Recruiting

dTMS & Cognitive Training

Sponsor:

Rotman Research Institute at Baycrest

Code:

NCT07212504

Conditions

Mild Cognitive Impairment (MCI)

Subjective Cognitive Decline (SCD)

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Brainsway H7-Coil Deep TMS System

Sham Brainsway H1-Coil Deep TMS System

Study Details

Brief summary:

The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.

Conditions

Mild Cognitive Impairment (MCI)

Subjective Cognitive Decline (SCD)

Study ID

NCT07212504

Start date

Nov 15, 2025

Status verified date

Sep, 2025

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 20-40 sessions of iTBS dTMS and 6-weeks of online cognitive remediation

sham comparator: 20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation

Interventions

Active Brainsway H7-Coil Deep TMS System

Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered 6-8 times a day for 2-5 consecutive days.

Sham Brainsway H1-Coil Deep TMS System

In addition to the active H7-coil, a sham coil is included in the H1-coil helmet.The sham treatment will be administered using the H1-coil helmet 6-8 times a day for 2-5 consecutive days.

Primary outcome measure

  • Percentage of dTMS sessions attended by participants [ Time Frame: 1 week ]
  • Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ) [ Time Frame: 9 weeks ]
  • The number of participants who prematurely withdraw and reasons for withdrawal [ Time Frame: 9 weeks ]
  • Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5 [ Time Frame: 9 weeks ]
  • Change from baseline executive function scores on computerized neuropsychological battery following final session on day 5 [ Time Frame: 9 weeks ]

Central Contacts and Locations

Central contacts

Amanda Chao, MPH

416-785-2500preventad@research.baycrest.org

Linda Mah, MD

416-785-2500preventad@research.baycrest.org

Locations

Rotman Research Institute at Baycrest

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Linda Mah, MD

416-785-2500preventad@research.baycrest.org

More Information

Sponsor

Rotman Research Institute at Baycrest

Last update posted

Oct 28, 2025

Last verified

Sep, 2025

Keywords

  • Mild Cognitive Impairment
  • Subjective Cognitive Decline
  • Transcranial Magnetic Stimulation (TMS)
  • Intermittent Theta Burst Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Rotman Research Institute at Baycrest on 2025-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.