Parkinson Disease Clinical Trial
— SiSSOfficial title:
Role of Subthalamic Nucleus in Speech and Movement Among People With Parkinson's Disease as Revealed by Intraoperative Recordings and Deep Brain Stimulation
Parkinson's disease (PD) patients treated with deep brain stimulation (DBS) of the subthalamic nucleus (STN) have unpredictable and varied speech outcomes after this treatment. Our research will prospectively document speech performance before, during and 6- and 12-months after STN-DBS in 80 surgically treated patients and compared with 40 non-surgical controls with Parkinson's disease. This study will provide unique insights into the role of STN in speech production, document speech outcome in a comprehensive fashion, identify factors that predict functional communication ability 12 months after STN-DBS, and test the feasibility of low frequency DBS in reversing DBS-induced speech declines in order to optimize treatment strategies for those living with Parkinson's disease.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 84 Years |
Eligibility | Inclusion Criteria: For inclusion in this study, participants must - 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: - Significant hearing loss/reliance on hearing aids |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Jeremy Greenlee | National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), Northwestern University, University at Buffalo, University of Pittsburgh |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neuron Firing Rate | DBS-STN participants will complete simple speech and motor tasks during surgery while the surgeon records neuron firing rate using Microelectrode Recording (MER). | Intraoperatively | |
Secondary | Speech Intelligibility with DBS ON | Speech intelligibility will be measured using the Sentence Intelligibility Test (SIT). Speech intelligibility ratings are measured as percentages, with lower percentages indicating more severe speech impairments. | Speech intelligibility with DBS ON will be measured at the 6 month follow up and 12 month follow up for the DBS-STN group. | |
Secondary | Speech Intelligibility (stimulation OFF or not applicable) | Speech intelligibility will be measured using the Sentence Intelligibility Test (SIT). Speech intelligibility ratings are measured as percentages, with lower percentages indicating more severe speech impairments. | Speech intelligibility without stimulation will be measured at baseline, 6 month, and 12 month visits for all participants. |
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