What side effects are associated with this type of intervention?

The most common treatments for Parkinson's Disease include dopaminergic therapies such as levodopa and dopamine agonists, cholinesterase inhibitors, and deep brain stimulation (DBS). Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists may lead to edema, somnolence, constipation, dizziness, hallucinations, and nausea. Cholinesterase inhibitors, used for cognitive impairment, can result in worsened tremor, nausea, and vomiting. DBS, an invasive procedure, carries risks of infection, hemorrhage, confusion, and seizures, though severe adverse effects are uncommon and often reversible by adjusting the stimulation.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including pharmacological agents and neuromodulation techniques. Deep Brain Stimulation (DBS) is a notable FDA-approved neuromodulation treatment that involves implanting a device to stimulate specific brain regions, such as the globus pallidus interna or subthalamic nucleus, to alleviate motor symptoms. Pharmacological treatments include levodopa, dopamine agonists, MAO-B inhibitors, and amantadine, which are used to manage symptoms and improve quality of life. While DBS is the primary neuromodulation technique approved, ongoing research continues to explore other methods like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS).

What other types of research exist?

Promising, novel alternatives to Direct Brain Stimulation for Parkinson's Disease patients include: 1) Low Frequency Burst Stimulation, which aims to improve neurocognitive functions in PD patients with existing deep brain stimulators. 2) Transcranial Magnetic Stimulation (TMS), which has shown potential in other neurological conditions and may offer benefits for PD. 3) Vagus Nerve Stimulation (VNS), which has been explored for treatment-resistant depression and may have applications in PD. These alternatives are still under investigation and should be discussed with a healthcare provider.

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Brain Stimulation

Brain Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Darrin Lee, MD PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation

Stable medication regimen for at least 3 months

Must not have

History of epilepsy or seizure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 2, week 3, week 15, week 27

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether changing the way the brain is stimulated can improve thinking and movement in people with Parkinson's Disease who already have a brain stimulator. It compares a new type of stimulation (theta burst) with the usual type (gamma). The goal is to see if different electrical impulses can make a difference in brain function. Theta burst stimulation has shown promise in improving motor behavior and synaptic plasticity in experimental parkinsonism.

Who is the study for?

This trial is for adults over 18 with Parkinson's Disease who already have a deep brain stimulator implanted. They must be on stable medication for at least three months and able to consent and follow the study plan. People with epilepsy, dementia, or major substance abuse history cannot join.

What is being tested?

The study tests if changing how the brain stimulator works can improve thinking skills in Parkinson's patients. It involves two types of stimulation (Theta Burst and Gamma) and checks their effects using cognitive tests and fMRI scans at different times.

What are the potential side effects?

Since this trial adjusts existing brain stimulators, side effects may include discomfort from changes in stimulation, headache, dizziness or temporary worsening of Parkinson’s symptoms during adjustment periods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had deep brain stimulation implants in both sides of my brain.

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My medication has not changed in the last 3 months.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of epilepsy or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 2, week 3, week 15, week 27

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 2, week 3, week 15, week 27

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 3, week 15, week 27 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of executive functioning

Evaluation of motor symptoms

Neuroimaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment2 Interventions

double blinded randomization into baseline stimulation followed by theta burst stimulation

Group II: Group AExperimental Treatment2 Interventions

double-blinded randomization into theta burst stimulation followed by baseline stimulation

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) primarily aim to increase or mimic dopamine, a neurotransmitter that is deficient in PD patients. Levodopa is converted to dopamine in the brain, directly replenishing dopamine levels. Dopamine agonists (e.g., pramipexole, ropinirole) stimulate dopamine receptors, mimicking dopamine's effects. MAO B inhibitors (e.g., rasagiline, selegiline) prevent the breakdown of dopamine, prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects. Deep brain stimulation (DBS) involves implanting electrodes in specific brain regions to modulate neural activity, which can help manage motor symptoms when medications are insufficient. These treatments are crucial as they address the motor deficits and improve the quality of life for PD patients.