← Back to Search

Deep Brain Stimulation

Directional Deep Brain Stimulation for Parkinson's Disease

N/A

Waitlist Available

Led By Harrison Walker, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Score of more than 6 for activities of daily living in the worst 'off' medication condition despite medical treatment, as assessed with the use of the MDS-UPDRS II (scores range from 0 to 52, with higher scores indicating worse functioning), or mild-to-moderate impairment in social and occupational functioning (score of 51 to 80% on the Social and Occupational Functioning Assessment Scale with scores ranging from 1 to 100 and lower scores indicating worse functioning)

Clinically definite, advanced idiopathic PD based on at least 2 of 3 cardinal PD features (tremor, rigidity, or bradykinesia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post surgery

Awards & highlights

Study Summary

This trial will test if a new type of brain implant can help treat movement disorders by targeting specific areas of the brain. The researchers will also look if there are certain electrical signals in the brain that can predict which areas of the brain will respond best to the implant.

Who is the study for?

This trial is for adults aged 18-70 with advanced Parkinson's Disease who've had symptoms for at least 4 years and experience significant disability despite medication. They must be healthy enough for surgery, have stable medication doses, show improvement on dopaminergic meds, and not need contralateral DBS within a year. Exclusions include severe depression, other neurological diseases, medical conditions that interfere with the study or require MRI, uncontrolled health issues like hypertension or heart disease.Check my eligibility

What is being tested?

The trial tests the Boston Scientific Vercise PC IPG with directional DBS lead to see if it improves Parkinson's symptoms. It also examines whether certain biomarkers can predict which electrode contacts will work best long-term. Participants are those already opting for routine DBS surgery targeting the subthalamic nucleus.See study design

What are the potential side effects?

Potential side effects of DBS may include headache, infection at the implant site, speech problems, balance issues, mood changes such as depression or anxiety; however specific side effects related to this device will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

My daily activities are severely impacted by my condition, even with medication.

Select...

I have Parkinson's with tremor, stiffness, or slow movement.

Select...

My condition has been present for over 4 years.

Select...

I am choosing to have DBS surgery targeting the STN as part of my standard treatment.

Select...

I am healthy enough for surgery and to follow the study's procedures.

Select...

I am willing and able to cooperate during awake brain surgery and follow-up care.

Select...

My health insurance or Medicare covers DBS surgery.

Select...

I am between 18 and 70 years old.

Select...

My Parkinson's disease is more advanced than just affecting one side of my body without much disability.

Select...

My mental function score is 130 or higher while on medication.

Select...

My depression score is 25 or less while on medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pharmaceutical Preparations

Treatment Preference Survey

Secondary outcome measures

Change from preoperative baseline in Acoustic Measures

Change from preoperative baseline in Activities-Specific Balance Confidence (ABC) Scale

Change from preoperative baseline in Gait Initiation Test

+38 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Directional DBS guided by behaviorActive Control1 Intervention

Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.

Group II: Directional DBS guided by biomarkersActive Control1 Intervention

Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).

Group III: Omnidirectional DBS guided by behaviorPlacebo Group1 Intervention

Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,989 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,548 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,350 Total Patients Enrolled

Media Library

Boston Scientific Vercise PC IPG with directional DBS lead (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03353688 — N/A

Parkinson's Disease Research Study Groups: Directional DBS guided by behavior, Omnidirectional DBS guided by behavior, Directional DBS guided by biomarkers

Parkinson's Disease Clinical Trial 2023: Boston Scientific Vercise PC IPG with directional DBS lead Highlights & Side Effects. Trial Name: NCT03353688 — N/A

Boston Scientific Vercise PC IPG with directional DBS lead (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03353688 — 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 aim of this experiment?

"The primary metric of this clinical study, which is to be assessed after 12 months post-surgery, is the Treatment Preference Survey. Secondary evaluations include an assessment of stigma sensitivity via the Neuro-QOL Item Bank v1.0 "Stigma" short form and a 'Satisfaction with Social Roles and Activities' analysis utilizing the Neuro-QOL Item Bank v1.1 scale; both are expected to compare preoperative baseline values against outcomes generated from the trial intervention. Additionally, changes in motor complications like OFF state dystonia will be observed through MDS Unified Parkinson's disease Rating Scale (UPDRS)"

Answered by AI

Are individuals aged 75 and younger eligible for the trial?

"This medical trial is searching for people aged between 18 and 70, with 27 studies focusing on minors and 487 aimed at elderly individuals."

Answered by AI

How many participants is the research team looking to recruit for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical research is actively recruiting participants, with the trial initially being posted on November 3rd 2017 and last edited August 24th 2022. 40 people are needed at one site for enrolment."

Answered by AI

Are there any opportunities to join this experiment currently available?

"This medical trial, which was initially listed on November 3rd 2017, is currently in search of participants. The most recent update to the study was made on August 24th 2022 according to clinicaltrials.gov."

Answered by AI

Is there an option for me to join this medical research?

"This medical trial is currently accepting 40 participants aged between 18 and 70 that are diagnosed with Parkinson's disease. Those wishing to enter must demonstrate their willingness to comply during the awake DBS surgery, post-operative assessments, medication adjustments and stimulator settings, agree not to undergo contralateral DBs for at least a year after initial operation, have refractory motor symptoms causing significant disability or job impairment despite adequate treatment attempts according certified by our consensus panel of experts; And be healthy enough to go through both the research protocol and surgical procedure all while being within the age range specified (18 - 70)."

Answered by AI

Recent research and studies

Parkinsonism & Related DisordersJournal

Nascent Visual Artistic Expression Following Right Hemisphere Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease

Black, Sarah D., Victor A. Del Bene, Andrea S. Celka, Barton Guthrie, Roy C. Martin, Joseph Olson, Jason Shumake, and Harrison C. Walker. 2022. “Nascent Visual Artistic Expression Following Right Hemisphere Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease”. Parkinsonism & Related Disorders. Elsevier BV. doi:10.1016/j.parkreldis.2022.04.020.

clinicaltrials.govStudy

Biomarkers to Guide Directional DBS for Parkinson's Disease

Harrison Walker, MD 2017. "Biomarkers to Guide Directional DBS for Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03353688.

All > Dbs > Parkinson