Neuro-Degenerative Disease Clinical Trial
Official title:
3T MRI in Patients With Deep Brain Stimulation (DBS)
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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
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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