Long-Term Treatment for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial researches a treatment for Parkinson's disease involving a special device used twice daily to alleviate symptoms. The focus is on determining the long-term safety and effectiveness of this treatment. Individuals who participated in an earlier study with this device and have been diagnosed with Parkinson's, especially those experiencing difficulty with daily tasks like walking or dressing, are suitable candidates. Participants should not alter their Parkinson's medication regimen during the first three months of the trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance daily life for those with Parkinson's.
Do I have to stop taking my current medications for the trial?
You can stay on your current medications for Parkinson's disease, but you shouldn't start any new ones for the first three months of the trial.
What prior data suggests that this time-varying caloric vestibular stimulation treatment is safe for Parkinson's disease?
Research has shown that time-varying caloric vestibular stimulation is generally safe for people with Parkinson's disease. This non-invasive treatment uses temperature changes in the ear to send signals to the brain. Studies have found that patients tolerate it well, can safely use it at home, and experience improvements in both movement and non-movement symptoms of Parkinson's. Some research also highlights its good safety record, with few serious side effects reported. Overall, it appears to be a promising option for managing Parkinson's symptoms.12345
Why are researchers excited about this trial?
Unlike traditional treatments for Parkinson's disease, such as levodopa or dopamine agonists, this study treatment uses time-varying caloric vestibular stimulation (CVS), a novel approach targeting the vestibular system. Researchers are excited about CVS because it has the potential to improve motor and non-motor symptoms by modulating brain activity, offering a non-drug alternative with possibly fewer side effects. Additionally, the passive-active and active-active treatment arms explore different applications of this technique, which could provide valuable insight into optimizing its effectiveness for long-term management of Parkinson's disease.
What evidence suggests that this trial's treatments could be effective for Parkinson's disease?
Research has shown that time-varying caloric vestibular stimulation (tvCVS) may help alleviate Parkinson's disease symptoms. In this trial, participants in the "passive-active" arm will receive active tvCVS treatment, which studies have shown can reduce both movement-related and other symptoms by about 50%. This treatment adjusts brain activity, potentially improving symptoms. It might also enhance blood flow in the brain, which is crucial for managing Parkinson's. Although more research is needed, initial results offer promise for those seeking new treatment options.12346
Are You a Good Fit for This Trial?
This trial is for people who have Parkinson's Disease and were part of the earlier STEM-PD RCT trial. They must be able to consent to participate and commit to attending all study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension Treatment
Participants receive twice daily treatments using a non-invasive brainstem modulation device for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Re-introduction of Treatment
Twice daily treatments are re-introduced for an additional 8 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Open Label Extension Study
Trial Overview
The trial is testing the safety and effectiveness of a treatment given twice daily for Parkinson's symptoms, but only those who completed the prior STEM-PD RCT can join this extension study.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
This group received passive treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE ) trial during which participants received active (i.e., time-varying caloric vestibular stimulation ) treatment.
This group received active (i.e., time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE) trial during which participants received active treatment. Data from participants in this arm was only used for exploratory outcomes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Scion NeuroStim
Lead Sponsor
Citations
Time-varying caloric vestibular stimulation for the treatment ...
Time-varying caloric vestibular stimulation (tvCVS) is a new form of non-invasive neuromodulation similar to, but different from, diagnostic caloric vestibular ...
Caloric vestibular stimulation for the management of motor ...
In a single-case study, daily sessions of caloric vestibular stimulation (CVS) were associated with a ∼50% reduction in both motor and non-motor symptoms of ...
Vestibular Stimulation in Parkinson's Disease
The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease. Detailed Description. Parkinson's ...
4.
michaeljfox.org
michaeljfox.org/grant/using-vestibular-stimulation-improve-neurovascular-status-parkinsons-diseaseUsing Vestibular Stimulation to Improve Neurovascular ...
This study tests the hypothesis that time-varying caloric vestibular stimulation improves symptoms associated with Parkinson's disease by modulating brain ...
5.
frontiersin.org
frontiersin.org/journals/systems-neuroscience/articles/10.3389/fnsys.2021.648928/fullThe Acute Effects of Time-Varying Caloric Vestibular ...
We describe preliminary results from the application of time-varying caloric vestibular stimulation (tvCVS) to volunteers during a continuous BOLD fMRI ...
Caloric and galvanic vestibular stimulation for the treatment ...
The appeal of vestibular stimulation in Parkinson's disease is underpinned by its noninvasive nature, favorable safety profile, and capacity for home-based ...
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