Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
Recruiting · NCT06234995 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
Clinical DBS SettingDBS Setting Maximizing Prefrontal ActivationDBS Setting Minimizing Prefrontal ActivationLevodopaSham DBS
What this trial is about
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.
Who can take part
Age range
45 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 1 US state.
- Emory University Hospital - Atlanta, Georgia, United States
- Emory Brain Health Center - Atlanta, Georgia, United States