N/A
N=17
Behavioral and Neural Responses to External Alterations of Speech Variability
Speech
Bottom Line
View on ClinicalTrials.gov: NCT05286658 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: 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 — 7.4; -22.2; 28.9 percent change (of z-score difference)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MEG/EEG (Behavioral); MRI (Behavioral); Speaking Tasks (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
7.4; -22.2; 28.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05286658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.