An observational study in Parkinson Disease and Dysarthria, sponsored by Jeremy Greenlee. Status unknown at 1 site in United States. Open to participants aged 21 Years to 84 Years. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Jeremy Greenlee · Observational
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.
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.
4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 120 is above the median of 97 across 1,081 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Jeremy Greenlee as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For inclusion in this study, participants must
Exclusion Criteria:
The DBS-STN group will consist of individuals with Parkinson's disease who have already elected to undergo deep brain stimulation surgery.
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.
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).
Time frame: Intraoperatively
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.
Time frame: 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 will be measured using the Sentence Intelligibility Test (SIT). Speech intelligibility ratings are measured as percentages, with lower percentages indicating more severe speech impairments.
Time frame: Speech intelligibility without stimulation will be measured at baseline, 6 month, and 12 month visits for all participants.
Plan to share: No
Started Oct 2020 (actual). Primary completion is estimated for Jul 2025, 57 months after the start.
Of 381 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 57 months is above that.
Counting every sponsor, half of 440 studies reached it within 48 months; a quarter within 21 and three quarters within 112.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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