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Clinical Trials/NCT03819738
NCT03819738
Recruiting
N/A

Functional Magnetic Resonance Imaging in Deep Brain Stimulation

Universitaire Ziekenhuizen KU Leuven1 site in 1 country20 target enrollmentMarch 24, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
20
Locations
1
Primary Endpoint
Determine the functional networks that are involved in DBS
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2017
End Date
January 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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,

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 Sites (1)

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