Advanced brain imaging for improving deep brain stimulation in Parkinson's and essential tremor patients
The BRAINMAP-DBS Study
This study is testing if advanced brain imaging can help doctors place and program deep brain stimulation better for people with Parkinson's disease and essential tremor to improve their movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (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 | NCT06932692 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of deep brain stimulation (DBS) for patients with Parkinson's disease and essential tremor by utilizing advanced imaging techniques, specifically 7-Tesla MRI and magnetoencephalography (MEG). The researchers will analyze brain networks to improve electrode placement and programming of DBS, which could lead to better patient-specific treatment outcomes. By focusing on the intricate motor networks within the brain, the study seeks to address the limitations of current DBS methods that rely on lower-resolution imaging. The goal is to achieve more significant motor improvements for patients who currently experience insufficient benefits from DBS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with idiopathic Parkinson's disease or essential tremor who have undergone at least six months of DBS and a preoperative 7-Tesla MRI scan.
Not a fit: Patients with spinal stimulation or DBS systems incompatible with 7-Tesla MRI, or those with non-removable implants that may interfere with MEG, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function in patients with Parkinson's disease and essential tremor who are currently not receiving adequate benefits from existing DBS treatments.
How similar studies have performed: Previous studies utilizing 7-Tesla MRI and MEG for brain network visualization have shown promising results, indicating that this approach is based on established methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Age \> 18 years; * Idiopathic PD/ET with at least six months of DBS * Underwent a preoperative 7-Tesla MRI scan Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Legally incompetent adults; * No written informed consent. * A spinal stimulation or deep brain stimulation system is not compatible with 7-Tesla MRI * There a no implants inadmissible in the MEG, although patients will be questioned for possible (non-removable) implants such as pacemakerand/or dental as they may interfere with the magnetic signals
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Maarten Bot Bot, MD PhD
- Email: m.bot@amsterdamumc.nl
- Phone: 0031621514048
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.