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Deep Brain Stimulation for Insomnia (GPS-I Trial)
N/A
Recruiting
Led By Pablo Castillo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Severe insomnia based on ISI score
40-80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights
GPS-I Trial Summary
This trial will test if a brain stimulator can improve insomnia by zapping a different area of the brain.
Who is the study for?
This trial is for people aged 40-80 with Parkinson's Disease who've had symptoms for 7-20 years and suffer from severe insomnia. They shouldn't have dementia, previous brain surgeries like pallidotomy or thalamotomy, be using sleeping pills, or have other major neurological issues. Also, they must be able to visit Jacksonville for follow-ups.Check my eligibility
What is being tested?
The study is testing if activating an extra DBS electrode targeting the globus pallidus externa in the brain can help improve sleep in Parkinson's patients. It involves unilateral deep brain stimulation as a potential treatment for insomnia.See study design
What are the potential side effects?
While not specified here, common side effects of deep brain stimulation may include headache, dizziness, nausea, and possible changes in mood or thinking patterns. There might also be risks associated with surgery such as infection.
GPS-I Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe trouble sleeping.
Select...
I am between 40 and 80 years old.
GPS-I Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Insomnia Severity Index
Secondary outcome measures
Change in Parkinson's Sleep Scale (PDSS)
GPS-I Trial Design
1Treatment groups
Experimental Treatment
Group I: Adults with Parkinson's disease and severe insomniaExperimental Treatment1 Intervention
1 arm study
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,130 Total Patients Enrolled
Pablo Castillo, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville
University De Guayaquil (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe memory and thinking problems.I have severe trouble sleeping.I am between 40 and 80 years old.I have had a previous brain surgery for movement disorders.My Parkinson's disease is caused by another condition.My Parkinson's disease is at an early or very advanced stage.I have been diagnosed with severe sleep apnea.I have trouble sleeping because of pain or an untreated mood disorder.You are currently taking sleep medications.You cannot have an MRI with a magnetic field strength of 3 Tesla.I do not have any major neurological or psychiatric conditions.You have had other implantable devices put in before.I have a disorder affecting my sleep-wake cycle.I have had Parkinson's symptoms for 7 to 20 years.
Research Study Groups:
This trial has the following groups:- Group 1: Adults with Parkinson's disease and severe insomnia
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.
What is the projected sample size of participants for this clinical experiment?
"Affirmative, the clinicaltrials.gov repository shows that this clinical trial is still enrolling participants. The initial posting date was on January 1st 2019 and it has been recently updated on October 31st 2022. This study needs to recruit 10 patients from a single medical centre."
Answered by AI
Are there currently vacancies in this trial for participants?
"According to the clinicaltrials.gov registry, this scientific study is proactively enlisting participants. It was initially advertised on January 1st 2019 and has most recently been revised on October 31st 2022."
Answered by AI
Is this clinical research recruiting participants that are of legal age?
"This clinical trial demands that hopeful volunteers are between 40 and 80 years old. There are 27 studies for minors, while the elderly have 486 trials to choose from."
Answered by AI
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