Spine MRI in Patients With Deep Brain Stimulation (DBS)

NCT03753945 | Completed FDA Device

• 1 other identifier: 18-6176
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Dystonia; Depression; Spinal Stenosis; Spinal Diseases

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Incidence of MRI-related Adverse Events [Safety]

  Assess for adverse events as seen on clinical examination

  Immediately after the MRI

Secondary Outcomes (1)

• Assessment of Peri-electrode Tissue Changes (MRI)

  Immediately after the MRI

Study Arms (1)

DBS electrode placement

EXPERIMENTAL

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

Interventions

MRI of the spine DIAGNOSTIC_TEST

Perform a clinically indicated MRI of the spine in DBS patients

DBS electrode placement

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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;32(6):973-983. doi: 10.3171/2019.12.SPINE191241. Print 2020 Jun 1.

  PMID: 32059193 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dystonia; Depression; Spinal Stenosis; Spinal Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Andres Lozano

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: March 1, 2019
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

CA (1)