NCT07212504

Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rotman Research Institute at Baycrest · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will examine the effects of combining cognitive remediation with accelerated intermittent theta burst stimulation (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults aged 55-85 with MCI or SCD. Thirty older adults will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 2-5 consecutive days, followed by 6 weeks of online cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of an a-iTBS protocol combined with cognitive training in older adults with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD) and to obtain preliminary evidence of treatment efficacy.

Conditions

• Mild Cognitive Impairment (MCI)
• Subjective Cognitive Decline (SCD)

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-11-15
• Primary completion: 2027-03-15
• Completion: 2027-03-15
• First posted: 2025-10-08
• Last updated: 2025-10-28

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study