RecruitingNot ApplicableNCT06936124

Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease

A Pilot Clinical Trial Investigating Deep Brain Stimulation of the Pedunculopontine Nucleus for the Treatment of Alzheimer's Disease


Sponsor

University Health Network, Toronto

Enrollment

6 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Alzheimer's disease (AD) is a brain disorder that gradually impacts cognitive functions such as memory, thinking, and daily functioning. Gamma oscillations are a type of brain activity thought to play a role in memory and cognition (thinking abilities). In AD, these oscillations are impaired - meaning they are smaller and slower than the brain waves observed in healthy individuals. Research suggests that enhancing these brain waves may help slow the progression of AD. This research is investigating a technique called deep brain stimulation (DBS) of the pedunculopontine nucleus (PPN) as an experimental intervention. An electrode will be implanted in the PPN and deliver mild stimulation over the course of a 12-month period. As a novel intervention, the priority of the study is to determine if DBS-PPN is a safe and feasible intervention for mild-AD. Additionally, the study investigators are evaluating whether DBS-PPN can increase natural gamma oscillations in ways that improve memory and cognition. The insights from this study will guide the design of an accessible larger trial to more definitively assess how effective DBS-PPN could be as a treatment for AD. Participants will: * Undergo a 12-month experimental intervention involving DBS of the PPN. The procedure for implanting the DBS device takes approximately 2-3 hours under general anesthesia, followed by an overnight stay in the hospital for safety monitoring. * Be required to attend regular appointments every 3 months from DBS implantation for the duration of the study. The follow-up visits will include safety and feasibility monitoring, brain scans (EEG and MEG), and cognitive assessments/questionnaires. * Participants' caregiver will also complete questionnaires about their cognition, functioning, and overall health at the follow-up visits.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing deep brain stimulation (DBS) of a specific brain region called the pedunculopontine nucleus (PPN) to treat axial symptoms in Parkinson's disease — problems like freezing of gait (sudden inability to move feet), postural instability (balance problems), and falls that don't respond well to standard Parkinson's medications. **You may be eligible if...** - You have Parkinson's disease with significant gait freezing or balance problems - Your symptoms do not respond adequately to Parkinson's medications - You are a candidate for deep brain stimulation surgery - You are an adult in adequate health for a surgical procedure **You may NOT be eligible if...** - You have severe dementia - You have significant psychiatric illness such as severe depression or psychosis - You have medical conditions that make brain surgery too risky - You have had prior DBS surgery in the same region - You have other causes of gait problems unrelated to Parkinson's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDeep Brain Stimulation of the Pedunculopontine Nucleus

The DBS implantation procedure targeting the PPN involves a neurosurgical operation performed under general anesthesia. During the procedure, thin electrodes are implanted in the PPN with the aid of advanced pre-operative imaging (MRI and CT scan) to confirm precise targeting. This device generates and transmits electrical impulses to the PPN, which can be adjusted to optimize therapeutic outcomes.


Locations(1)

Toronto Western Hospital

Toronto, Ontario, Canada

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NCT06936124


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