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Deep Brain Stimulation

Deep Brain Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Kiarash Shahlaie, MD, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system

Individuals who are 18 years and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, hour 24, week 1, month 1, month 2, month 4, and month 5

Awards & highlights

Study Summary

This trialwill test if stimulating the brain with low frequency in Parkinson's patients can improve their cognitive control.

Who is the study for?

This trial is for adults with advanced Parkinson's Disease who have had a specific type of deep brain stimulation (DBS) surgery using the Boston Scientific VerciseTM system. They must be able to consent, participate in cognitive tests, and not have severe cognitive or physical impairments.Check my eligibility

What is being tested?

The study is testing low frequency stimulation of the ventral STN alongside standard high frequency stimulation of the dorsal STN in patients with Parkinson's. It aims to see if this can improve cognition without worsening motor symptoms.See study design

What are the potential side effects?

Potential side effects may include changes in mood or behavior, headache, dizziness, difficulty concentrating, and other neurological effects related to DBS adjustments.

Eligibility Criteria

Inclusion Criteria

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

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I have Parkinson's and received a Boston Scientific Vercise DBS implant.

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I am 18 years old or older.

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I have advanced Parkinson's and underwent DBS surgery targeting the STN for motor improvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, hour 24, week 1, month 1, month 2, month 4, and month 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, hour 24, week 1, month 1, month 2, month 4, and month 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, hour 24, week 1, month 1, month 2, month 4, and month 5 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA)

Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10)

Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)

+4 more

Secondary outcome measures

Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task

Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task

Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sustained Dual Frequency, Dual Region, StimulationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deep brain stimulation

2010

Completed Phase 3

~380

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,509 Total Patients Enrolled

Kiarash Shahlaie, MD, PhDPrincipal InvestigatorUniversity of California, Davis

Media Library

Dual Frequency Stimulation (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04650932 — N/A

Parkinson's Disease Research Study Groups: Sustained Dual Frequency, Dual Region, Stimulation

Parkinson's Disease Clinical Trial 2023: Dual Frequency Stimulation Highlights & Side Effects. Trial Name: NCT04650932 — N/A

Dual Frequency Stimulation (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04650932 — N/A

Frequently Asked Questions

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

Are any additional participants needed for this experiment?

"This is accurate. According to clinicaltrials.gov, this research study was first announced on October 22nd 2022 and has since been updated on December 21st 2022. Currently, 10 patients are required to be enrolled at one site for the trial's success."

Answered by AI

How many participants is this clinical trial currently recruiting?

"Indeed, the information on clinicaltrials.gov affirms that this research endeavor is actively recruiting participants. This trial was first publicized on October 22nd 2022 and last updated December 21st of the same year. The study necessitates 10 volunteers from a single medical centre."

Answered by AI