Neuro-Degenerative DiseaseNCT03153670
3T MRI in Patients With Deep Brain Stimulation (DBS)
A study testing fMRI in people with Neuro-Degenerative Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease, medically refractory tremor, dystonia and obsessive compulsive disorder. Several hypotheses driven DBS trials are underway to study modulation of circuit dysfunction in other neurological and psychiatric disorders like epilepsy… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 be planned to undergo, or 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 to enhance our understanding of brain functioning and that he/she will not directly or indirectly benefit from the study.
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. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Alyssa Schleifer, 416 603-5800 Ext 2797, Neurosurgery.Research@uhn.ca
About this study
Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease, medically refractory tremor, dystonia and obsessive compulsive disorder. Several hypotheses driven DBS trials are underway to study modulation of circuit dysfunction in other neurological and psychiatric disorders like epilepsy, Alzheimer's disease and depression. Recent reports suggest profound effects of DBS on the anatomy and function of downstream areas in the brain. For example electrical stimulation of limbic circuits is associated with increase in hippocampal neurogenesis. Similarly, stimulation of subthalamic nucleus (STN) or globus pallidus (GPi) results in activation of cortical motor circuits. Non-invasive imaging modalities are increasingly being employed in these investigations to better understand the effects of DBS on the structure and function of the brain.
There have been important advances in MRI and we now have MRI which provides higher resolution and higher quality brain images. More specifically, the investigators propose to use MRI to perform functional magnetic resonance imaging (i.e. fMRI) to assess the effects of deep brain stimulation on brain function and to assess whether fMRI can be used as an adjunct to improve clinical practice in these patients.
Read the detailed description
This is a prospective cohort study that will enroll patients who are about to or 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 will all undergo DBS to treat specific circuit dysfunctions. Pre-operative DBS patients and patients with externalized leads or internalized IPG may be included.
We propose to study patients with externalized leads or internalized IPG programmed at either 'switched off' (IPG at 0 volt and off state) and 'switched on' settings We have already performed phantom safety testing for these experimental conditions and found it to be safe. We propose to perform the following scans:
- Structural 1.5Tesla or 3Tesla MRI with 8 channel coil/or transmit-receive head coil - 3D FSPGR, standard FRFSE T2 scan, standard DTI scan (white matter tracts) and standard QSM (Quantitative Susceptibility Mapping) scan (Iron quantification).
- Resting state and task based functional MRI with 8 channel coil
Further, we propose to assess whether the aforementioned scans can be used as an adjunct to improve current DBS post-operative follow up.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
DBS patients will undergo fMRI scanning. For each patient, scans will be performed using a selection of DBS settings. fMRI responses will be analysed to evaluate brain responses on different DBS settings. These results will be provided to the programming clinician to guide them choose the optimal setting for each patient at the clinician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| fMRI-based programming | Experimental | DBS patients will undergo fMRI scanning while on different stimulation settings. The results will be fed to the programming clinician (movement disorder neurologist) to aid the conventional programming process at the clinician's discretion. Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain areas engaged with deep brain stimulation
The primary outcome of interest is safety of 3T structural and functional brain MRI scans in patients with implanted DBS.
Measured: 3 months before DBS implant to 1 year after DBS implant.
Secondary outcomes (3)
Structural connectivity using 1.5T or 3T MRI
- to study volume changes (mm3) associated with DBS therapy in patients with movement disorders, psychiatric illness, epilepsy, and pain
Measured: 3 months before DBS implant to 1 year after DBS implant.
Functional connectivity using 1.5T or 3T MRI
- To study the mechanisms underlying the therapeutic effects of DBS as measured by changes in functional and anatomical connectivity of the motor, sensory, memory and cognition circuits.
Measured: 3 months before DBS implant to 1 year after DBS implant.
Clinical outcome
- number of clinic visits required until optimization
Measured: 3 months before DBS implant to 1 year after DBS implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jun 2017
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuro-Degenerative 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
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
- NCT03153670
- Sponsor's protocol ID
- 14-8255
- Status last verified
- Aug 2026
- First submitted
- 10 May 2017
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boutet A, Madhavan R, Elias GJB, Joel SE, Gramer R, Ranjan M, Paramanandam V, Xu D, Germann J, Loh A, Kalia SK, Hodaie M, Li B, Prasad S, Coblentz A, Munhoz RP, Ashe J, Kucharczyk W, Fasano A, Lozano AM. Predicting optimal deep brain stimulation parameters for Parkinson's disease using functional MRI and machine learning. Nat Commun. 2021 May 24;12(1):3043. doi: 10.1038/s41467-021-23311-9.
PubMed 34031407Chow CT, Kashyap S, Santyr B, Yang B, Germann J, Colditz M, Loh A, Matossian G, Varughese S, Owsicki N, Naheed A, Qiu J, Ajala A, Paff M, Graham SJ, Uludag K, Lozano AM, Boutet A. Optimized Brain Functional MRI for Patients With Deep Brain Stimulation Systems. Neurosurgery. 2026 Sep 18. doi: 10.1227/neu.0000000000004217. Online ahead of print.
