Movement Task Facilitation for Parkinson's Disease

Overseen By Mai Miura, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cognitive disease, Psychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different brain networks assist people with Parkinson's disease in moving better when prompted by external cues, such as sounds or signals. Researchers will examine brain activity during deep brain stimulation (DBS) surgery to identify markers that could lead to new treatments. The goal is to address symptoms like "freezing of gait" that do not improve with current medications. Suitable participants have Parkinson's disease with symptoms like tremors or stiffness and are scheduled for DBS surgery due to persistent movement issues despite treatment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that anticoagulant or antiplatelet therapy should not be used within 1 week before surgery.

What prior data suggests that this method is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease. When doctors carefully select patients, the risk of complications remains low. Some studies suggest that DBS can improve movement issues for up to five years.

DBS was once considered only after other treatments failed, but it is now often used earlier, during the moderate stages of Parkinson's, for better results. While DBS might increase the likelihood of hospital visits, it is overall considered a safe and effective way to manage Parkinson's symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Parkinson's disease, like medications and Deep Brain Stimulation (DBS), focus on managing symptoms rather than improving specific motor tasks. However, the movement task facilitation being studied is unique because it aims to enhance motor skills directly through specific tasks. Researchers are excited about this approach because it could potentially improve the daily functioning and quality of life for patients by targeting the core difficulties they face with movement. This method could complement existing treatments by offering a more tailored and functional approach to managing Parkinson's symptoms.

What evidence suggests that this movement task is effective for Parkinson's disease?

Research has shown that assisting with movement tasks during deep brain stimulation (DBS) for Parkinson's disease can enhance movement. DBS effectively reduces shaking, stiffness, and slow movement. Some studies suggest that customized DBS can aid in walking, though it does not significantly improve balance issues. While DBS does not halt disease progression, it can provide lasting symptom relief. This trial will focus on movement tasks during DBS, potentially offering additional ways to improve mobility for people with Parkinson's disease. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people with advanced Parkinson's disease who are already scheduled for deep brain stimulation surgery. They should be able to cooperate during an awake procedure and have symptoms that improve with L-dopa or have a medication-refractory disabling tremor. Participants must not have cognitive impairments, psychiatric diseases, or medical conditions that rule out surgery.

Inclusion Criteria

I have Parkinson's with symptoms like tremor, stiffness, or slow movement.

I am having deep brain stimulation for Parkinson's with specific symptoms and MRI findings.

Exclusion Criteria

Significant cognitive or psychiatric disease based on clinical neuropsychological testing

I cannot undergo surgery due to medical reasons, including recent use of blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Recording

Participants perform movement tasks during awake DBS surgery with intraoperative recordings of brain signals

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Movement task

Trial Overview The study aims to understand how certain stimuli facilitate movement in Parkinson's patients by recording brain activity during DBS surgery. Patients will perform movement tasks while awake, which could help identify new targets for treating symptoms unresponsive to current therapies.

How Is the Trial Designed?

Group I: Parkinson disease patients Experimental Treatment 1 Intervention

Parkinson disease patients undergoing DBS Surgery of the Globus Pallidus Internus (GPi) for clinical indications

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

Approved in United States as DBS for:

• Parkinson's disease (tremor, advanced symptoms, earlier stages with motor symptoms not adequately controlled with medication)
• Essential tremor
• Multiple sclerosis

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) for Parkinson's disease, particularly targeting the subthalamic nucleus (STN), provides significant motor improvement and allows for reduced medication doses, making it a preferred option for younger patients with motor complications.

While STN DBS has advantages like better motor control and lower current consumption, it requires more intensive postoperative management and carries risks such as infection and hematoma, though the overall benefit-to-risk ratio is considered favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment results: Parkinson's disease. Pollak, P., Fraix, V., Krack, P., et al.[2019]

Deep brain stimulation (DBS) at a therapeutic frequency of 135 Hz significantly alters neuronal activity in the primary motor cortex (M1) of a monkey with Parkinson's disease, leading to improved motor symptoms by changing firing patterns and rates in the pallido-thalamocortical circuit.

Sub-therapeutic DBS (30 Hz) did not enhance motor responses or change discharge rates in M1, indicating that effective symptom relief is linked to specific stimulation parameters that modulate neuronal activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pallidal stimulation that improves parkinsonian motor symptoms also modulates neuronal firing patterns in primary motor cortex in the MPTP-treated monkey. Johnson, MD., Vitek, JL., McIntyre, CC.[2021]

In a study of 40 Parkinson's disease patients undergoing subthalamic deep brain stimulation (STN-DBS), 45% reported significant improvement in sleep quality at 6 months, although this improvement was not statistically significant at 12 months.

The most common benefits included better overall sleep quality and maintenance, but some patients experienced new-onset daytime sleepiness, indicating that while STN-DBS can improve sleep, the effects can vary widely among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. Kharkar, S., Ellenbogen, JR., Samuel, M., et al.[2020]

Deep brain stimulation (DBS) can improve motor function and quality of life in patients with Parkinson's disease when used alongside traditional medication, particularly for those whose symptoms are not well-controlled by medication alone.

However, while DBS offers significant benefits, it also comes with a higher risk of adverse events compared to pharmacotherapy, highlighting the need to carefully consider the risks and benefits before opting for this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. Sharma, A., Szeto, K., Desilets, AR.[2012]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

In a study involving 6 patients with Parkinson's disease, therapeutic deep brain stimulation (DBS) of the subthalamic nucleus normalized brain activation patterns during movement, particularly increasing activity in areas like the supplementary motor area and cerebellum.

Effective DBS not only improved movement execution but also reduced compensatory overactivity in various brain regions, suggesting a more efficient motor control system in patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normalizing motor-related brain activity: subthalamic nucleus stimulation in Parkinson disease. Grafton, ST., Turner, RS., Desmurget, M., et al.[2021]

The study involved 20 patients with Parkinson's disease and 20 healthy controls, using deep brain stimulation to explore how different pathways in the brain affect motor control and cognitive adaptation during movement tasks.

Findings indicate that while deep brain stimulation can modulate motor functions, it does not fully restore cognitive flexibility or kinematic control, suggesting that targeted stimulation strategies could enhance treatment efficacy and reduce side effects in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional segregation of basal ganglia pathways in Parkinson's disease. Neumann, WJ., Schroll, H., de Almeida Marcelino, AL., et al.[2019]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

In a study involving 6 patients with Parkinson's disease (PD) and 6 control subjects, PET scans revealed that while normal subjects showed robust activation in several brain areas during free-choice movement tasks, PD patients exhibited impaired activation in key regions like the putamen and anterior cingulate.

The findings suggest that the impaired activation of medial frontal areas in PD patients may contribute to their difficulties in initiating movements, highlighting the impact of nigral degeneration on cortical function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired mesial frontal and putamen activation in Parkinson's disease: a positron emission tomography study. Playford, ED., Jenkins, IH., Passingham, RE., et al.[2016]

Deep brain stimulation (DBS) is an effective surgical treatment for movement disorders like Parkinson's disease and dystonia, targeting areas such as the subthalamic nucleus (STN) and globus pallidus internus (GPi).

DBS not only improves motor functions but can also affect cognitive and emotional aspects of patients, highlighting the need for careful target selection and consideration of potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical reappraisal of DBS targeting for movement disorders. Guzzi, G., Della Torre, A., Chirchiglia, D., et al.[2017]

In a study involving 12 Parkinson's disease patients and 18 healthy subjects, fMRI revealed that patients exhibited reduced activation in key brain areas (striatum and substantia nigra) during movement initiation, indicating impaired motor control.

During movement inhibition, patients showed decreased activation in the subthalamic nucleus and increased thalamo-cortical activation, suggesting a shift in how their brains process movement control compared to healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral activations related to ballistic, stepwise interrupted and gradually modulated movements in Parkinson patients. Toxopeus, CM., Maurits, NM., Valsan, G., et al.[2021]

In a study involving seven Parkinson's disease patients, continuous deep brain stimulation (DBS) resulted in significantly shorter movement times during wrist tasks compared to a 0.1-second cycling pattern, indicating that stimulation patterns can affect motor performance.

The findings suggest that the effectiveness of DBS may depend on the specific stimulation pattern used, highlighting the importance of optimizing stimulation protocols for better therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of subthalamic nucleus stimulation patterns on motor performance in Parkinson's disease. Montgomery, EB.[2005]

Deep brain stimulation (DBS) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

Deep brain stimulation (DBS) is an established treatment for motor symptoms in advanced Parkinson's disease, but its effects on sleep-wake disturbances (SWD) are not well understood and remain controversial.

The review discusses how DBS may improve SWD not only through direct effects on brain circuits but also indirectly by alleviating nocturnal motor complications and reducing the need for dopaminergic medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Deep Brain Stimulation on Sleep-Wake Disturbances in Patients with Parkinson's Disease: A Narrative Review. Jung, YJ., Kim, HJ., Paek, SH., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.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, it provides durable ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024005837

Effectiveness of Deep Brain Stimulation in Improving ... Current research suggests that DBS results in no significant improvement in balance dysfunction for people with PD.

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.70274

One Side or Two? A Systematic Review of Deep Brain ... Improvement in axial symptoms ranged from 10% to 39% after unilateral stimulation, with less efficiency in unilateral DBS compared to bilateral.

4. nature.com nature.com/articles/s41531-025-00974-5

Will adaptive deep brain stimulation for Parkinson's ... In the next 10 years, aDBS will be clinical routine, but research is needed to define which patients would benefit more from the treatment.

5. ucsf.edu ucsf.edu/news/2025/07/430381/tailored-deep-brain-stimulation-improves-walking-parkinsons

Tailored Deep Brain Stimulation Improves Walking in ... While high-frequency deep brain stimulation (DBS) is highly effective for lessening symptoms of tremors, rigidity, and bradykinesia (the slowing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690827/

Deep brain stimulation in PD: risk of complications ... It is found that, when candidates are carefully screened, DBS is a relatively low-risk procedure, but rate of hospitalization is somewhat increased for DBS ...

7. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... “DBS used to be seen as a last resort, but we now know it provides the most sustained benefit when offered in the moderate stages of Parkinson's ...

8. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838886

Five-Year Outcomes from Deep Brain Stimulation of the ... From screening, a significant improvement in motor outcomes is reported 1 year after deep brain stimulation (DBS) and sustained out to 5 years.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37700176/

Long-term safety and efficacy of frameless subthalamic ... Conclusions: Our data support the use of the frameless system for STN-DBS in PD patients, as a safe and well-tolerated technique, with long-term ...

10. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004670

Deep brain stimulation surgical timing, outcomes, and ... DBS significantly improved motor, mood, and quality-of-life outcomes across all PD durations, with the most substantial benefits observed in mid-duration (5–10 ...