Clinical trial NCT03753945: Spine MRI in Patients With Deep Brain Stimulation (DBS)
Official title: Spine MRI in Patients With Deep Brain Stimulation (DBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Dystonia
Depression
Spinal Stenosis
Spinal Diseases
Keywords: deep brain stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of MRI-related Adverse Events [Safety]
timeFrame: Immediately after the MRI
Secondary outcomes:
measure: Assessment of Peri-electrode Tissue Changes (MRI)
timeFrame: Immediately after the MRI
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Andres Lozano
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.