Back to resultsfMRI in Deep Brain Stimulation
Primary Purpose
Epilepsy, Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
fMRI
Sponsored by
About this trial
This is an interventional health services research trial for Epilepsy focused on measuring fMRI, epilepsy, pain, electrode, brain, neuromodulation, DBS
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.
Sites / Locations
- UZLeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fMRI intervention
Arm Description
Outcomes
Primary Outcome Measures
Determine the functional networks that are involved in DBS
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
To link specific activation patterns during ON-OFF with a clinical value
Secondary Outcome Measures
Full Information
NCT ID
NCT03819738
First Posted
January 22, 2019
Last Updated
January 25, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03819738
Brief Title
fMRI in Deep Brain Stimulation
Official Title
Functional Magnetic Resonance Imaging in Deep Brain Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
January 10, 2022 (Anticipated)
Study Completion Date
January 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Chronic Pain
Keywords
fMRI, epilepsy, pain, electrode, brain, neuromodulation, DBS
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
For each subject, condition effects will be estimated using the general linear model
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fMRI intervention
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
fMRI
Other Intervention Name(s)
DBS
Intervention Description
Functional MRI will be performed in 1 scan, which will take 1.5 h. (scanning time = 30 min)
Primary Outcome Measure Information:
Title
Determine the functional networks that are involved in DBS
Description
To determine differences in activations of functional networks between ON and OFF DBS in an fMRI experiment,
Time Frame
5 years
Title
To link the involved network to outcome in DBS therapy
Description
To link specific activation patterns during ON-OFF with a clinical value
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Theys, PhD
Phone
016344241
Email
tom.theys@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Janssen, PhD
Phone
016330669
Email
peter.janssen@med.kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Theys, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
fMRI in Deep Brain Stimulation
We'll reach out to this number within 24 hrs