Subthalamic Nucleus Deep Brain Stimulation in Speech Study

NCT05493670 | Unknown

• 2 other identifiers: 202001213R01DC017718
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Dysarthria

Keywords

Deep Brain Stimulation; Parkinson; Speech; Movement; Intelligibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Speech Intelligibility with DBS ON

  Speech intelligibility with DBS ON will be measured at the 6 month follow up and 12 month follow up for the DBS-STN group.

• Speech Intelligibility (stimulation OFF or not applicable)

  Speech intelligibility without stimulation will be measured at baseline, 6 month, and 12 month visits for all participants.

Study Arms (2)

DBS-STN

The DBS-STN group will consist of individuals with Parkinson's disease who have already elected to undergo deep brain stimulation surgery.

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.

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 80 STN-DBS participants and 40 participants with Parkinson's disease to serve as non-surgical controls. All Parkinson's disease patients judged to be candidates for DBS surgery by the implanting neurosurgeon and movement disorder neurologists who decide to undergo bilateral surgery will be considered candidates for the study. Control subjects must have a diagnosis of Parkinson's disease and no plan to undergo DBS surgery.

You may qualify if:

• 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

You may not qualify if:

• Significant hearing loss/reliance on hearing aids

Sponsors & Collaborators

• Jeremy Greenlee: lead
• National Institutes of Health (NIH): collaborator
• University of Pittsburgh: collaborator
• University at Buffalo: collaborator
• Northwestern University: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 29456879 BACKGROUND

• 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.

  PMID: 27003219 BACKGROUND

• 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.

  PMID: 23227426 BACKGROUND

• 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.

  PMID: 20697699 BACKGROUND

• 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.

  PMID: 23667281 BACKGROUND

• 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.

  PMID: 28505983 BACKGROUND

• 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.

  PMID: 11344014 BACKGROUND

• 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.

  PMID: 29789378 BACKGROUND

• 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.

  PMID: 21782543 BACKGROUND

• 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.

  PMID: 22173017 BACKGROUND

• 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.

  PMID: 11104196 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dysarthria; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Study Officials

• Jeremy Greenlee, MD

  University of Iowa Dept of Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Greenlee, MD

CONTACT

319-356-2771; jeremy-greenlee@uiowa.edu

Annie Rohl, MS

CONTACT

andrea-rohl@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: August 9, 2022
• Study Start: October 15, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)