Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-07 @ 6:50 AM
Study NCT ID:
NCT07212504
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
Sponsor:
Rotman Research Institute at Baycrest
Organization:
Study Overview
Official Title:
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NACC-EC
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: