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Deep Brain Stimulation for Parkinson's Disease

CH
Overseen ByChristopher Hurt, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Disqualifiers: Uncontrolled hypertension, Heart disease, Coagulopathy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this pilot study is to assess changes in thinking and movement after deep brain stimulator implantation. The study will also examine whether these changes are related to the risk of falls.

Are You a Good Fit for This Trial?

This trial is for people aged 30-80 with Parkinson's disease who have chosen to get deep brain stimulation (DBS) surgery because their symptoms aren't controlled by medication. Participants must be able to walk and be cleared for DBS surgery, and available for follow-up.

Inclusion Criteria

I am between 30 and 80 years old.
I have chosen to have DBS surgery as part of my regular treatment.
I have been approved for deep brain stimulation surgery by my care team.
See 3 more

Exclusion Criteria

Patient's insurance will not cover the costs of surgery with investigational devices
I do not have a clear response to levodopa medication.
I need a walker or wheelchair to move around.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Observation

Participants are observed prior to DBS surgery to collect baseline data on falls and step count

4-5 months

Post-Surgery Observation

Participants are observed after DBS surgery to assess changes in thinking, movement, and fall risk

4-5 months

Follow-up

Participants are monitored for safety and effectiveness after the observation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deep Brain Stimulation (DBS)

Trial Overview

The study looks at how thinking and movement change after DBS surgery in people with Parkinson's disease, and whether these changes affect the risk of falling. All participants receive DBS as part of standard care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DBS for standard of careExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

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