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NCT Number: NCT03153670

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location status: Recruiting

Location contact

Alexandre Boutet

CONTACT

[email protected]

(647) 463-5513

About this study

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:

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Brain areas engaged with deep brain stimulation

    Time frame: 3 months before DBS implant to 1 year after DBS implant.

    The primary outcome of interest is safety of 3T structural and functional brain MRI scans in patients with implanted DBS.

Secondary outcomes

  1. Structural connectivity using 1.5T or 3T MRI

    Time frame: 3 months before DBS implant to 1 year after DBS implant.

    • to study volume changes (mm3) associated with DBS therapy in patients with movement disorders, psychiatric illness, epilepsy, and pain
  2. Functional connectivity using 1.5T or 3T MRI

    Time frame: 3 months before DBS implant to 1 year after DBS implant.

    • 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. Clinical outcome

    Time frame: 3 months before DBS implant to 1 year after DBS implant.

    • number of clinic visits required until optimization

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre Boutet, MD/MSc

CONTACT

[email protected]

(647) 463-5513

Tasnuva Hoque, BHA

CONTACT

[email protected]

4166035800 ext. 2797

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2030
First posted
May 15, 2017
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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