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Procedure

Patients with Parkinson's Disease for Parkinson's Disease

Phase 4

Recruiting

Led By Svjetlana Miocinovic, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 45-75

Diagnosis of idiopathic Parkinson's disease (PD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-implantation of dbs leads

Awards & highlights

Study Summary

This trial aims to study patients with Parkinson's Disease to see if a procedure called deep brain stimulation (DBS) can improve their ability to control their actions. The researchers will look at the location and

Who is the study for?

This trial is for individuals with Parkinson's Disease who are undergoing deep brain stimulation (DBS) implantation. The study aims to understand how different DBS settings affect executive functions involving the prefrontal cortex, particularly action inhibition.Check my eligibility

What is being tested?

The study tests various DBS settings and Levodopa medication on patients' response inhibition. It compares clinical DBS, a setting minimizing prefrontal activation, one maximizing it, and a sham (placebo) procedure to see which has the best impact on executive function.See study design

What are the potential side effects?

Potential side effects may include discomfort from the device or surgery, changes in mood or cognition due to stimulation of brain areas during DBS adjustment, and typical Levodopa-related side effects like nausea or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 75 years old.

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I have been diagnosed with Parkinson's disease.

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I am recommended to have deep brain stimulation surgery.

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My Parkinson's disease is at a moderate to severe stage without medication.

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I can undergo brain surgery while awake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-implantation of dbs leads

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-implantation of dbs leads

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-implantation of dbs leads for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of Errors During Go/No-Go (GNG) Task for Participants in Aim 1

Percent of Errors During Go/No-Go (GNG) Task for Participants in Aim 3

Response Time During Go/No-Go (GNG) Task for Participants in Aim 1

+3 more

Secondary outcome measures

Electrocorticography (ECoG) Signals During GNG for Participants in Aim 2

Electroencephalogram (EEG) Signals During GNG for Participants in Aim 1

Electroencephalogram (EEG) Signals During GNG for Participants in Aim 3

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patients with Parkinson's DiseaseExperimental Treatment5 Interventions

Patients with PD complete motor response inhibitions tasks under multiple conditions, depending on the study aim they are participating in. Those who are participants in Aim 1 of the study are able to also participate in Aims 2 and 3 if they are having a clinically indicated DBS leads implanted. Patients with PD will participate in the study for approximately 18 months which includes one preoperative visit, intraoperative data collection and two post-operative visits. As part of the motor inhibition tasks, EEG signals will be recorded. A cap similar to a swim cap will be placed on the head of the subject, and gel will be applied to the hair to get a good signal. Electrodes will be attached to the cap for recording of brain signals. A few additional flat electrodes will be placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors will be utilized to record arm movements (for MSS task).

Group II: Healthy ControlsActive Control1 Intervention

Healthy participants complete motor response inhibition tasks during two study visits. Healthy controls will participate for approximately one month, which includes two study visits. As part of the motor inhibition tasks, EEG signals will be recorded. A cap similar to a swim cap will be placed on the head of the subject, and gel will be applied to the hair to get a good signal. Electrodes will be attached to the cap for recording of brain signals. A few additional flat electrodes will be placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors will be utilized to record arm movements (for MSS task).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levodopa

2016

Completed Phase 4

~2050

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,509 Total Patients Enrolled

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,577 Total Patients Enrolled

Svjetlana Miocinovic, MD, PhDPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this clinical trial still ongoing?

"The current status of this trial, as outlined on clinicaltrials.gov, indicates that it is actively enrolling participants. The study was initially posted on August 9th, 2021 and last updated on January 23rd, 2024."

Answered by AI

What is the current number of participants involved in this research trial?

"Indeed, as per details on clinicaltrials.gov, this investigation is actively seeking participants. The trial was first listed on August 9th, 2021 and last revised on January 23rd, 2024. Enrollment targets are set at 80 individuals across two designated sites."

Answered by AI

Is the research study open to individuals under the age of 25?

"Individuals aged between 45 and 75 are sought for participation in this investigation. It is noted that there are a total of 22 trials targeting subjects under the age of 18, while an additional 499 studies focus on individuals over the age of 65."

Answered by AI

What are the safety considerations for individuals with Parkinson's Disease undergoing treatment?

"Our experts at Power have rated the safety of Parkinson's disease patients as a 3 on our scale. This rating is based on this trial being classified as Phase 4, indicating that the treatment has regulatory approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Svjetlana Miocinovic 2021. "Cortical Electrophysiology of Response Inhibition in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06234995.

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