Brain Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Harrison Walker, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Participant has elected to undergo awake DBS surgery as part of routine care, and the subthalamic nucleus (STN) or globus pallidus interna (GPi) are recommended by the multidisciplinary DBS committee as the surgical target.

Stable doses of PD medications for at least 28 days prior to baseline assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at standard of care dbs surgery (awake), approximately one week later at standard of care battery placement (under general anesthesia), at in a research clinical assessment at 16 months after dbs surgery.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find out if new brain stimulation devices can help us identify the most effective spot in the brain for treatment.

Who is the study for?

This trial is for adults over 18 with advanced Parkinson's Disease (PD), showing at least two of three main PD symptoms, and having had the disease for four years or more. Candidates must be planning to undergo awake DBS surgery where either STN or GPi is the target, have a mostly normal brain MRI, can cooperate during surgery/post-op evaluations, and have insurance covering DBS as routine care. They should also have refractory motor symptoms despite treatment.

What is being tested?

The study tests whether new deep brain stimulation (DBS) device technologies can create and record brain rhythms to identify optimal locations for clinical stimulation in treating Parkinson's Disease. It involves using the NEXT system during awake DBS surgeries on patients who've chosen this as part of their standard care.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with DBS may include headache, infection at the implant site, speech problems, balance issues, mood changes or depression. The exact side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

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

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I have chosen awake DBS surgery targeting STN or GPi as recommended.

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My Parkinson's disease medication dose has been stable for at least 28 days.

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My condition has been present for at least 4 years.

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My health insurance or Medicare covers DBS surgery.

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I am over 18 years old.

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I have been diagnosed with advanced Parkinson's disease showing at least two main symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at standard of care dbs surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at standard of care dbs surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).

This trial's timeline: 3 weeks for screening, Varies for treatment, and at standard of care dbs surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Test whether directional DBS leads elicit spatiotemporally distinct oscillations in subthalamic nucleus versus globus pallidus interna.

Test whether spatial maps of DBS-evoked oscillations predict clinically effective stimulation sites on a directional DBS lead.

Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia.