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MRI to Study Deep Brain Stimulation Effects in Neurodegenerative Disease

N/A
Recruiting
Led By Andres Lozano
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be planned to undergo, or have undergone implantation of DBS electrodes
Age between 18 and 85 years of age
Must not have
Participants who have serious cognitive or psychological impairments and cannot give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months before dbs implant to 1 year after dbs implant.
Awards & highlights

Summary

This trial will study the effects of deep brain stimulation (DBS) on the brain using MRI.

Who is the study for?
This trial is for adults aged 18-85 with neurodegenerative diseases who are undergoing or have undergone deep brain stimulation (DBS) electrode implantation. They must understand the study and consent to participate, acknowledging they won't directly benefit from it. Those with serious cognitive impairments or communication issues, such as non-English speakers or those with speech deficits, cannot join.Check my eligibility
What is being tested?
The trial uses advanced MRI technology to perform functional magnetic resonance imaging (fMRI) on patients with DBS implants. The goal is to observe how DBS affects brain function and explore if fMRI can help improve clinical practices for these patients.See study design
What are the potential side effects?
Since this trial involves only MRI scans without any drugs or invasive procedures, there are minimal side effects expected. However, some individuals may experience discomfort from lying still during the scan or anxiety in the enclosed space of the MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for or have had DBS electrode implantation.
Select...
I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and consent to participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months before dbs implant to 1 year after dbs implant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months before dbs implant to 1 year after dbs implant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain areas engaged with deep brain stimulation
Secondary outcome measures
Clinical outcome
Functional connectivity using 1.5T or 3T MRI
Structural connectivity using 1.5T or 3T MRI

Side effects data

From 2017 Phase 2 trial • 17 Patients • NCT01779024
59%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Memory impairment
12%
Hyperhidrosis
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: fMRI-based programmingExperimental Treatment1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Deep Brain Stimulation (DBS) is a common treatment for neurodegenerative diseases like Parkinson's disease, involving electrical stimulation of specific brain circuits such as the subthalamic nucleus (STN) or globus pallidus (GPi). This stimulation modulates abnormal neural activity, improving motor and cognitive functions by restoring more normal patterns of brain activity. DBS can lead to increased neurogenesis and activation of cortical motor circuits, which are crucial for symptom relief and enhancing the quality of life for patients. Understanding these mechanisms helps in developing targeted therapies that address the underlying neural dysfunctions in neurodegenerative diseases.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,492 Previous Clinical Trials
489,794 Total Patients Enrolled
Andres LozanoPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Deep Brain Stimulation (DBS) Clinical Trial Eligibility Overview. Trial Name: NCT03153670 — N/A
Neurodegenerative Disease Research Study Groups: fMRI-based programming
Neurodegenerative Disease Clinical Trial 2023: Deep Brain Stimulation (DBS) Highlights & Side Effects. Trial Name: NCT03153670 — N/A
Deep Brain Stimulation (DBS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03153670 — N/A
Neurodegenerative Disease Patient Testimony for trial: Trial Name: NCT03153670 — N/A
~61 spots leftby Dec 2026