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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2022
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Diagnostic Test:
MRI of the spine
Perform a clinically indicated MRI of the spine in DBS patients

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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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