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Neuromodulation Device
Brainstem Stimulation for Parkinson's Disease
N/A
Recruiting
Research Sponsored by Scion NeuroStim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fully vaccinated from COVID-19 (at least 2 weeks from their final dose) with one of the current World Health Organization evaluated vaccines, prior to Screen.
Demonstrates a positive response to oral anti-Parkinsonian medications (i.e. dopamine replacement therapies) and treated with these medications for minimum of three years prior to the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will test a device that may help ease symptoms of Parkinson's disease without surgery.
Who is the study for?
Adults aged 18-85 with Parkinson's disease, responding to medications for at least a year, and able to follow the study plan. They need a partner who can participate, stable medication use during the trial, access to smart devices for data collection, and must be fully vaccinated against COVID-19.Check my eligibility
What is being tested?
The trial is testing a non-invasive brainstem stimulation device's safety and effectiveness in treating Parkinson's symptoms. Participants are randomly assigned to receive either this new treatment or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort at the stimulation site or headaches due to the nature of brainstem stimulation. Other risks could relate to individual responses to non-invasive neuromodulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully vaccinated against COVID-19 with a WHO-approved vaccine.
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I've been on Parkinson's medication for over 3 years and it's working.
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I have been diagnosed with Parkinson's disease.
Select...
I have been taking Parkinson's medication for over a year and it helps.
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I have trouble with daily activities like walking or dressing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score
Secondary outcome measures
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total score (Sum of Parts I, II and III)
Change from baseline in the Clinical Global Impression-Improvement (CGI-I)
+2 moreOther outcome measures
Change from baseline in EncephaLogTM 10 meter Timed Up and Go Test
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test
Change from baseline in EncephaLogTM finger tapping test
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Investigational Treatment 2Experimental Treatment1 Intervention
Investigational treatment mode (stimulation pattern) 2
Group II: Investigational Treatment 1Experimental Treatment1 Intervention
Investigational treatment mode (stimulation pattern) 1
Find a Location
Who is running the clinical trial?
Scion NeuroStimLead Sponsor
13 Previous Clinical Trials
512 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active ear infection or significant ear problems.I use a pump for continuous dopamine medication.I experience several non-movement symptoms due to Parkinson's.I have a neurological condition that might show symptoms similar to Parkinson's disease.I am fully vaccinated against COVID-19 with a WHO-approved vaccine.I've been on Parkinson's medication for over 3 years and it's working.I have had at least one ear infection each year for the last two years.I have ongoing issues from a past surgery that still need medical attention.I have been diagnosed with Parkinson's disease.I am not pregnant and do not plan to become pregnant during the study.I am scheduled for a surgery during the study that needs sedation or pain management.I have not had eye surgery in the last 3 months or ear surgery in the last 6 months.I can keep my Parkinson's disease medication stable during the trial.I often fall down.You work during the night.I am not pregnant and agree to use birth control during the trial.You have a device called a cochlear implant in your ear.I have had ringing in my ears for more than 3 months.I expect to attend all visits and complete all study activities.I have had a heart attack, chest pain, stroke, or a mini-stroke in the last year.I am undergoing deep brain stimulation therapy.I have had a traumatic brain injury with lasting effects.I use a permanent or implanted hearing aid.I am between 18 and 85 years old.I can keep my Parkinson's disease medication stable during the trial.I am willing to discuss my sexual health with the study staff.I had an MRI-guided focused ultrasound treatment in the last year.I use apomorphine for sudden symptoms.I have been taking Parkinson's medication for over a year and it helps.I have trouble with daily activities like walking or dressing.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Treatment 1
- Group 2: Investigational Treatment 2
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.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04797611 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I qualify to participate in this scientific investigation?
"Eligibility to this study necessitates a diagnosis of Parkinson's and being between the ages of 18-85. 218 participants have been selected for inclusion in the trial."
Answered by AI
What outcomes is this research attempting to achieve?
"Scion NeuroStim, the trial sponsor, reported that primary outcome of this clinical experiment will be evaluated over a 3 month time frame. This includes measuring change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score. In addition to this primary measure, secondary outcomes such as Change from baseline in Clinical Global Impression-Improvement (CGI-I), Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part II, and Change from baseline in The International Parkinson"
Answered by AI
What is the current enrollment number for this clinical research project?
"Affirmative, clinicaltrials.gov data makes it evident that this trial is still recruiting. Initially posted on May 19th 2022 and most recently edited November 9th 2022, the study seeks to enrol 218 individuals from 20 different sites."
Answered by AI
In which venues is this scientific experiment being conducted?
"This study is taking place at Booth Gardner Parkinson's Care Center in Kirkland, Washington, University of New mexico in Albuquerque, New Mexico and Cleveland Clinic in Cleveland, Ohio. Additionally there are 20 other participating medical centres."
Answered by AI
Does this trial accept people aged 45 or above?
"This medical study is recruiting patients aged between 18 and 85. There are 30 studies available for younger individuals, while those over 65 have access to 498 trials."
Answered by AI
Are there still slots available to join this investigation?
"According to clinicaltrials.gov this research trial is actively searching for suitable participants. The initial post date was May 19th, 2022 and it has been recently updated on November 9th of the same year."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
University of New Mexico
Meridian Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I am currently taking carbodopa/levodopa three times daily and exercise (walk 2 miles or stationary bicycle 4 miles daily). My symptoms include tremor in my right arm, some dizziness occasionally, and anxiety/restlessness frequently at night. I have also previously had a TIA and so am on blood pressure, blood thinner, cholesterol meds.
PatientReceived no prior treatments
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