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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The research study is being conducted to better understand parts of the human brain called the cortex, basal ganglia, thalamus, and cerebellum in patients with movement disorders (such as Parkinson's disease, essential tremor, dystonia, or ataxia). These brain structures are involved in movement disorders. This study attempts to better understand the brain electrical activity associated with these disorders, both in patients with and without deep brain stimulation (DBS). Recordings are made from the scalp with a noninvasive electrode and/or through the DBS stimulator if the participant has a stimulator model that is able to sense brain activity. These recordings are analyzed along with measures of movement disorder symptoms to identify brain signal signatures of symptoms.

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 data supports the effectiveness of the treatment for movement disorders?

Research shows that deep brain stimulation (DBS) in areas like the subthalamic nucleus and globus pallidus can improve symptoms in conditions like Parkinson's disease and essential tremor by altering brain activity patterns. This suggests that DBS can be an effective treatment for movement disorders by modulating brain circuits involved in movement control. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for treating movement disorders?

Deep brain stimulation (DBS) has been used for various movement disorders like Parkinson's disease and essential tremor with generally low risk. Some patients may experience mild side effects, such as changes in mood or cognition, and rare complications like bleeding in the brain, but these are often manageable. ^{5 6 7 8 9}

How does deep brain stimulation differ from other treatments for movement disorders?

Deep brain stimulation (DBS) is unique because it involves implanting electrodes in specific brain areas to modulate neurological function, offering a reversible and adjustable alternative to traditional surgical procedures. Unlike medications, DBS directly targets brain regions responsible for movement disorders, providing relief from symptoms like tremors and motor fluctuations with fewer complications. ^{2 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Alterations in neuronal activity in basal ganglia-thalamocortical circuits in the parkinsonian state. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The treatment of movement disorders by deep brain stimulation. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Pathophysiology of parkinsonism. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Toward sophisticated basal ganglia neuromodulation: Review on basal ganglia deep brain stimulation. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

External pallidal stimulation improves parkinsonian motor signs and modulates neuronal activity throughout the basal ganglia thalamic network. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Long term safety and efficacy of unilateral deep brain stimulation of the thalamus for parkinsonian tremor. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Humanized Clinically Calibrated Quantitative Systems Pharmacology Model for Hypokinetic Motor Symptoms in Parkinson's Disease. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Frequency-specific effects of stimulation of the subthalamic area in treated Parkinson's disease patients. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Lessons learned in deep brain stimulation for movement and neuropsychiatric disorders. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Thalamic, subthalamic nucleus and internal pallidum stimulation in Parkinson's disease. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor. [2022]