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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS electrode placement | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI of the spine | Diagnostic Test | Perform a clinically indicated MRI of the spine in DBS patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MRI-related Adverse Events [Safety] | Assess for adverse events as seen on clinical examination | Immediately after the MRI |
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andres Lozano | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32059193 | Derived | Boutet A, Elias GJB, Gramer R, Neudorfer C, Germann J, Naheed A, Bennett N, Li B, Gwun D, Chow CT, Maciel R, Valencia A, Fasano A, Munhoz RP, Foltz W, Mikulis D, Hancu I, Kalia SK, Hodaie M, Kucharczyk W, Lozano AM. Safety assessment of spine MRI in deep brain stimulation patients. J Neurosurg Spine. 2020 Feb 14;32(6):973-983. doi: 10.3171/2019.12.SPINE191241. Print 2020 Jun 1. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2024 | Jun 3, 2024 | 7 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D004421 | Dystonia |
| D003863 | Depression |
| D013130 | Spinal Stenosis |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |