Parkinson Disease study: Levodopa vs Clinical DBS Setting
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 a medicine being studied to help manage symptoms of Parkinson Disease. Levodopa is designed to be converted into dopamine in the brain to help control movement.
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
- The study wants to find out whether the location and electrical field size of subthalamic nucleus deep brain stimulation influence brain circuits that control action inhibition.
- Who it's for
- People with Parkinson's disease who are having deep brain stimulation surgery.
- What's involved
- Participants will have brain activity recorded and tests of action‑stopping ability before, during, and after the implantation procedure.
- Time commitment
- The study follows the surgery and includes several assessment visits around the operation.
- 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
- diagnosis of idiopathic Parkinson's disease (PD)
- Hoehn and Yahr (H\&Y) stage 2-4 (off medication)
You likely can't join if
- severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
- inability to hold antiparkinsonian medications for research recordings
- dementia
- diagnosis of idiopathic PD
- there is a clinical indication for DBS surgery
- normal preoperative MRI
See the full eligibility criteria
- diagnosis of idiopathic Parkinson's disease (PD)
- Hoehn and Yahr (H\&Y) stage 2-4 (off medication)
- severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
- inability to hold antiparkinsonian medications for research recordings
- dementia
- diagnosis of idiopathic PD
- there is a clinical indication for DBS surgery
- normal preoperative MRI
- presence of a coagulopathy
- uncontrolled hypertension
- heart disease
- diagnosis of idiopathic PD
- 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
- history of a neuropsychiatric disorder and/or treatment with psychotropic medications
- non-English speaker
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.