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Neurostimulation
Neurostimulation for Parkinson's Disease
N/A
Waitlist Available
Led By Casey Halpern, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery
Age 21 - 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 1-2
Awards & highlights
Study Summary
This trialwill study Parkinson's disease and sleep dysfunction, exploring ways to manipulate brain signals to improve sleep. #PD #Parkinsons #Sleep #DBS #DeepBrainStimulation
Who is the study for?
This trial is for adults aged 21-80 with Parkinson's Disease (PD) who have severe motor symptoms not adequately managed by medication, and are candidates for deep brain stimulation surgery. They must have had PD motor symptoms for at least 4 years, no significant cognitive deficits or depression, and no history of certain medical conditions like seizures or heart disease.Check my eligibility
What is being tested?
The study tests if subthalamic nucleus oscillations can be linked to sleep stages in PD patients and whether adaptive neurostimulation can increase restorative sleep. It uses advanced DBS technology to identify sleep biomarkers and create stimulation patterns that adapt to ongoing sleep-stage changes.See study design
What are the potential side effects?
While the specific side effects are not listed here, typical risks may include those associated with deep brain stimulation such as infection risk at the surgical site, headache, confusion or difficulty concentrating, speech problems, balance issues, and tingling or prickling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain MRI does not show any issues that would prevent surgery.
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I am between 21 and 80 years old.
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My movement symptoms are severe and need surgery despite medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 1-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 1-2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep stage duration and transitions
Secondary outcome measures
Sleep Quality
Trial Design
1Treatment groups
Experimental Treatment
Group I: PD with DBSExperimental Treatment1 Intervention
Patients with Parkinson's Disease who opt for DBS surgery and consent to participate in the sleep study.
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
537 Previous Clinical Trials
1,143,934 Total Patients Enrolled
Stanford UniversityOTHER
2,387 Previous Clinical Trials
17,334,130 Total Patients Enrolled
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,563 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had brain surgery before.I do not have uncontrolled blood pressure, bleeding disorders, seizures, heart disease, or issues with anesthesia.You have a history of using drugs or drinking alcohol excessively.My Parkinson's symptoms improve by at least 30% with medication, or I have significant, treatment-resistant tremor.You have severe, untreated depression.I am currently receiving ECT, rTMS, or diathermy treatments.My Parkinson's symptoms haven't improved with oral medications.I have been diagnosed with Parkinson's disease and have had motor symptoms for at least 4 years.My brain MRI does not show any issues that would prevent surgery.I am between 21 and 80 years old.You have been diagnosed with mild cognitive impairment related to Parkinson's disease based on specific tests of attention, executive function, language, memory, and visuospatial ability.I have Restless Leg Syndrome.My movement symptoms are severe and need surgery despite medication.You don't have major memory problems or severe sadness based on formal testing.
Research Study Groups:
This trial has the following groups:- Group 1: PD with DBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is senior participation being allowed in this clinical experiment?
"This clinical trial has a strict age range that applicants must adhere to, which is 21-80 years old. Meanwhile, separate trials exist for those under the age of 18 (31) and over 65 years old (496)."
Answered by AI
How many participants can the trial feasibly accommodate?
"Affirmative. According to clinicaltrials.gov, this research investigation was first posted on October 21st 2020 and is actively recruiting participants. Currently, the trial needs 20 volunteers from two medical centres for its data collection efforts."
Answered by AI
Is eligibility open to join this medical experiment?
"This trial is recruiting 20 participants with Parkinson's disease, aged between 21 and 80. If you meet these criteria, then you are qualified to join the clinical study."
Answered by AI
Is the opportunity to participate in this experiment available at present?
"Clinicaltrials.gov reveals that this trial is actively seeking participants as of today's date; the initial post was published on October 21st, 2020 and has been recently modified on November 4th, 2022."
Answered by AI
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