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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

PC+S_PFC Trial 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.Check my eligibility
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.See study design
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.

PC+S_PFC Trial 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.

PC+S_PFC Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Computational behavioral paradigms of reward processing
Neurofeedback testing using cortical and subcortical signals

PC+S_PFC 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.

Find a Location

Who is running the clinical trial?

Philip StarrLead Sponsor
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,461 Total Patients Enrolled
Simon J. Little, MBBS, PhDLead Sponsor

Media Library

Activa PC+S Prefrontal (Cortical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03131817 — N/A
Parkinson's Disease Research Study Groups: PD with mood disorder or impulsivity
Parkinson's Disease Clinical Trial 2023: Activa PC+S Prefrontal Highlights & Side Effects. Trial Name: NCT03131817 — N/A
Activa PC+S Prefrontal (Cortical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03131817 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a patient meet to qualify for this trial?

"This trial requires 10 people with behavioural difficulties, aged between 30 and 75, to participate. In addition to the age criteria, applicants must have movement disorder symptoms that are severe enough for deep brain stimulator implantation according to standard medical procedures; treatment-resistant tremor-dominant Parkinson's disease patients with significant functional disability despite optimal medication treatments; or those who exhibit intolerance of their medications accompanied by considerable impairment. Other prerequisites include a BDI score greater than 13, QUIP-A test results pointing towards impulsive behaviour (or clinical impression thereof), VAS scores reflecting at least a 30% change when comparing on/off states in"

Answered by AI

Are there any vacancies left in this research trial?

"This research endeavour, which was initially posted on December 16th 2016 and last modified November 23rd 2022 is not currently looking for volunteers. However, there are 512 other studies that require participants at this moment."

Answered by AI

Are individuals of advanced age being enrolled in this medical experiment?

"This clinical trial welcomes patients aged between 30 and 75 years of age."

Answered by AI
~1 spots leftby Dec 2024