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Cortical Stimulation

Cortical Stimulation for Parkinson's Disease (PC+S_PFC Trial)

N/A

Waitlist Available

Led By Simon Little, PhD

Research Sponsored by Philip Starr

Eligibility Criteria Checklist

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

Must have

UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score

Diagnosis of Parkinson's disease by a movement disorders specialist

Must not have

Any prior intracranial surgery except DBS surgery

Immunocompromised

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether electrical stimulation of the brain can help relieve symptoms of Parkinson's disease.

Who is the study for?

This trial is for Parkinson's disease patients aged 30-75 with severe movement symptoms despite medication, who may benefit from deep brain stimulators. They should have mood or behavioral issues like depression or anxiety and show improvement on medication. Excluded are pregnant women, those with significant cognitive impairment, prior intracranial surgery (other than DBS), major comorbidities, or conditions that could interfere with the study.

What is being tested?

The study tests cortical stimulation using Activa PC+S Prefrontal to alleviate mood and behavioral symptoms in Parkinson's patients. Participants will be selected based on specific criteria including their response to medications and severity of symptoms.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects might include discomfort at the stimulation site, headache, infection risk from surgery, changes in mood or behavior beyond intended effects, and possible interference with other devices.

Eligibility Criteria

Inclusion Criteria

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

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My Parkinson's symptoms improve by at least 30% when I take my medication.

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I have been diagnosed with Parkinson's disease by a specialist.

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My movement disorder is severe enough to need surgery despite medication.

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I am between 30 and 75 years old.

Exclusion Criteria

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

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I have had brain surgery, but not for deep brain stimulation.

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My immune system is weak.

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I need treatments like diathermy, ECT, or TMS for a long-term condition.

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I have a history of seizures.

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I currently have an infection.

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I have a serious health condition like severe high blood pressure or diabetes that could make surgery risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Level of reduction in Anxiety in Parkinson's Disease patients treated with cortical stimulation

Level of reduction in Depression in Parkinson's Disease patients treated with cortical stimulation

Other study objectives

Computational behavioral paradigms of reward processing

Neurofeedback testing using cortical and subcortical signals

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PD with mood disorder or impulsivityExperimental Treatment1 Intervention

This is a single-center study of the neurophysiology of non-motor symptoms such as anxiety, depression, and impulsivity that are comorbid in Parkinson's Disease.

0 / 10Eligibility criteria met