3T MRI in Patients With Deep Brain Stimulation (DBS)

NCT03153670 | Recruiting

• 1 other identifier: 14-8255
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Structural connectivity using 1.5T or 3T MRI

  3 months before DBS implant to 1 year after DBS implant.

• Functional connectivity using 1.5T or 3T MRI

  3 months before DBS implant to 1 year after DBS implant.

• Clinical outcome

  3 months before DBS implant to 1 year after DBS implant.

Study Arms (1)

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.

Other: fMRI

Interventions

fMRI OTHER

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.

fMRI-based programming

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

Related 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.

  PMID: 34031407 BACKGROUND

Study Officials

• Andres Lozano

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Boutet, MD/MSc

CONTACT

(647) 463-5513; alexandre.boutet@mail.utoronto.ca

Tasnuva Hoque, BHA

CONTACT

4166035800; tasnuva.hoque@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 15, 2017
• Study Start: June 1, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)