Spine MRI in Patients With Deep Brain Stimulation (DBS)

Not Applicable

Completed

• Conditions: Dystonia; Spinal Diseases; Depression; Spinal Stenosis; Parkinson Disease
• Interventions: Diagnostic Test: MRI of the spine

• Registration Number: NCT03753945
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is under strict safety guidelines. Depending on the body part being imaged, the safety may vary.

Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom safety data, we designed a set of MR pulse sequences deemed as safe as possible and the protocol allows acquisition of diagnostic quality MRI images.

Detailed Description

The patients who clinically require a spine MRI will undergo a spine MRI with our designed protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done before and after to ensure no peri-electrode tissue changes.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2019-03-01
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBS electrode placement	MRI of the spine	Participants in this study will be patients who have already undergone surgery for implantation of DBS electrodes. Patients who have already undergone surgery for implantation of DBS electrodes and patients for whom the treating physicians recommends (based on clinical grounds) a spine MRI (cervical, thoracic or lumbar) shall be recruited for the study.This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.

Primary Outcome Measures

Name	Time	Method
Incidence of MRI-related Adverse Events [Safety]	Immediately after the MRI	Assess for adverse events as seen on clinical examination

Secondary Outcome Measures

Name	Time	Method
Assessment of Peri-electrode Tissue Changes (MRI)	Immediately after the MRI	Assess for peri-electrode tissue changes as seen on MRI

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada