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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months before dbs implant to 1 year after dbs implant.

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months before dbs implant to 1 year after dbs implant.

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

Feeling hot

Flushing

Headache

Decreased appetite

100%

80%

60%

40%

20%

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,474 Previous Clinical Trials

484,792 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this research project?

"Affirmative. The clinicaltrial.gov portal indicates that this experiment is presently seeking volunteers, which was originally posted on June 1st 2017 and last updated January 19th 2022. Specifically, the research team requires 250 participants to be enrolled at one site of their choosing."

Answered by AI

Are older adults being embraced by this clinical investigation?

"This trial's inclusion criteria stipulates that participants must be aged 18 or above and no older than 85."

Answered by AI

Who can be admitted to participate in this investigation?

"For this investigation, 250 patients with neurodegenerative conditions aged 18-85 are sought after. Moreover, all participants must be scheduled for or have undergone a deep brain stimulation (DBS) procedure and demonstrate understanding of the research's purpose before signing an informed consent form acknowledging they will not benefit directly from participating in this study."

Answered by AI

Are there any openings still available for prospective participants in this clinical trial?

"The clinical trial's presence on clinicaltrials.gov confirms that it is currently recruiting patients, with the listing having been posted first on June 1st 2017 and updated most recently on January 19th 2022."

Answered by AI