Medications and Deep Brain Stimulation for Movement Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how certain brain areas contribute to movement disorders such as Parkinson's disease, essential tremor, dystonia, and ataxia. Researchers will study the brain's electrical activity using noninvasive electrodes or deep brain stimulators to identify patterns linked to these disorders. Participants will have their brain activity recorded while taking their usual medications, and those with stimulators may have them adjusted during the study. The trial seeks individuals diagnosed with movement disorders, excluding those with dementia. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to improved understanding and treatment of movement disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this study's methods are safe for participants?

Research has shown that deep brain stimulation (DBS) is generally safe for individuals with movement disorders such as Parkinson's disease and essential tremor. One study found that DBS targeting the thalamus (a part of the brain) effectively controlled tremors for at least six years, demonstrating that the treatment works well and is tolerated over time. Another study reported significant improvements in symptoms and quality of life for up to a year after treatment.

However, it is important to understand that while DBS can help with symptoms, it does not halt the progression of diseases like Parkinson's. Some individuals may experience side effects, but these are usually manageable. The treatment involves electrical stimulation and may require adjustments to find the optimal settings for each person. Overall, DBS has a strong record of safely improving symptoms for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how medications and deep brain stimulation (DBS) interact with the brain's circuitry in people with movement disorders. Unlike current treatments that primarily focus on symptom management, this study delves into the neurophysiology of the basal ganglia, thalamus, and cerebellum. By using multimodal neurophysiology techniques, like electroencephalography and electromyography, researchers aim to understand the distinct brain activities associated with medication and DBS adjustments. This could pave the way for more personalized and effective treatment strategies, potentially enhancing the quality of life for individuals with movement disorders.

What evidence suggests that this trial's treatments could be effective for movement disorders?

This trial will compare participants with and without Deep Brain Stimulators (DBS). Studies have shown that DBS can significantly benefit individuals with movement disorders like Parkinson's disease. Research indicates that people using DBS experience a 53% improvement in movement abilities over two years, compared to just a 4% improvement with medication alone. DBS alters the abnormal brain activity causing symptoms. It has improved movement, reduced medication needs, and enhanced quality of life. Specifically, individuals with DBS have experienced up to a 75% improvement in certain symptoms on one side of the body. This evidence supports the potential effectiveness of DBS in improving symptoms of movement disorders. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with movement disorders like Parkinson's disease, essential tremor, dystonia, or ataxia. Participants may have a deep brain stimulation (DBS) device implanted. The study aims to understand the electrical activity in certain brain areas related to these conditions.

Inclusion Criteria

I have been diagnosed with a movement disorder like Parkinson's or essential tremor.

Exclusion Criteria

Patients with dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurophysiology Assessment

Multimodal neurophysiology measurements, such as electroencephalography and electromyography, are conducted during medication administration and DBS adjustment sessions.

Varies per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after neurophysiology assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurophysiology of the Basal Ganglia, Thalamus, and Cerebellum

Trial Overview The study investigates how parts of the brain involved in controlling movement function in people with movement disorders. It involves recording brain activity using scalp electrodes and possibly through an existing DBS device if it can record such activity.

How Is the Trial Designed?

Group I: Participants without Deep Brain Stimulators Experimental Treatment 1 Intervention

Multimodal neurophysiology (for example, electroencephalography and electromyography) will be measured during the following: Movement disorder medication administration -The patient's movement disorders medications, prescribed by their treating physicians outside of this study, may be administered during an experimental session.

Group II: Participants with Deep Brain Stimulators Experimental Treatment 2 Interventions

Multimodal neurophysiology (for example, electroencephalography and electromyography) will be measured during the following: Movement disorder medication administration -The patient's movement disorders medications, prescribed by their treating physicians outside of this study, may be administered during an experimental session. Deep brain stimulator (DBS) adjustment - Participants who have had deep brain stimulation implantation as part of their standard-of-care clinical treatment may participate in this study. The patient's stimulator may be adjusted within normal clinical limits during an experimental session.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) is a reversible and adjustable treatment that has largely replaced traditional ablation procedures for movement disorders, showing therapeutic effects by modulating deep brain nuclei.

The most common targets for DBS include the subthalamic nucleus for advanced Parkinson's disease, the ventral intermediate nucleus of the thalamus for essential tremor, and the globus pallidus interna for dystonias, with varying clinical outcomes based on the target and stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of movement disorders by deep brain stimulation. Yu, H., Neimat, JS.[2022]

Deep brain stimulation (DBS) has been effective in reducing severe tremors in Parkinson's disease, with an 85% success rate when targeting the thalamus, although it has limited impact on other symptoms.

Stimulation of the subthalamic nucleus (STN) significantly decreases motor fluctuations and allows for reduced medication dosages, which helps lower dyskinesias, while globus pallidus internus (GPi) stimulation primarily reduces dyskinesias but shows variable effects on other motor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thalamic, subthalamic nucleus and internal pallidum stimulation in Parkinson's disease. Limousin-Dowsey, P., Pollak, P., Van Blercom, N., et al.[2019]

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]

Unilateral deep brain stimulation (DBS) of the thalamus significantly improved tremor scores in patients with Parkinson's disease over a long-term follow-up period averaging 40 months, demonstrating its efficacy for treating medication-resistant tremor.

While there were some mild adverse effects, including two asymptomatic intracerebral hemorrhages, the overall safety profile was acceptable, with manageable stimulus-related reactions and necessary device replacements due to normal wear and tear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term safety and efficacy of unilateral deep brain stimulation of the thalamus for parkinsonian tremor. Lyons, KE., Koller, WC., Wilkinson, SB., et al.[2019]

Citations

1. ohsu.edu ohsu.edu/brain-institute/dbs-outcomes

DBS Outcomes | Brain Institute Improved movement: One study found that patient motor scores improved 53% after two years with DBS, compared to improving 4% among patients taking medicine.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30660117/

Long-term outcomes following deep brain stimulation for ... Conclusions: DBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression ...

3. 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 ... For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005767

Mechanisms of Deep Brain Stimulation in Movement ... Effective DBS overrides pathological bursts, low frequency oscillations, synchronization, and disrupted firing patterns present in movement disorders.

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

One Side or Two? A Systematic Review of Deep Brain ... Unilateral DBS led to a 48% to 75% improvement in contralateral symptoms and a 15% to 28% improvement in ipsilateral symptoms. Improvement in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3382386/

Deep Brain Stimulation for Parkinson's Disease and Other ... There is Level 3a evidence that DBS of the thalamus is effective in the control of tremor in patients with essential tremor and PD for at least 6 years. There ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000208628

Real-world Clinical Outcomes from a Prospective ... Results from this registry demonstrate significant improvement in ET related symptoms and quality-of-life up to 12-month follow-up.

8. thejns.org thejns.org/view/journals/j-neurosurg/132/1/article-p205.xml

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 ...

9. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/04000/deep_brain_stimulation__dbs__in_movement_disorders.48.aspx

Deep brain stimulation (DBS) in movement disorders... Conclusion: DBS demonstrates efficacy in improving motor symptoms, disease severity, tremor, gait, and tic severity in movement disorders.