Depression Clinical Trial
Official title:
Spine MRI in Patients With Deep Brain Stimulation (DBS)
NCT number | NCT03753945 |
Other study ID # | 18-6176 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | January 21, 2022 |
Verified date | February 2022 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 21, 2022 |
Est. primary completion date | January 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of MRI-related Adverse Events [Safety] | Assess for adverse events as seen on clinical examination | Immediately after the MRI | |
Secondary | 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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