Depression, Dystonia, Parkinson Disease, Spinal Diseases, Spinal Stenosis
Conditions
Keywords
deep brain stimulation
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.
Interventions
DIAGNOSTIC_TESTMRI of the spine
Perform a clinically indicated MRI of the spine in DBS patients
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MRI-related Adverse Events [Safety] | Immediately after the MRI | Assess for adverse events as seen on clinical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Peri-electrode Tissue Changes (MRI) | Immediately after the MRI | Assess for peri-electrode tissue changes as seen on MRI |
Countries
Canada
Outcome results
None listed