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Clinical Trials/NCT03819738
NCT03819738RecruitingNot Applicable

Functional Magnetic Resonance Imaging in Deep Brain Stimulation

Universitaire Ziekenhuizen KU Leuven2 sites in 1 country20 target enrollmentStarted: March 24, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
2
Primary Endpoint
Determine the functional networks that are involved in DBS

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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