Recruiting

STN-DBS

Sponsor:

Jeremy Greenlee

Code:

NCT05493670

Conditions

Parkinson Disease

Dysarthria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05493670

Start date

Oct 15, 2020

Status verified date

Dec, 2023

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Neuron Firing Rate [ Time Frame: Intraoperatively ]

Central Contacts and Locations

Central contacts

Jeremy Greenlee, MD

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

Annie Rohl, MS

andrea-rohl@uiowa.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jeremy Greenlee, MD

319-356-2771

Annie Rohl, MS

andrea-rohl@uiowa.edu

More Information

Sponsor

Jeremy Greenlee

Last update posted

Dec 22, 2023

Last verified

Dec, 2023

Keywords

  • Deep Brain Stimulation
  • Parkinson
  • Speech
  • Movement
  • Intelligibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jeremy Greenlee on 2023-12-22.