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Completed

NCT Number: NCT03753945

Spine MRI in Patients With Deep Brain Stimulation (DBS)

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Behavioral Symptoms Bone Diseases Brain Diseases Central Nervous System Diseases Depression Dyskinesias Dystonia Movement Disorders Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI of the spine

Diagnostic Test

Perform a clinically indicated MRI of the spine in DBS patients

Primary outcomes

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

    Time frame: Immediately after the MRI

    Assess for adverse events as seen on clinical examination

Secondary outcomes

  1. Assessment of Peri-electrode Tissue Changes (MRI)

    Time frame: Immediately after the MRI

    Assess for peri-electrode tissue changes as seen on MRI

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2018
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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