Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease
Recruiting now · Not applicable
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT06936124
- Run by
- University Health Network, Toronto
- People needed
- 6
- Starts
- 2025-05-01
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2025-05-01
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults over 60 years old.
- Diagnosis of Alzheimer's Disease: Satisfied the diagnostic criteria of the National Institute of Aging - Alzheimer's Association criteria for probable AD.
- Clinical dementia rating scale global score of ≤ 1.
- Not taking an acetylcholinesterase inhibitor and/or memantine, or taking a stable dose for at least six months.
- Fluent in English.
- Caregiver available to participate in the study.
You may not qualify if…
- Pre-existing structural brain abnormalities (e.g., significant white matter disease, tumor, infarction, or intracranial hematoma).
- Other neurologic or psychiatric diagnoses, or medical comorbidities that would preclude patients from undergoing surgery.
- Non-fluent in English (it will be very difficult to conduct standard cognitive tests in English on non-fluent English speakers. In addition, language barrier is significant hurdle in providing standard care with communication and cognition being a main outcome measure).
Where it is running
- Toronto Western Hospital — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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