NCT03819738

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

7.8 years

First QC Date

January 22, 2019

Last Update Submit

July 2, 2024

Conditions

EpilepsyChronic Pain

Keywords

fMRIepilepsypainelectrodebrainneuromodulationDBS

Outcome Measures

Primary Outcomes (2)

  • 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,

    5 years

  • To link the involved network to outcome in DBS therapy

    To link specific activation patterns during ON-OFF with a clinical value

    5 years

Study Arms (1)

fMRI intervention

EXPERIMENTAL
Diagnostic Test: fMRI

Interventions

fMRIDIAGNOSTIC_TEST

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

Also known as: DBS
fMRI intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deep brain stimulation system implanted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

EpilepsyChronic PainPain

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tom Theys, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Theys, PhD

CONTACT

016344241tom.theys@uzleuven.be

Peter Janssen, PhD

CONTACT

016330669peter.janssen@med.kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: For each subject, condition effects will be estimated using the general linear model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 28, 2019

Study Start

March 24, 2017

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)