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Procedure

Deep Brain Stimulation for Parkinson's Disease and Essential Tremor

N/A
Waitlist Available
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during the 8 hour office visit
Awards & highlights

Study Summary

This trial will help researchers learn more about how DBS affects the brain, which could improve treatments for Parkinson's and essential tremor.

Who is the study for?
This trial is for people aged 40-80 with Parkinson's Disease or Essential Tremor, who've had the condition for at least 4 years and have been implanted with Deep Brain Stimulation devices for over 3 months. Participants must be able to consent and fluent in English. Those with other central nervous system diseases, dementia, substance abuse issues, or sensory impairments that affect testing are excluded.Check my eligibility
What is being tested?
The study investigates how Deep Brain Stimulation (DBS) influences brain activity in patients with Parkinson's Disease and Essential Tremor by using EMG and EEG tests. It will compare the effects of different DBS settings while on or off Parkinson's medication and during rest or task performance.See study design
What are the potential side effects?
While this study primarily focuses on measuring brain activity through non-invasive tests like EMG and EEG, potential side effects may relate to changes in DBS settings which can include discomfort, headache, dizziness, or temporary worsening of tremors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during the 8 hour office visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during the 8 hour office visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
characterize and record brain activity

Trial Design

4Treatment groups
Experimental Treatment
Group I: PD with DBS onExperimental Treatment1 Intervention
intervention is EEG while at rest and performing tasks, on anti PD medications and off anti PD medications
Group II: PD with DBS offExperimental Treatment1 Intervention
intervention is EMG while at rest and performing tasks, on anti PD medications and off anti PD medications
Group III: ET with DBS onExperimental Treatment1 Intervention
intervention is EEG while performing tasks and at rest
Group IV: ET with DBS offExperimental Treatment1 Intervention
intervention is EEG while performing tasks and at rest

Find a Location

Who is running the clinical trial?

Farmer FoundationUNKNOWN
1 Previous Clinical Trials
16 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,010 Total Patients Enrolled
2 Trials studying Essential Tremor
66 Patients Enrolled for Essential Tremor
Kenneth BakerStudy DirectorThe Cleveland Clinic

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04361955 — N/A
Essential Tremor Research Study Groups: ET with DBS off, PD with DBS on, ET with DBS on, PD with DBS off
Essential Tremor Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT04361955 — N/A
Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04361955 — N/A

Frequently Asked Questions

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

Are we still looking for patients to join this experiment?

"Yes, you can find evidence of this on clinicaltrials.gov. The study is currently looking for 180 patients from 1 site. The listing was first posted on 1/31/2020 and the most recent update was on 9/29/2022."

Answered by AI

If a patient is below the age of 45, are they still eligible for this trial?

"Eligibility for this specific trial requires that patients are between 40 and 80 years old. In contrast, there are 81 trials for patients under 18 and 918 trials for patients over the age of 65."

Answered by AI

How many total subjects will be taking part in this research project?

"Yes, this information can be found on the website clinicaltrials.gov. The specific trial was originally posted on 1/31/2020 and was last updated on 9/29/2022. They are looking for a total of 180 participants that will be recruited from 1 location."

Answered by AI

Am I able to help out with this clinical trial?

"The ideal candidate for this study is somebody with a history of parkinson's disease, who is between the ages of 40-80. Additionally, this person must have had a deep brain stimulator (STN, GPi, or VIM) implanted for a minimum of 3 months."

Answered by AI

Who else is applying?

What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Modulatory Effects of Deep Brain Stimulation on Cerebral Cortical Activity
2020. "Modulatory Effects of Deep Brain Stimulation on Cerebral Cortical Activity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04361955.
~13 spots leftby Apr 2025
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