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Spine MRI in Patients With Deep Brain Stimulation (DBS)

Primary Purpose

Parkinson Disease, Dystonia, Depression

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

MRI of the spine

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring deep brain stimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Toronto Western Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS electrode placement

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of MRI-related Adverse Events [Safety]

Assess for adverse events as seen on clinical examination

Secondary Outcome Measures

Assessment of Peri-electrode Tissue Changes (MRI)

Assess for peri-electrode tissue changes as seen on MRI

Full Information

NCT ID

NCT03753945

First Posted

November 21, 2018

Last Updated

February 8, 2022

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03753945

Brief Title

Spine MRI in Patients With Deep Brain Stimulation (DBS)

Official Title

Spine MRI in Patients With Deep Brain Stimulation (DBS)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

January 21, 2022 (Actual)

Study Completion Date

January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Dystonia, Depression, Spinal Stenosis, Spinal Diseases

Keywords

deep brain stimulation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DBS electrode placement

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI of the spine

Intervention Description

Perform a clinically indicated MRI of the spine in DBS patients

Primary Outcome Measure Information:

Title

Incidence of MRI-related Adverse Events [Safety]

Description

Assess for adverse events as seen on clinical examination

Time Frame

Immediately after the MRI

Secondary Outcome Measure Information:

Title

Assessment of Peri-electrode Tissue Changes (MRI)

Description

Assess for peri-electrode tissue changes as seen on MRI

Time Frame

Immediately after the MRI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andres Lozano

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32059193

Citation

Boutet A, Elias GJB, Gramer R, Neudorfer C, Germann J, Naheed A, Bennett N, Li B, Gwun D, Chow CT, Maciel R, Valencia A, Fasano A, Munhoz RP, Foltz W, Mikulis D, Hancu I, Kalia SK, Hodaie M, Kucharczyk W, Lozano AM. Safety assessment of spine MRI in deep brain stimulation patients. J Neurosurg Spine. 2020 Feb 14:1-11. doi: 10.3171/2019.12.SPINE191241. Online ahead of print.

Results Reference

derived

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Spine MRI in Patients With Deep Brain Stimulation (DBS)

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