Healthy Clinical Trial
Official title:
The Role of Cerebellum in Speech
This study will investigate the how the cerebellum is involved in speech motor learning over time and short-term corrections in patients with cerebellar ataxia and healthy controls. This will be accomplished through three approaches: behavioral studies, magnetic resonance imaging (MRI), and transcranial magnetic stimulation (TMS). During behavioral studies, participants will be asked to speak into a microphone while their voice is played back over earphones, and to do other speaking tasks. MRI will be acquired to perform a detailed analysis on brain function and anatomy related to speech and the cerebellum. In healthy controls, TMS will also be performed to temporarily disrupt the cerebellum before, during, or after the participant performs speaking tasks. Patients with cerebellar ataxia and healthy volunteers will be asked to complete behavioral studies and/or MRI; healthy volunteers may be asked to additionally participate in TMS.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | September 1, 2024 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion criteria: - Diagnosis of cerebellar ataxia (CA) resulting from degeneration of the cerebellum AND normal hearing abilities OR - Healthy volunteers with no known history of physical or neurological abnormalities AND normal speech, hearing, and reading abilities - For some studies, primary language of American English may be required Exclusion criteria for healthy volunteers: - Neurological impairment or psychiatric illness Exclusion criteria for participants with cerebellar ataxia (CA): - Neurological impairment or psychiatric illness apart from those arising from cerebellar damage Exclusion criteria for participants with CA or for healthy volunteers participating in MRI (may still be eligible for other study procedures): - Any contraindication to participating in an MRI study including the following: implanted metallic parts or implanted electronic devices, including pacemakers, defibrillators, stimulators, or implant medication pump, or nonremovable piercings; aneurysm clip or other metal in the head (except mouth); claustrophobia precluding MRI Exclusion criteria for healthy volunteers participating in TMS (may still be eligible for other study procedures): - Any contraindications to participating in a TMS study including the following: epilepsy, use of certain medications, heart disease, and pregnancy; scalp wounds or infections; any other contraindication discovered during screening procedures - Any contraindication to participating in an MRI study including the following: implanted metallic parts or implanted electronic devices, including pacemakers, defibrillators, or implant medication pump, or nonremovable piercings; claustrophobia precluding MRI Exclusion criteria for all potential participants: - Pregnant or trying to become pregnant (may still be eligible for behavioral studies only) - History of alcohol abuse, illicit drug use or drug abuse or significant mental illness - Hypertensive or hypotensive condition - Any condition that would prevent the subject from giving voluntary informed consent - Enrolled or plans to enroll in an interventional trial during this study - Ongoing seizures that are not well controlled despite medication - Use of hearing aid or other device to improve hearing |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Berkeley | Berkeley | California |
United States | University of Wisconsin--Madison | Madison | Wisconsin |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute on Deafness and Other Communication Disorders (NIDCD), University of California, Berkeley, University of Wisconsin, Madison |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Speech-motor response percent compensation | Percent compensation is calculated as the following ratio: -100*(change in acoustic feature produced by the subject)/(change in acoustic feature caused by auditory feedback alteration). The negative sign ensures that changes produced by the subject that oppose the auditory feedback alteration changes are counted as positive compensation. Acoustic features used to compute percent compensation depend on the experiment performed and will include pitch or formant frequencies of subjects' output speech (measured by frequency in Hz), voice onset time (measured in milliseconds), fricative consonant duration (measured in milliseconds), and formant transition time (measured in milliseconds). We will look for short-term (within-trial) and long-term (across-trial) changes in percent compensation produced by subjects in response to alterations in subjects' auditory feedback they hear while speaking. | Baseline | |
Primary | Dysarthria symptoms | Ataxic dysarthria (AD) symptoms will be quantified in patients with cerebellar ataxia (CA) by licensed speech-language pathologists using the Bogenhausen Dysarthria Scales (BoDyS), a dysarthria assessment tool that has been shown to be objective, reliable, and sensitive to dysarthria subtypes 31, 60, and 61. The BoDyS test entails 33 separate component ratings, including symptoms that may be related to feedforward and feedback components of speech motor control systems. | Baseline | |
Primary | Voxel-based morphometry (VBM) | VBM will be applied to explore the functional organization of the cerebellum for speech production, focusing on psychophysical measures of speech motor control as well as clinical measures of dysarthric speech symptoms. | Baseline |
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