Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
80 participants
INTERVENTIONAL
2025-06-15
2030-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Making Memory Better for Seniors With Mild Cognitive Impairment
NCT01532739
Effects of Cognitive Intervention for Older Adults With Memory Decline: A Pilot Study
NCT00609427
Efficacy, Transfer, and Neuro-functional Basis of a Memory Training Targeting Episodic Retrieval in Older Adults.
NCT06110234
Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment
NCT01448148
Memory Encoding Strategies for People With Mild Cognitive Impairments
NCT02953964
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Studies have demonstrated increased grey matter in the HPC of both young and older human adults as a function of memory training. Interestingly, the HPC shows signs of neurogenesis across the entire lifespan and, in adult primates, this HPC neurogenesis can be stimulated through learning and memory programs that increase HPC cellular survival. Similar training programs may thus enhance HPC cellular survival in Mild Cognitive Impairment (MCI) patients by focusing on the region where the pathology first emerges. While several memory intervention studies have shown success in alleviating memory impairments in participants with subjective cognitive impairment, MCI, and in patients with Alzheimer's disease by presumably affecting the HPC, this has not yet been supported by brain imaging or assessment. By contrast, using virtual reality-based tools, the investigators have developed an innovative learning and memory program. In previous research with healthy older adults, the investigators have shown that spatial memory intervention program (SMIP) improves cognition and hippocampal-based spatial memory compared to controls. In addition, the investigators have shown a positive impact of such training on HPC grey matter. These grey matter changes in the HPC were beneficial to healthy cognition as they correlated to improvements in memory.
In the current study, the investigators propose a randomized controlled trial comparing the effects of a 12-week spatial memory intervention to an active control condition. The design will be stratified according to age, education, and sex. After an eligibility assessment at baseline, participants meeting inclusion criteria will be randomly allocated to one of the two groups with a 50% probability of being enrolled in either a spatial memory intervention or an active placebo condition. In addition, participants will be given a pre-training psychometric battery, which will be repeated twice during two post-training sessions (at one- and 26 weeks post-training) to assess cognition, daily functioning, stress, health, physical activity, quality of life, and self-esteem. The battery will also include independent computerized spatial memory tests assessing the generalization of cognitive improvement in the spatial domain, as well as paper and pencil memory tests described below.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SMIP
Spatial Memory Intervention Program
SMIP
Participants will undergo a 3-month-long regimen of 60 minutes spatial memory training sessions held twice a week, consisting of a series of computerized virtual reality tasks.
Control
The control group will receive no intervention between baseline and follow-up.
No intervention
Control participants will not receive spatial memory intervention training. They will watch documentaries and then complete multiple choice quizzes on its content to ensure they are paying attention. The placebo condition will match the experimental condition in terms of duration and visit frequency.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SMIP
Participants will undergo a 3-month-long regimen of 60 minutes spatial memory training sessions held twice a week, consisting of a series of computerized virtual reality tasks.
No intervention
Control participants will not receive spatial memory intervention training. They will watch documentaries and then complete multiple choice quizzes on its content to ensure they are paying attention. The placebo condition will match the experimental condition in terms of duration and visit frequency.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Primary language is English or French.
3. Individuals having received a diagnosis of Mild Cognitive Impairment (MCI).
Exclusion Criteria
Current post-traumatic stress disorder and/or generalized anxiety disorder; Substance use disorder; Significant heart disease (i.e., stroke occurring during 5 years prior to study assessment or cardiac disease non-stabilized with medication); Severe Depression, or a Geriatric Depression Scale (GDS) score greater than 12; Current insomnia disorder.
2. Current medications for sleep problems, or use of medications that affect sleep.
3. Use of antidepressant and anti-anxiety medication for less than 3 months prior to study entry.
4. Use of analgesics with codeine (or other opioids).
5. Use of antipsychotic medication (past or current).
6. Having undergone brain surgery or ECT.
7. Self-reported colour-blindness.
8. General anesthesia in the past year.
9. Current smoker.
10. Suspected or confirmed traumatic brain injury during the last 24 months.
11. Motion sickness or intolerant to virtual reality tasks.
12. Cholesterol or hypertension medication for less than 3 months or changes expected within the next 9 months.
13. History or presence of neurological or psychiatric disorders (other than MCI) that in the opinion of the investigator may compromise patient safety or study objectives.
14. Current severe medical conditions (e.g. untreated diabetes, cancer) that in the opinion of the investigator may compromise patient safety or study objectives.
15. For female participants, severe menopausal symptoms, including hot flashes (determined from the Greene climacteric scale - any participants scoring over 15 is excluded).
16. Use of computer games that are designed to help with memory or general cognition.
17. Presence of any medical or psychological condition that, in the opinion of the principal investigator, may compromise the study objectives.
18. Presence of contra-indications for MRI scanning.
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Douglas Mental Health University Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Véronique Bohbot
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Véronique Bohbot, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Douglas Mental Health University Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Douglas Mental Health University Institute
Verdun, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Bohbot VD, Iaria G, Petrides M. Hippocampal function and spatial memory: evidence from functional neuroimaging in healthy participants and performance of patients with medial temporal lobe resections. Neuropsychology. 2004 Jul;18(3):418-25. doi: 10.1037/0894-4105.18.3.418.
Bohbot VD, Lerch J, Thorndycraft B, Iaria G, Zijdenbos AP. Gray matter differences correlate with spontaneous strategies in a human virtual navigation task. J Neurosci. 2007 Sep 19;27(38):10078-83. doi: 10.1523/JNEUROSCI.1763-07.2007.
Iaria G, Petrides M, Dagher A, Pike B, Bohbot VD. Cognitive strategies dependent on the hippocampus and caudate nucleus in human navigation: variability and change with practice. J Neurosci. 2003 Jul 2;23(13):5945-52. doi: 10.1523/JNEUROSCI.23-13-05945.2003.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
488505
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Auto-SMIP-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.