Recruiting

MRI

Sponsor:

University Health Network, Toronto

Code:

NCT03153670

Conditions

Neuro-Degenerative Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

fMRI

Study Details

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.

Conditions

Neuro-Degenerative Disease

Study ID

NCT03153670

Start date

Jun 1, 2017

Status verified date

Aug, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: fMRI-based programming

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.

Interventions

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.

Primary outcome measure

  • Brain areas engaged with deep brain stimulation [ Time Frame: 3 months before DBS implant to 1 year after DBS implant. ]

Central Contacts and Locations

Central contacts

Alexandre Boutet, MD/MSc

416 603-5800 Ext 3421Neurosurgery.Research@uhn.ca

Tasnuva Hoque, BHA

4166035800Neurosurgery.Research@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Alyssa Schleifer

416 603-5800 Ext 2797Neurosurgery.Research@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-08-13.