Parkinson DiseaseNCT03753945
Spine MRI in Patients With Deep Brain Stimulation (DBS)
A study testing MRI of the spine in people with Parkinson Disease and Dystonia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease, Dystonia, Depression
- What is being tested?
- MRI of the spine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Dystonia, Depression, Spinal Stenosis, Spinal Diseases
- Being tested
- MRI of the spine
- Keywords
- deep brain stimulation
- Medical subject headings
- Parkinson Disease, Dystonia, Depression, Spinal Stenosis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the spineDiagnostic test
Perform a clinically indicated MRI of the spine in DBS patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MRI of the spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MRI-related Adverse Events [Safety]
Assess for adverse events as seen on clinical examination
Measured: Immediately after the MRI
Secondary outcomes (1)
Assessment of Peri-electrode Tissue Changes (MRI)
Assess for peri-electrode tissue changes as seen on MRI
Measured: Immediately after the MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Mar 2019
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Lozano, University Health Network, Toronto
- Investigators
- Andres Lozano, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753945
- Sponsor's protocol ID
- 18-6176
- Status last verified
- Feb 2022
- First submitted
- 21 Nov 2018
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32059193
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine MRI in Patients With Deep Brain Stimulation (DBS)
- ClinicalTrials.gov ID
- NCT03753945
- Acronym / sponsor ID
- 18-6176
- Conditions
- Parkinson Disease, Dystonia, Depression, Spinal Stenosis, Spinal Diseases
- Keywords
- deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| DBS electrode placement | Experimental | Diagnostic Test: MRI of the spineParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the spinePerform a clinically indicated MRI of the spine in DBS patients | Diagnostic test | DBS electrode placement |
Primary outcome
Incidence of MRI-related Adverse Events [Safety]
Time frame: Immediately after the MRI
Assess for adverse events as seen on clinical examination
1 secondary outcome
Assessment of Peri-electrode Tissue Changes (MRI)
Time frame: Immediately after the MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 32059193Boutet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Lozano principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI of the spine in people with Parkinson Disease and Dystonia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MRI-related Adverse Events [Safety] (time frame: Immediately after the MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.