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Procedure

STN DBS for Parkinson's Disease

N/A

Recruiting

Led By Tamara G Hershey

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Post-Surgical DBS Group: Males or females between 50 and 75 years of age who meet criteria for clinically definite PD and have had bilateral STN DBS surgery

Pilot Group: Males or females between 20 and 75 years of age who do not meet criteria for clinically definite PD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measures will be fully available at the end of this 5 yr study

Awards & highlights

Study Summary

This trial will use high-density diffuse optical tomography (HD-DOT) to investigate how STN DBS modulates cortical functional networks and behavior in PD patients in order to improve clinical optimization of DBS.

Who is the study for?

This trial is for adults with Parkinson's Disease (PD) who are either planning to have, or have already had, deep brain stimulation surgery in the subthalamic nucleus. It includes those aged 50-75 and a control group without PD matched by age and sex. Exclusions include significant neurological/psychiatric conditions, MRI contraindications, severe visual loss, non-English speakers, and illiteracy.Check my eligibility

What is being tested?

The study tests how STN DBS affects cortical networks related to movement and cognition using HD-DOT scanning technology. This could improve DBS clinical optimization and identify new targets for neuromodulation therapy. Participants will undergo motor/cognitive tests, questionnaires, HD-DOT scans, and MRIs.See study design

What are the potential side effects?

While this study focuses on imaging rather than drug side effects, participants may experience discomfort from testing procedures or potential risks associated with MRI scans such as claustrophobia or reactions to contrast agents if used.

Eligibility Criteria

Inclusion Criteria

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

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I am between 50-75 years old, diagnosed with Parkinson's, and have had DBS surgery.

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I am between 20 and 75 years old and do not have a definite diagnosis of Parkinson's disease.

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I am between 50 and 75 years old, diagnosed with Parkinson's, and approved for deep brain stimulation surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measures will be fully available at the end of this 5 yr study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measures will be fully available at the end of this 5 yr study

This trial's timeline: 3 weeks for screening, Varies for treatment, and measures will be fully available at the end of this 5 yr study for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Functional Connectivity measures

Trial Design

1Treatment groups

Experimental Treatment

Group I: Post-Surgical GroupExperimental Treatment1 Intervention

STN DBS: Subjects with PD and DBS STN implanted will be scanned and tested with DBS ON and OFF

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STN DBS

2011

Completed Phase 2

~40

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,656 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,289 Total Patients Enrolled

Tamara G HersheyPrincipal InvestigatorWashington University Medical School

Media Library

STN DBS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04922411 — N/A

Parkinson's Disease Research Study Groups: Post-Surgical Group

Parkinson's Disease Clinical Trial 2023: STN DBS Highlights & Side Effects. Trial Name: NCT04922411 — N/A

STN DBS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04922411 — N/A

Frequently Asked Questions

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

Who could benefit from participating in this clinical research?

"Prerequisites for this trial are that the patient must have Parkinson's disease, be between 25 and 75 years of age, and there is a total capacity of 100 participants."

Answered by AI

What is the aggregate number of participants enrolled in this research project?

"Affirmative. Evidenced by clinicaltrials.gov, this research is actively recruiting members. Originally posted on April 23rd 2021 and updated last June 7th 2022, the investigation calls for 100 participants at a single site."

Answered by AI

Is the research program currently seeking participants?

"According to the clinicaltrials.gov website, this experiment is currently accepting new participants. It was first made public on April 23rd 2021 and has been revised as recently as June 7th 2022."

Answered by AI

Are elderly individuals being sought for participation in this healthcare experiment?

"As this trial's inclusion criteria states, it is open to people between the ages of 25 and 75. For those that are younger than 18 or older than 65 there are 27 trials exclusively for minors and 491 studies targeting seniors respectively."

Answered by AI

Is it estimated that this investigation will last longer than 12 months?

"This protocol is expected to span a total of five years and encompass three distinct phases: screening, treatment, and documentation. With each stage having its own timeline, the duration for participant assessment should take about three weeks; whereas therapeutic intervention and post-treatment follow-up are slated to last 5 Years apiece."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cortical Network Modulation by Subthalamic Nucleus DBS

2021. "Cortical Network Modulation by Subthalamic Nucleus DBS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922411.

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