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Spine MRI in DBS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753945
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

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 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Spine MRI in Patients With Deep Brain Stimulation (DBS)
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: MRI of the spine
    Perform a clinically indicated MRI of the spine in DBS patients


Primary Outcome Measures :
  1. Incidence of MRI-related Adverse Events [Safety] [ Time Frame: Immediately after the MRI ]
    Assess for adverse events as seen on clinical examination


Secondary Outcome Measures :
  1. Assessment of Peri-electrode Tissue Changes (MRI) [ Time Frame: Immediately after the MRI ]
    Assess for peri-electrode tissue changes as seen on MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753945


Contacts
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Contact: Alexandre Boutet (416) 603-5801 alexandre.boutet@uhn.ca

Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada
Contact: Alexandre Boutet         
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: Andres M. Lozano, Neurosurgeon, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03753945     History of Changes
Other Study ID Numbers: 18-6176
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andres M. Lozano, University Health Network, Toronto:
deep brain stimulation
Additional relevant MeSH terms:
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Spinal Diseases
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Stenosis
Dystonia
Dyskinesias
Neurologic Manifestations
Signs and Symptoms