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Study identifier: NCT05843084 Synced from ClinicalTrials.gov · July 29, 2026
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The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation

Condition: Parkinson Disease · Diffusion Magnetic Resonance Imaging · Brain  ·  Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

PhaseN/A
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized. Objective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: The study will be a single center prospective observational study. Study population: Enrollment will be ongoing from April 2022. Intervention (if applicable): No interventi…

This description comes directly from the study's public registry record.

Talk to the study team

Maarten Bot, MD PhD  ·  0031621514048  ·  m.bot@amsterdamumc.nl

Always discuss trial participation with your own doctor first.

Locations (1)

Amsterdam UMC, location AMCAmsterdam, North Holland, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT05843084