fMRI in Deep Brain Stimulation

Chronic Pain Clinical Trial

Official title:

Functional Magnetic Resonance Imaging in Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819738
• Other study ID #: S60058
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2017
• Est. completion date: January 10, 2022

Study information

• Verified date: November 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Tom Theys, PhD
• Phone: 016344241
• Email: tom.theys[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To link the involved network to outcome in DBS therapy	To link specific activation patterns during ON-OFF with a clinical value	5 years