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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
Must not have
Post-Surgical DBS Group: Exclusions include contraindications for MRI pre-surgically, clinically determined dementia manifesting after surgery, significant complications of surgery, inability to tolerate off medication or off DBS states, and conditions interfering with testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measures will be fully available at the end of this 5 yr study
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have MRI issues, dementia post-surgery, surgery complications, or conditions affecting tests.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Connectivity measures

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,784 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,737 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
~28 spots leftby Apr 2026
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