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Subthalamic Nucleus Deep Brain Stimulation in Speech Study

Role of Subthalamic Nucleus in Speech and Movement Among People With Parkinson's Disease as Revealed by Intraoperative Recordings and Deep Brain Stimulation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05493670
Acronym
SiSS
Enrollment
120
Registered
2022-08-09
Start date
2020-10-15
Completion date
2025-07-31
Last updated
2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysarthria, Parkinson Disease

Keywords

Deep Brain Stimulation, Parkinson, Speech, Movement, Intelligibility

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.

Detailed description

Aim 1. Define the mechanistic role of STN in speech using direct intraoperative brain recordings. For the first time, we will define STN neuronal physiology for both speech and limb tasks. Through multichannel microelectrode recording (MER) during awake STN-DBS implantation surgery, we will test the hypothesis suggested by our pilot data that STN firing rate during speech will be significantly different from the firing rate during a limb motor task. 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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Pittsburgh
CollaboratorOTHER
University at Buffalo
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
Jeremy Greenlee
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neuron Firing RateIntraoperativelyDBS-STN participants will complete simple speech and motor tasks during surgery while the surgeon records neuron firing rate using Microelectrode Recording (MER).

Secondary

MeasureTime frameDescription
Speech Intelligibility with DBS ONSpeech 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 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 (stimulation OFF or not applicable)Speech intelligibility without stimulation will be measured at baseline, 6 month, and 12 month visits for all participants.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.

Countries

United States

Contacts

Primary ContactJeremy Greenlee, MD
jeremy-greenlee@uiowa.edu319-356-2771
Backup ContactAnnie Rohl, MS
andrea-rohl@uiowa.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026