PubMed 42757837
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3T MRI in Patients With Deep Brain Stimulation (DBS)
- ClinicalTrials.gov ID
- NCT03153670
- Acronym / sponsor ID
- 14-8255
- Conditions
- Neuro-Degenerative Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 15 May 2017 (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.
Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease, medically refractory tremor, dystonia and obsessive compulsive disorder. Several hypotheses driven DBS trials are underway to study modulation of circuit dysfunction in other neurological and psychiatric disorders like epilepsy, Alzheimer's disease and depression. Recent reports suggest profound effects of DBS on the anatomy and function of downstream areas in the brain. For example electrical stimulation of limbic circuits is associated with increase in hippocampal neurogenesis. Similarly, stimulation of subthalamic nucleus (STN) or globus pallidus (GPi) results in activation of cortical motor circuits. Non-invasive imaging modalities are increasingly being employed in these investigations to better understand the effects of DBS on the structure and function of the brain.
There have been important advances in MRI and we now have MRI which provides higher resolution and higher quality brain images. More specifically, the investigators propose to use MRI to perform functional magnetic resonance imaging (i.e. fMRI) to assess the effects of deep brain stimulation on brain function and to assess whether fMRI can be used as an adjunct to improve clinical practice in these patients.
Detailed description
This is a prospective cohort study that will enroll patients who are about to or 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 will all undergo DBS to treat specific circuit dysfunctions. Pre-operative DBS patients and patients with externalized leads or internalized IPG may be included.
We propose to study patients with externalized leads or internalized IPG programmed at either 'switched off' (IPG at 0 volt and off state) and 'switched on' settings We have already performed phantom safety testing for these experimental conditions and found it to be safe. We propose to perform the following scans:
- Structural 1.5Tesla or 3Tesla MRI with 8 channel coil/or transmit-receive head coil - 3D FSPGR, standard FRFSE T2 scan, standard DTI scan (white matter tracts) and standard QSM (Quantitative Susceptibility Mapping) scan (Iron quantification).
- Resting state and task based functional MRI with 8 channel coil
Further, we propose to assess whether the aforementioned scans can be used as an adjunct to improve current DBS post-operative follow up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI-based programming | Experimental | Other: fMRIDBS patients will undergo fMRI scanning while on different stimulation settings. The results will be fed to the programming clinician (movement disorder neurologist) to aid the conventional programming process at the clinician's discretion. |
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 be planned to undergo, or 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 to enhance our understanding of brain functioning and that he/she will not directly or indirectly benefit from the study.
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 |
|---|---|---|
| fMRIDBS patients will undergo fMRI scanning. For each patient, scans will be performed using a selection of DBS settings. fMRI responses will be analysed to evaluate brain responses on different DBS settings. These results will be provided to the programming clinician to guide them choose the optimal setting for each patient at the clinician's discretion. | Other | fMRI-based programming |
Primary outcome
Brain areas engaged with deep brain stimulation
Time frame: 3 months before DBS implant to 1 year after DBS implant.
The primary outcome of interest is safety of 3T structural and functional brain MRI scans in patients with implanted DBS.
3 secondary outcomes
Structural connectivity using 1.5T or 3T MRI
Time frame: 3 months before DBS implant to 1 year after DBS implant.
Functional connectivity using 1.5T or 3T MRI
Time frame: 3 months before DBS implant to 1 year after DBS implant.
Clinical outcome
Time frame: 3 months before DBS implant to 1 year after DBS implant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 34031407Boutet A, Madhavan R, Elias GJB, Joel SE, Gramer R, Ranjan M, Paramanandam V, Xu D, Germann J, Loh A, Kalia SK, Hodaie M, Li B, Prasad S, Coblentz A, Munhoz RP, Ashe J, Kucharczyk W, Fasano A, Lozano AM. Predicting optimal deep brain stimulation parameters for Parkinson's disease using functional MRI and machine learning. Nat Commun. 2021 May 24;12(1):3043. doi: 10.1038/s41467-021-23311-9.
- Derived from this study: PubMed 42757837Chow CT, Kashyap S, Santyr B, Yang B, Germann J, Colditz M, Loh A, Matossian G, Varughese S, Owsicki N, Naheed A, Qiu J, Ajala A, Paff M, Graham SJ, Uludag K, Lozano AM, Boutet A. Optimized Brain Functional MRI for Patients With Deep Brain Stimulation Systems. Neurosurgery. 2026 Sep 18. doi: 10.1227/neu.0000000000004217. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
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 fMRI in people with Neuro-Degenerative Disease, 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Boutet, MD/MSc (416 603-5800 Ext 3421, Neurosurgery.Research@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain areas engaged with deep brain stimulation (time frame: 3 months before DBS implant to 1 year after DBS implant.). 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 NCT03153670, which also lists 2 linked publications.
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 13 Aug 2026.