Spine MRI in Patients With Deep Brain Stimulation (DBS)

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03753945
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 34.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Dystonia; Depression; Spinal Stenosis; Spinal Diseases	Diagnostic Test: MRI of the spine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Spine MRI in Patients With Deep Brain Stimulation (DBS)
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Jan 21, 2022
• Actual Study Completion Date: Jan 21, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: DBS electrode placement Participants in this study will be patients who have already undergone surgery for implantation of DBS electrodes. Patients who have already undergone surgery for implantation of DBS electrodes and patients for whom the treating physicians recommends (based on clinical grounds) a spine MRI (cervical, thoracic or lumbar) shall be recruited for the study.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.

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

Outcome Measures

Primary Outcome Measures

1. Incidence of MRI-related Adverse Events [Safety] [Immediately after the MRI]

   Assess for adverse events as seen on clinical examination

Secondary Outcome Measures

1. Assessment of Peri-electrode Tissue Changes (MRI) [Immediately after the MRI]

   Assess for peri-electrode tissue changes as seen on MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

• Principal Investigator: Andres Lozano, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andres M. Lozano, Neurosurgeon, University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03753945
• Other Study ID Numbers: 18-6176
• First Posted: Nov 27, 2018
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Andres M. Lozano, Neurosurgeon, University Health Network, Toronto: deep brain stimulation
• Additional relevant MeSH terms: Spinal Stenosis; Spinal Diseases; Parkinson Disease; Dystonia

Study Results

No Results Posted as of Feb 9, 2022