Verified date | January 2024 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
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). |
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