fMRI in Deep Brain Stimulation

Functional Magnetic Resonance Imaging in Deep Brain Stimulation

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03819738

Enrollment

Registered

2019-01-28

Start date

2017-03-24

Completion date

2025-01-10

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Epilepsy

Keywords

fMRI, epilepsy, pain, electrode, brain, neuromodulation, DBS

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTfMRI

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Determine the functional networks that are involved in DBS	5 years	To determine differences in activations of functional networks between ON and OFF DBS in an fMRI experiment,
To link the involved network to outcome in DBS therapy	5 years	To link specific activation patterns during ON-OFF with a clinical value

Countries

Belgium

Contacts

Primary ContactTom Theys, PhD

tom.theys@uzleuven.be016344241

Backup ContactPeter Janssen, PhD

peter.janssen@med.kuleuven.be016330669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026