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NCT Number: NCT03819738

fMRI in Deep Brain Stimulation

With fMRI, we want to understand the mechanisms of brain neuromodulation in (dys)functional brain circuits, to obtain knowledge on involved brain networks in DBS.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Chronic Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

About this study

Deep brain stimulation represents a neurosurgical treatment option for specific refractory neurological and psychiatric disorders. In these patients a specific brain target is stimulated through an electrode with the use of an implantable pulse generator (IPG). In a functional MRI (fMRI) experiment, the investigators intend to perform imaging during stimulation ON and compare brain activations with the stimulation OFF condition. In this way, they aim to elucidate the involved brain network in deep brain stimulation. Since the connectivity of deep brain structures is complex, different activation patterns are expected in-between subjects and conditions. If specific activation patterns during the stimulation ON condition can be related to treatment response, this is of important clinical value. These findings can lead to an optimization of the deep brain target or even to different useful targets for brain stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Deep brain stimulation system implanted

Exclusion criteria

  • Children and pregnant women will be excluded. Failure to follow to protocol is also an exclusion criterion.

Treatment and study plan

fMRI

Diagnostic Test

Functional MRI will be performed in 1 scan, which will take 1.5 h. (scanning time = 30 min)

Other names: DBS

Primary outcomes

  1. Determine the functional networks that are involved in DBS

    Time frame: 5 years

    To determine differences in activations of functional networks between ON and OFF DBS in an fMRI experiment,

  2. To link the involved network to outcome in DBS therapy

    Time frame: 5 years

    To link specific activation patterns during ON-OFF with a clinical value

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Janssen, PhD

CONTACT

[email protected]

016330669

Tom Theys, PhD

CONTACT

[email protected]

016344241

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Functional Magnetic Resonance Imaging in Deep Brain Stimulation

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2019
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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