90 Participants Needed

Non-invasive Brain Mapping for Parkinson's Disease

IT
KC
Overseen ByKaty Cross, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different brain activities improve movement in people with Parkinson's disease. Using non-invasive brain mapping techniques like EEG and MRI, researchers hope to identify brain patterns that can aid in developing future treatments, especially for symptoms like freezing of gait. Participants will perform movement tasks while their brain activity is recorded. The trial seeks individuals diagnosed with Parkinson's disease who experience symptoms like tremor or stiffness, as well as healthy adults without neurological conditions. As an unphased trial, participants have the opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these brain mapping techniques are safe for participants?

Research shows that the movement tasks studied for Parkinson's disease are non-invasive, meaning they don't involve surgery or implants. This differs from treatments like deep brain stimulation, which, while generally safe, carry known risks.

Specific safety data for these movement tasks is not yet available. Since the study is in an early phase, researchers are still assessing its safety and effectiveness. Early phases focus on safety, so any serious issues would likely halt the research.

Because the study uses movement tasks, it likely poses less risk than surgical treatments, suggesting fewer side effects or complications. Participants will perform tasks while their brain activity is recorded with EEG (a test that records brain waves) and MRI (a scan that uses magnets and radio waves to create pictures of the brain and body).

Participants in this study will engage in activities to help researchers learn more about the brain, rather than testing a new drug or invasive treatment.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on non-invasive brain mapping for Parkinson's disease. Unlike current treatments that primarily involve medication or surgery to manage symptoms, this approach aims to better understand brain activity and movement patterns in Parkinson's patients. By comparing these patterns with those of healthy individuals, researchers hope to gain insights that could lead to more precise and personalized treatment strategies. This non-invasive method could pave the way for innovative interventions that don't rely on drugs or invasive procedures, potentially improving quality of life for those affected by the disease.

What evidence suggests that this brain mapping technique is effective for improving movement in Parkinson's disease?

Research has shown that understanding brain function can enhance movement in people with Parkinson's disease. Although specific data on movement tasks alone is lacking, studies on deep brain stimulation (DBS) have shown promising results for improving movement problems in Parkinson's patients. DBS has helped many patients move better and reduced their need for medication. These findings suggest that focusing on brain networks can help manage Parkinson's symptoms. This trial will include Parkinson's disease patients and healthy adult controls to identify which brain networks can be influenced to improve movement, potentially leading to new treatments.678910

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's disease, showing at least two main symptoms: tremor, stiffness or slow movement. Healthy adults without neurological diseases can also join. People with dementia, active hallucinations, psychosis or who cannot undergo MRI due to metal implants or claustrophobia are excluded.

Inclusion Criteria

I am older than 18 years.
I am a healthy adult without any brain or nerve diseases.
I have Parkinson's with at least 2 main symptoms or I am healthy with no brain disorders.
See 1 more

Exclusion Criteria

Contraindications to MRI (metal implant, claustrophobia)
You have a score lower than 19 on a test that checks for memory and thinking skills.
I am currently experiencing hallucinations or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Sessions

Participants perform movement tasks during EEG and MRI recording sessions

2 sessions, each lasting about 1.5 hours
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental sessions

up to 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Movement task
Trial Overview The study investigates how certain stimuli facilitate movement in Parkinson's patients by using brain mapping techniques like EEG and MRI during movement tasks. The goal is to understand the brain networks that improve motion which could lead to new treatments.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Parkinson disease patientsExperimental Treatment1 Intervention
Group II: Healthy adultsActive Control1 Intervention

Movement task is already approved in United States for the following indications:

🇺🇸
Approved in United States as DBS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) in patients with advanced Parkinson's disease significantly reduces abnormal brain activity in the motor system, which correlates with improvements in motor symptoms.
Functional brain imaging reveals that DBS not only affects the targeted area but also influences remote brain regions, indicating its complex role in modulating both motor and cognitive functions.
[Functional imaging of deep brain stimulation in idiopathic Parkinson's disease].Hilker, R.[2021]
In a study of 102 participants with active deep brain stimulation (DBS) systems, no short- or long-term adverse events were reported during MRI scans at both 1.5 T and 3 T, indicating that DBS patients can safely undergo MRI procedures.
While DBS hardware caused some imaging artifacts, these only obscured a small portion of the brain (1.4% at 1.5 T and 2.1% at 3 T), primarily affecting areas near the electrode contacts, which suggests that MRI can still provide useful information in these patients.
Functional MRI Safety and Artifacts during Deep Brain Stimulation: Experience in 102 Patients.Boutet, A., Rashid, T., Hancu, I., et al.[2020]
In a study of 319 patients treated with deep brain stimulation (DBS) for various movement disorders over a 10-year period, the procedure demonstrated a favorable safety profile with rare intraoperative adverse events, such as vasovagal response (2.5%) and syncope (1.2%).
Long-term complications were also relatively low, with persistent issues like dysarthria and cognitive dysfunction occurring in about 4% of patients, indicating that DBS is a safe option for treating medically refractory movement disorders.
Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders.Kenney, C., Simpson, R., Hunter, C., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30660117/
Long-term outcomes following deep brain stimulation for ...DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression in PD, ...
UF-led study shows deep brain stimulation benefits for ...For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...
Long-Term Personalized Adaptive Deep Brain Stimulation ...This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.
Chronic adaptive deep brain stimulation for Parkinson's ...General movement improved in five of seven patients, with significant effects in three. Dyskinesia severity decreased in four patients (one ...
Global improvement after deep brain stimulation in ...Among 51 PD patients, CGI rated 21 as “very much improved,” 21 “much improved,” and 9 “minimally improved,” primarily based on MDS-UPDRS III reduction.
The safety issues and hardware-related complications of ...The results showed a 3-year survival rate of 98.6% and a 5-year survival rate of 96.4% for patients with PD who underwent DBS treatment at the study center.
DBS for Parkinson's - Important Safety InformationFind important safety information for treating movement symptoms of Parkinson's disease with deep brain stimulation therapy from Medtronic.
Deep Brain Stimulation for Parkinson's Disease and Other ...Improved motor skills, function, and movement in patients with PD. Safety and effectiveness data adequate to support DBS in patients with PD who have become ...
9.movementdisorders.onlinelibrary.wiley.commovementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29554
Deep Brain Stimulation as an Exclusion Criterion in ...This viewpoint discusses our findings and the potential challenges and solutions for improving access to PD research for DBS patients.
Deep brain stimulation in PD: risk of complications ...However, while DBS has been shown to be a safe and efficacious treatment for PD, even a low rate of complications may present a significant ...
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