Understanding how deep brain stimulation affects decision-making in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of deep brain stimulation (DBS) on executive functions in patients with Parkinson's Disease (PD). It examines how the location of stimulation and the size of the electrical field produced by DBS influence the brain circuits involved in response inhibition. Patients will be assessed before, during, and after the DBS implantation procedure to determine the impact on their ability to control impulsive actions. The research aims to shed light on the relationship between DBS and cognitive functions critical for daily decision-making.

Why it matters

Who can join: the full rules

Inclusion Criteria for Persons with Parkinson's Disease for Aim 1:

* diagnosis of idiopathic Parkinson's disease (PD)
* Hoehn and Yahr (H\&Y) stage 2-4 (off medication)

Exclusion Criteria for Persons with Parkinson's Disease for Aim 1:

* severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
* inability to hold antiparkinsonian medications for research recordings
* dementia
* non-English speaker

Inclusion Criteria for Persons with Parkinson's Disease for Aim 2:

* diagnosis of idiopathic PD
* there is a clinical indication for DBS surgery
* normal preoperative MRI
* ability to tolerate microelectrode-guided neurosurgery in an awake state

Exclusion Criteria for Persons with Parkinson's Disease for Aim 2:

* presence of a coagulopathy
* uncontrolled hypertension
* heart disease
* other medical conditions considered to increase the patient's risk for surgical complications

Inclusion Criteria for Persons with Parkinson's Disease for Aim 3:

* diagnosis of idiopathic PD
* functioning DBS system

Exclusion Criteria for Persons with Parkinson's Disease for Aim 3:

* severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
* inability to hold antiparkinsonian medications for research recordings
* inability to tolerate temporary discontinuation of DBS therapy or alteration of stimulation settings for research purposes
* other medical conditions considered to increase the patient's risk for surgical complications

Inclusion Criteria for Healthy Controls:

* age 45-75

Exclusion Criteria for Healthy Controls:

* history of a neuropsychiatric disorder and/or treatment with psychotropic medications
* non-English speaker

Where it's running

• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Emory Brain Health Center
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Svjetlana Miocinovic, MD, PhD — Emory University
• Study coordinator: Jonna Seppa
• Email: jonna.k.seppa@emory.edu
• Phone: 404-727-1509

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.