RightFit
RecruitingPhase 4

Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 18 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Healthy controls will attend two study visits, while patients with PD will be in the study for up to 18 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 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

Study sites (2)

GA