Clinical trial NCT05493670: Subthalamic Nucleus Deep Brain Stimulation in Speech Study
Official title: Role of Subthalamic Nucleus in Speech and Movement Among People With Parkinson's Disease as Revealed by Intraoperative Recordings and Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Dysarthria
Keywords: Deep Brain Stimulation
Parkinson
Speech
Movement
Intelligibility
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Pittsburgh
name: University at Buffalo
name: Northwestern University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuron Firing Rate
timeFrame: Intraoperatively
Secondary outcomes:
measure: Speech Intelligibility with DBS ON
timeFrame: Speech intelligibility with DBS ON will be measured at the 6 month follow up and 12 month follow up for the DBS-STN group.
measure: Speech Intelligibility (stimulation OFF or not applicable)
timeFrame: Speech intelligibility without stimulation will be measured at baseline, 6 month, and 12 month visits for all participants.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa Dept of Neurosurgery
name: Jeremy Greenlee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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