Accelerated deep TMS to boost memory and thinking in older adults with mild memory problems
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
NA · Rotman Research Institute at Baycrest · NCT07212504
We will test whether a short, intensive course of deep transcranial magnetic stimulation to the anterior cingulate plus online cognitive training can improve memory and thinking in people aged 55–85 with mild cognitive impairment or subjective memory decline.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Rotman Research Institute at Baycrest (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07212504 on ClinicalTrials.gov |
What this trial studies
This single-site, double-blind, randomized, sham-controlled trial will enroll 30 adults aged 55–85 with MCI or subjective cognitive decline. Participants will receive accelerated intermittent theta-burst deep TMS using the H7 coil targeting the anterior cingulate, with multiple sessions per day over 2–5 consecutive days, or a sham equivalent. Both groups will then complete six weeks of online cognitive remediation, with outcomes focused on safety, tolerability, and preliminary cognitive change. The primary aim is to establish feasibility of the accelerated a-iTBS schedule combined with cognitive training and to gather early evidence of treatment effect.
Who should consider this trial
Good fit: Ideal candidates are adults 55–85 with MCI or subjective cognitive decline, MMSE ≥24, stable medications, able to follow the intensive schedule, and without contraindications to TMS.
Not a fit: People with more advanced dementia, active neurological conditions, implanted brain stimulators or incompatible metal in the head, or those unable to attend intensive in-person sessions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a brief, well-tolerated add-on that improves memory and other cognitive abilities in older adults with early memory problems.
How similar studies have performed: Prior TMS and iTBS studies in older adults have shown mixed but sometimes promising cognitive effects, while accelerated deep TMS targeting the anterior cingulate combined with cognitive training is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 55 - 85 years of age (on the day of randomization) * are male or post-menopausal female * have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score \< 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD * score 24 or higher on the Mini Mental State Examination (MMSE) * are willing to provide informed consent * are able to follow the treatment schedule * are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications) * have a satisfactory safety screening questionnaire for TMS Exclusion Criteria: * have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe. * have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures * have a cardiac pacemaker * have an implanted medication pump * have a central venous line * have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia * have a history of substance abuse in the last 6 months * have a history of stroke or other brain lesions * have a personal history of epilepsy * have a family history of epilepsy * are a pregnant or breast-feeding woman * have a history of abnormal MRI of the brain * have untreated hypo- or hyper-thyroidism * have unstable medical condition(s) * have any other known contraindications to TMS * are on unstable doses of any psychotropic medication such as antidepressants, antipsychotic, mood stabilizers or memory enhancing medications * regularly use benzodiazepines or other hypnotics within 2 weeks of randomization
Where this trial is running
Toronto, Ontario
- Rotman Research Institute at Baycrest — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Linda Mah, MD — Baycrest Rotman Research Institute
- Study coordinator: Amanda Chao, MPH
- Email: preventad@research.baycrest.org
- Phone: 416-785-2500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Cognitive Impairment, Subjective Cognitive Decline, Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation