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Deep Brain Stimulation

Deep Brain Stimulation for Parkinson's Disease

N/A
Waitlist Available
Led By Ryan Uitti, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parkinson's Disease (PD) patients in whom optimal medical therapy has failed
Individuals with normal or mild cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights

Study Summary

This trial is testing if a new treatment that targets both sides of the brain could improve cognitive function in patients with Parkinson's disease.

Who is the study for?
This trial is for Parkinson's Disease patients who respond to levodopa treatment, have normal or mild cognitive issues, and haven't had success with standard medical therapies. It's not open to those with significant dementia, other major neurological or psychiatric conditions, previous brain surgeries like pallidotomy/thalamotomy, or existing implantable devices.Check my eligibility
What is being tested?
The study tests if stimulating two brain areas (subthalamic nucleus and fornix/hypothalamus) at the same time can improve thinking abilities in Parkinson's patients. This dual stimulation technique is a new approach being piloted.See study design
What are the potential side effects?
Deep brain stimulation may cause side effects such as headache, confusion, speech problems, balance issues, tingling sensations or muscle stiffness. There might also be risks associated with the surgery needed to place the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Parkinson's symptoms have not improved despite trying the best treatments.
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My thinking and memory skills are normal or slightly impaired.
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My condition improves with levodopa treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in memory testing from presurgical baseline to 12 months

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,039 Total Patients Enrolled
Ryan Uitti, M.D.Principal InvestigatorMayo Clinic

Media Library

Tandem DBS (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT01563341 — N/A
Parkinson's Disease Research Study Groups: Deep Brain Stimulation
Parkinson's Disease Clinical Trial 2023: Tandem DBS Highlights & Side Effects. Trial Name: NCT01563341 — N/A
Tandem DBS (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01563341 — N/A

Frequently Asked Questions

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

Am I eligible to enroll in this clinical research?

"This experiment is looking to recruit 12 people with Parkinson's disease (PD) between 40 and 80 years old. Essential criterion for enrolment includes normal or slight cognitive impairment, as well as being associated with the primary investigator's practice."

Answered by AI

Is this research program open to new participants?

"Per the clinicaltrials.gov database, this medical experiment is no longer recruiting participants despite being initially posted on April 1st, 2012 and last updated May 10th 2022. Fortunately, 496 other trials are presently accepting volunteer patients for participation."

Answered by AI

Is participation of individuals over 35 years old encouraged for this medical trial?

"The age limits for this trial have been set at 40 and 80 years old respectively, per the eligibility criteria."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Jan 2025