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Procedure

Aim 1 - 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) and approximately one week later at standard of care battery placement (under general anesthesia).

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Test whether a novel 16-contact DBS lead elicits spatiotemporally distinct oscillations in subthalamic nucleus versus globus pallidus interna.

Test whether spatial maps of DBS-evoked oscillations predict clinically effective stimulation sites on the 16-contact lead.

Validate the biological origin of brain signals using the Neuromodulation eXperiment Testbed (NEXT) system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aim 1 -Experimental Treatment1 Intervention

Elicit and measure interactions between DBS and target neuronal populations

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,579 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,652 Total Patients Enrolled

Harrison Walker, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

2 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

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

What is the overall count of participants being recruited for this clinical investigation?

"Indeed, as mentioned on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the study was made on January 12th, 2024 and it was last edited on the same day. To complete the trial successfully, a total of 10 patients are required from a single designated site."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, as per the information provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking suitable participants. The study was initially posted on January 12th, 2024 and has been recently updated on the same date. There are openings for a total of 10 participants at a single designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD

Harrison Walker, MD 2024. "Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169852.

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