Subthalamic Nucleus Deep Brain Stimulation in Speech Study
NCT ID: NCT05493670
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2020-10-15
2025-07-31
Brief Summary
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Detailed Description
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Aim 2. Advance understanding of speech outcomes associated with STN-DBS. Intelligibility will serve as the primary functional communication outcome, with communication participation as a secondary metric. Acoustic measures of articulation, phonatory-respiratory behavior and tempo-fluency will be obtained.
Aim 2A. Determine differential effects of DBS stimulation (ON vs. OFF) on speech outcomes. ON vs. OFF stimulation changes in acoustic measures of speech will be used to inform potential reasons for observed changes in intelligibility.
Aim 2B. Define longitudinal effects of STN-DBS on speech outcomes. Speech outcomes and limb measures obtained pre-surgery will be compared to those at 6 and 12 months post-surgery when DBS stimulation is ON. Change in communication participation also will be defined. The control group studied at similar time points will control for disease progression.
Aim 2C. Determine associations between acoustic measures and intelligibility in STN-DBS.
Aim 3. Explore factors associated with changes in intelligibility post STN-DBS. As initial endeavors to guide future studies, we will:
Aim 3A. Use our metrics from Aims 1 and 2 (e.g. disease-specific characteristics, microelectrode recording data, pre-operative intelligibility) to identify factors that predict intelligibility at 12 months following STN-DBS.
Aim 3B. Test the feasibility of manipulating DBS stimulation parameters to improve intelligibility in a subset of participants with DBS-induced intelligibility declines.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DBS-STN
The DBS-STN group will consist of individuals with Parkinson's disease who have already elected to undergo deep brain stimulation surgery.
No interventions assigned to this group
Control
The control group will consist of individuals with Parkinson's disease who are not undergoing deep brain stimulation placement. No interventions will be completed with the control group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* have a confirmed diagnosis of idiopathic Parkinson's disease and no atypical Parkinsonism features
* experience significant motor fluctuations
* currently taking and responsive to dopaminergic medications (e.g. Levodopa)
* use English as their primary language
* lack significant cognitive impairment and be able to consent to participate
Exclusion Criteria
21 Years
84 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of Pittsburgh
OTHER
University at Buffalo
OTHER
Northwestern University
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Jeremy Greenlee
OTHER
Responsible Party
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Jeremy Greenlee
Professor of Neurosurgery
Principal Investigators
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Jeremy Greenlee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Dept of Neurosurgery
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Jeremy Greenlee, MD
Role: primary
Annie Rohl, MS
Role: backup
References
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Sidtis D, Sidtis JJ. Subcortical Effects on Voice and Fluency in Dysarthria: Observations from Subthalamic Nucleus Stimulation. J Alzheimers Dis Parkinsonism. 2017;7(6):392. doi: 10.4172/2161-0460.1000392. Epub 2017 Oct 30.
Sidtis JJ, Alken AG, Tagliati M, Alterman R, Van Lancker Sidtis D. Subthalamic Stimulation Reduces Vowel Space at the Initiation of Sustained Production: Implications for Articulatory Motor Control in Parkinson's Disease. J Parkinsons Dis. 2016 Mar 19;6(2):361-70. doi: 10.3233/JPD-150739.
Skodda S. Effect of deep brain stimulation on speech performance in Parkinson's disease. Parkinsons Dis. 2012;2012:850596. doi: 10.1155/2012/850596. Epub 2012 Nov 21.
Sturman MM, Vaillancourt DE, Metman LV, Bakay RA, Corcos DM. Effects of five years of chronic STN stimulation on muscle strength and movement speed. Exp Brain Res. 2010 Sep;205(4):435-43. doi: 10.1007/s00221-010-2370-8. Epub 2010 Aug 10.
Tourville JA, Guenther FH. The DIVA model: A neural theory of speech acquisition and production. Lang Cogn Process. 2011 Jan 1;26(7):952-981. doi: 10.1080/01690960903498424.
Dayal V, Limousin P, Foltynie T. Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease: The Effect of Varying Stimulation Parameters. J Parkinsons Dis. 2017;7(2):235-245. doi: 10.3233/JPD-171077.
Pal PK, Lee CS, Samii A, Schulzer M, Stoessl AJ, Mak EK, Wudel J, Dobko T, Tsui JK. Alternating two finger tapping with contralateral activation is an objective measure of clinical severity in Parkinson's disease and correlates with PET. Parkinsonism Relat Disord. 2001 Oct;7(4):305-309. doi: 10.1016/s1353-8020(00)00048-1.
Lipski WJ, Alhourani A, Pirnia T, Jones PW, Dastolfo-Hromack C, Helou LB, Crammond DJ, Shaiman S, Dickey MW, Holt LL, Turner RS, Fiez JA, Richardson RM. Subthalamic Nucleus Neurons Differentially Encode Early and Late Aspects of Speech Production. J Neurosci. 2018 Jun 13;38(24):5620-5631. doi: 10.1523/JNEUROSCI.3480-17.2018. Epub 2018 May 22.
Seifried C, Weise L, Hartmann R, Gasser T, Baudrexel S, Szelenyi A, van de Loo S, Steinmetz H, Seifert V, Roeper J, Hilker R. Intraoperative microelectrode recording for the delineation of subthalamic nucleus topography in Parkinson's disease. Brain Stimul. 2012 Jul;5(3):378-387. doi: 10.1016/j.brs.2011.06.002. Epub 2011 Jul 8.
Hebb AO, Darvas F, Miller KJ. Transient and state modulation of beta power in human subthalamic nucleus during speech production and finger movement. Neuroscience. 2012 Jan 27;202:218-33. doi: 10.1016/j.neuroscience.2011.11.072. Epub 2011 Dec 6.
Dromey C, Kumar R, Lang AE, Lozano AM. An investigation of the effects of subthalamic nucleus stimulation on acoustic measures of voice. Mov Disord. 2000 Nov;15(6):1132-8. doi: 10.1002/1531-8257(200011)15:63.0.co;2-o.
Other Identifiers
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202001213
Identifier Type: -
Identifier Source: org_study_id