Spine MRI in Patients With Deep Brain Stimulation (DBS)

Depression Clinical Trial

Official title:

Spine MRI in Patients With Deep Brain Stimulation (DBS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753945
• Other study ID #: 18-6176
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Dystonia
• Parkinson Disease
• Spinal Diseases
• Spinal Stenosis

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