fMRI in Deep Brain Stimulation

Not Applicable

Recruiting

• Conditions: Chronic Pain; Epilepsy
• Interventions: Diagnostic Test: fMRI

• Registration Number: NCT03819738
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2017-03-24
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fMRI intervention	fMRI	-

Primary Outcome Measures

Name	Time	Method
To link the involved network to outcome in DBS therapy	5 years	To link specific activation patterns during ON-OFF with a clinical value
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,

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium