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New treatment option for Parkinson Disease
Official title Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
ClinicalTrials.gov ID: NCT06234995
What this study is testing
What is Levodopa?
Levodopa is an investigational medicine, being studied as a potential treatment for parkinson disease.
Also referred to as L-Dopa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.