Spine MRI in Patients With Deep Brain Stimulation (DBS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Spine MRI in Patients With Deep Brain Stimulation (DBS)

Conditions
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Parkinson Disease, Dystonia, Depression, Spinal Stenosis, Spinal Diseases

Intervention / Treatment
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* Diagnostic Test: MRI of the spine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age between 18 and 85 years of age Participants must have undergone implantation of DBS electrodes. Participants must be able to understand the purpose of this research and must sign the informed consent form. Participants must understand that the role of this research is demonstrate the safety of spine MRI in patients with DBS. Exclusion criteria Participants who have serious cognitive or psychological impairments and cannot give informed consent. Participants who are unable to effectively or efficiently communicate, for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective cohort study that will enroll patients who have already undergone DBS electrode placement for a variety of disorders including, but not limited to Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain and Alzheimer's disease. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS electrode placement<br>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. | Diagnostic Test: MRI of the spine<br>* Perform a clinically indicated MRI of the spine in DBS patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MRI-related Adverse Events [Safety] | Assess for adverse events as seen on clinical examination | Immediately after the MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Peri-electrode Tissue Changes (MRI) | Assess for peri-electrode tissue changes as seen on MRI | Immediately after the MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep brain stimulation