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fMRI in Deep Brain Stimulation

NCT ID: NCT03819738

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2025-01-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Epilepsy Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

For each subject, condition effects will be estimated using the general linear model
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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fMRI intervention

Group Type EXPERIMENTAL

fMRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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fMRI

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DBS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Theys, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZLeuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Tom Theys, PhD

Role: CONTACT

[email protected]
016344241

Peter Janssen, PhD

Role: CONTACT

[email protected]
016330669

Other Identifiers

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S60058

Identifier Type: -

Identifier Source: org_study_id

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