No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
80 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease to see how deep brain stimulation can help with controlling actions. Participants will be studied before, during, and after the stimulation procedure.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease
I am at Hoehn and Yahr stage 2-4
I have a clinical indication for deep brain stimulation surgery
I have a normal preoperative MRI
I can tolerate awake surgery
I have a functioning deep brain stimulation system
You may not be able to join if
I have severe tremor at rest or severe dyskinesia
I cannot hold my Parkinson's medications for research recordings
I have dementia
I do not speak English
I have a bleeding disorder
I have uncontrolled high blood pressure
I have heart disease
I have other medical conditions that increase surgical risk
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Patients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability…
Patients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability to inhibit actions.
Trial Locations
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Eligibility Criteria
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 caus…
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
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