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Brain Stimulation

Brain Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Darrin Lee, MD PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation

Stable medication regimen for at least 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 2, week 3, week 15, week 27

Awards & highlights

Study Summary

This trial will help researchers understand if direct brain stimulation can improve cognition in PD patients with a deep brain stimulator.

Who is the study for?

This trial is for adults over 18 with Parkinson's Disease who already have a deep brain stimulator implanted. They must be on stable medication for at least three months and able to consent and follow the study plan. People with epilepsy, dementia, or major substance abuse history cannot join.Check my eligibility

What is being tested?

The study tests if changing how the brain stimulator works can improve thinking skills in Parkinson's patients. It involves two types of stimulation (Theta Burst and Gamma) and checks their effects using cognitive tests and fMRI scans at different times.See study design

What are the potential side effects?

Since this trial adjusts existing brain stimulators, side effects may include discomfort from changes in stimulation, headache, dizziness or temporary worsening of Parkinson’s symptoms during adjustment periods.

Eligibility Criteria

Inclusion Criteria

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

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I have had deep brain stimulation implants in both sides of my brain.

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My medication has not changed in the last 3 months.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 2, week 3, week 15, week 27

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 2, week 3, week 15, week 27

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 3, week 15, week 27 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluation of executive functioning

Evaluation of motor symptoms

Neuroimaging

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment2 Interventions

double blinded randomization into baseline stimulation followed by theta burst stimulation

Group II: Group AExperimental Treatment2 Interventions

double-blinded randomization into theta burst stimulation followed by baseline stimulation

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,246 Total Patients Enrolled

Darrin Lee, MD PhDPrincipal InvestigatorUniversity of Southern California, Keck School of Medicine

Media Library

STN DBS - Gamma (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05307055 — N/A

Parkinson's Disease Research Study Groups: Group A, Group B

Parkinson's Disease Clinical Trial 2023: STN DBS - Gamma Highlights & Side Effects. Trial Name: NCT05307055 — N/A

STN DBS - Gamma (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307055 — N/A

Frequently Asked Questions

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

What is the upper-limit of participants in this experiment?

"Indeed, the study is actively recruiting according to clinicaltrials.gov's records. The trial was first published on November 1st 2022 and recently edited on March 22nd 2022 with plans for 32 patients at a single site."

Answered by AI

Are additional volunteers being sought in this experiment?

"As indicated by the clinicaltrials.gov listing, this trial is currently recruiting subjects. The initial post was on November 1st 2022, with the latest update to the study occurring March 22nd of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation

Darrin J Lee, MD, PhD 2022. "Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05307055.

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