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Decision Aid for Deep Brain Stimulation in Parkinson's Disease

N/A
Recruiting
Led By Michelle E Fullard, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Atypical Parkinsonism
Diagnosis of Dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months post-deep brain stimulation surgery or 2 months post decision not to undergo surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a Decision Aid can assist patients with Parkinson's disease in deciding whether to undergo Deep Brain Stimulation surgery. They want to know if the Decision Aid is helpful to patients and

Who is the study for?
This trial is for Parkinson's disease patients considering Deep Brain Stimulation surgery. Participants will use a Decision Aid tool and complete surveys over 6 months to see if it helps in their decision-making process.
What is being tested?
The study tests whether a Decision Aid can make it easier for Parkinson's patients to decide on undergoing brain surgery. It compares the effects of receiving this aid early or later during the surgical evaluation.
What are the potential side effects?
Since this trial focuses on a decision-making tool rather than medication, there are no direct medical side effects; however, participants may experience stress or anxiety related to making treatment decisions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with atypical Parkinsonism.
Select...
I have been diagnosed with dementia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months post-deep brain stimulation surgery or 2 months post decision not to undergo surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months post-deep brain stimulation surgery or 2 months post decision not to undergo surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability tool from the Ottawa Hospital Research Institute
Decisional Conflict Scale (DCS)
Secondary study objectives
Decision Quality Worksheet
Decision Readiness Instrument
Decision Self-Efficacy scale
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Decision AidExperimental Treatment1 Intervention
Participants will receive the Decision Aid at baseline.
Group II: Delayed Decision AidActive Control1 Intervention
Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,470 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,803 Previous Clinical Trials
2,822,081 Total Patients Enrolled
Michelle E Fullard, MDPrincipal InvestigatorUniversity of Colorado, Denver
~28 spots leftby Jul 2026