NCT03153670 3T MRI in Patients With Deep Brain Stimulation (DBS)
| NCT ID | NCT03153670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Neuro-Degenerative Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2017-06-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2017-06-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Andres Lozano
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT03153670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neuro-Degenerative Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03153670 currently recruiting?
Yes, NCT03153670 is actively recruiting participants. Contact the research team at Neurosurgery.Research@uhn.ca for enrollment information.
Where is the NCT03153670 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT03153670 clinical trial?
NCT03153670 is sponsored by University Health Network, Toronto. The principal investigator is Andres Lozano at University Health Network, Toronto. The trial plans to enroll 250 participants.