Comparing imaging-based and threshold assessment-based programming for DBS in Parkinson's disease
Randomized Controlled Trial Comparing Imaging-based Programming With Threshold-assessment Based Programming of Deep Brain Stimulation for Parkinson's Disease
This study is testing whether a new way of programming Deep Brain Stimulation can help people with Parkinson's disease manage their motor symptoms better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06223399 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different programming methods for Deep Brain Stimulation (DBS) in patients with Parkinson's disease experiencing motor fluctuations. Participants will be randomly assigned to receive either imaging-based programming or the standard threshold assessment-based programming. The primary outcome will focus on improvements in motor symptoms during the OFF-drug phase at six months, while secondary outcomes will assess physical disability and quality of life. The study is designed to determine if the imaging-based approach is at least as effective as the traditional method.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Parkinson's disease who are scheduled for DBS screening and can understand the Dutch language.
Not a fit: Patients who may not benefit include those with dementia, current depression or psychosis, or those who have previously undergone functional stereotactic neurosurgery.
Why it matters
Potential benefit: If successful, this study could lead to more efficient and personalized DBS programming, improving motor symptoms and quality of life for patients with Parkinson's disease.
How similar studies have performed: While the approach of using imaging for DBS programming is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parkinson's disease diagnosis based on the clinical diagnostic criteria of Movement Disorder Society * Scheduled for DBS screening * Age of 18 years or older * Understand the Dutch language Exclusion Criteria: * Legally incompetent adults * No written informed consent * Previous functional stereotactic neurosurgery * Dementia * Current depression or psychosis
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Rob de Bie, Prof — Amsterdam UMC
- Study coordinator: Annabel van der Weide, MA
- Email: a.vanderweide@amsterdamumc.nl
- Phone: +31-20-5663943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.