Actively Recruiting

Age: 18Years +
All Genders
ID05843084

The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-07-25

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 7-Tesla magnetic resonance imaging (7T MRI) brain network analysis to improve deep brain stimulation (DBS) treatment for patients with advanced Parkinson's disease. DBS targets the subthalamic nucleus (STN) to modulate malfunctioning brain networks and improve motor symptoms. Current imaging methods using lower resolution MRIs limit the ability to visualize brain networks effectively, leading to variable treatment benefits. The study aims to see if 7T MRI can better visualize STN connections and electrode placement to enhance motor symptom improvement measured by the Unified Parkinson's Disease Rating Scale (UPDRS-III). This is a prospective observational study using 7T MRI as part of standard care without additional interventions. The 7T MRI will visualize the STN subdivisions and their cortical projections, including motor, associative, and limbic areas. Researchers will analyze the position of DBS electrodes relative to these projections and correlate electrode placement with motor symptom improvements. The study collects data continuously from April 2022 to April 2033 as part of routine clinical follow-up. Participants will undergo 7T MRI scanning, which is non-invasive and involves no pain, with monitoring and safety measures in place. Researchers will assess motor symptoms using UPDRS-III after six months of DBS, along with secondary measures including functional health, quality of life, apathy, treatment satisfaction, operation and hospitalization times, medication changes, side effects, and complications. The study involves minimal risk and uses data already collected in routine care, with ongoing monitoring throughout the study period.

CONDITIONS

Brief Title

The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of idiopathic Parkinson's disease
  • Have undergone deep brain stimulation targeting the subthalamic nucleus
Not Eligible

You will not qualify if you...

  • Adults who are legally incompetent
  • No written informed consent provided

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to several days during baseline period

Participants undergo 7-Tesla MRI brain network analysis to visualize individual subthalamic nucleus (STN) subdivisions and their cortical connections relevant to deep brain stimulation.

1 to 2 visits (in-person) for MRI and computed tomography scans

Long-term Monitoring

Duration - Up to 11 years

Participants are followed over time to correlate DBS electrode placement and 7T MRI network maps with clinical outcomes including motor symptoms and quality of life.

Regular clinical assessments and evaluations over study duration

Trial Site Locations

Total: 1 location

1

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 11015AZ

Actively Recruiting

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Research Team

M

Maarten Bot, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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