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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03153670
Other study ID # 14-8255
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date December 1, 2030

Study information

Verified date May 2024
Source University Health Network, Toronto
Contact Alexandre Boutet, MD/MSc
Phone (647) 463-5513
Email alexandre.boutet@mail.utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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: 1. 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). 2. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 1, 2030
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fMRI
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.

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months before DBS implant to 1 year after DBS implant.
Secondary 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 3 months before DBS implant to 1 year after DBS implant.
Secondary 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. 3 months before DBS implant to 1 year after DBS implant.
Secondary Clinical outcome • number of clinic visits required until optimization 3 months before DBS implant to 1 year after DBS implant.
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