What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) is a common treatment for neurodegenerative diseases like Parkinson's disease, medically refractory tremor, dystonia, and obsessive-compulsive disorder. Known side effects of DBS include infection, bleeding in the brain, hardware complications, and neuropsychiatric symptoms such as depression and anxiety. Additionally, cognitive impairments and speech difficulties may occur. Other treatments, such as cholinesterase inhibitors used for Parkinson's disease dementia, can cause side effects like worsened tremor, nausea, and vomiting. Memantine, another treatment option, may lead to hallucinations and worsened neuropsychiatric symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for neurodegenerative diseases that involve neuromodulation techniques similar to Deep Brain Stimulation (DBS). DBS itself is an FDA-approved treatment for Parkinson's disease, essential tremor, dystonia, and obsessive-compulsive disorder. It involves the implantation of electrodes in specific brain areas to modulate neural activity. Additionally, Vagus Nerve Stimulation (VNS) is approved for treatment-resistant depression and epilepsy, which also involves electrical stimulation to influence brain function. While these treatments do not involve drugs, they represent significant advancements in the use of electrical stimulation for managing neurodegenerative and psychiatric conditions.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for neurodegenerative disease patients include: 1) Transcranial Direct Current Stimulation (tDCS), which is being explored for improving aphasia and other conditions; 2) Focused Ultrasound Thalamotomy, which has shown efficacy in treating tremor-dominant Parkinson's disease; and 3) Repetitive Transcranial Magnetic Stimulation (rTMS), which is being investigated for its efficacy in treating major depression and other psychiatric disorders associated with neurodegenerative diseases.

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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

No Placebo-Only Group

Summary

This trial studies the effects of a treatment using electrical impulses on patients with various neurological and psychiatric conditions. Researchers will use advanced imaging techniques to understand how this treatment affects brain function and structure. This method has been used for over twenty years to treat movement disorders and is a promising treatment for other conditions.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain areas engaged with deep brain stimulation

Secondary study objectives

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%

Hyperhidrosis

12%

Memory impairment

12%

Dizziness

12%

Nausea

Feeling hot

Flushing

Headache

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Ghrelin

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

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.