NCT00658125

Deep Brain Stimulation (DBS) for Alzheimer's Disease

Completed NA Last updated 27 September 2019

What this trial tests

NA trial testing Bilateral fornix DBS implantation, in Alzheimer Disease in 6 participants. Completed in 30 June 2010.

Timeline

1 March 2007

Primary endpoint
30 June 2010

30 June 2010

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 March 2007
Primary completion	30 June 2010
Estimated completion	30 June 2010
Sites	1 location across Canada

Drugs / interventions tested

• Bilateral fornix DBS implantation,

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

University Health Network, Toronto

Who can join

Adults 40 to 80, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human.

Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain.

Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Optimal deep brain stimulation sites and networks for stimulation of the fornix in Alzheimer's disease.
   Ríos AS, Oxenford S, Neudorfer C, Butenko K, et al · · 2022 · cited 66× · PMID 36517479 · DOI 10.1038/s41467-022-34510-3
2. A circuit view of deep brain stimulation in Alzheimer's disease and the possible mechanisms.
   Yu D, Yan H, Zhou J, Yang X, et al · · 2019 · cited 34× · PMID 31395077 · DOI 10.1186/s13024-019-0334-4
3. Mapping autonomic, mood and cognitive effects of hypothalamic region deep brain stimulation.
   Neudorfer C, Elias GJB, Jakobs M, Boutet A, et al · · 2021 · cited 24× · PMID 33905474 · DOI 10.1093/brain/awab170
4. Alzheimer's Disease Treatment: The Search for a Breakthrough.
   Reiss AB, Muhieddine D, Jacob B, Mesbah M, et al · · 2023 · cited 20× · PMID 37374288 · DOI 10.3390/medicina59061084
5. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
6. Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.
   Bittlinger M, Müller S. · · 2018 · cited 13× · PMID 29886845 · DOI 10.1186/s12910-018-0275-4
7. Cognitive outcomes of deep brain stimulation depend on age and hippocampal connectivity in Parkinson's and Alzheimer's disease.
   Howard CW, Reich M, Luo L, Pacheco-Barrios N, et al · · 2025 · cited 2× · PMID 40838518 · DOI 10.1002/alz.70498
8. Therapeutic Potential of Experimental Stereotactic Hippocampal Cell Transplant in the Management of Alzheimer's Disease.
   Agavriloaei LM, Iliescu BF, Pintilie RM, Turliuc DM. · · 2025 · cited 1× · PMID 39941562 · DOI 10.3390/jcm14030891