Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095063
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-11
Brief Title:
dTMS for Subjective Cognitive Decline
Sponsor:
Rotman Research Institute at Baycrest
Organization:
Rotman Research Institute at Baycrest
Study Overview
Official Title:
Effect of Deep Transcranial Magnetic Stimulation dTMS on Cognition in Older Adults With Subjective Cognitive Decline SCD
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
Deep transcranial magnetic stimulation dTMS is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline In this study the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline SCD and examine the effect of this treatment on memory other cognitive abilities and mood In addition the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography EEG
Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimers disease will be enrolled in this study
Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimers disease will be enrolled in this study
Detailed Description:
This study will examine the effects of combining cognitive remediation with neurostimulation using deep transcranial magnetic stimulation dTMS and the H7-coil to target the anterior cingulate cortex ACC in older adults at risk for developing Alzheimers disease AD Thirty older adults with subjective cognitive decline SCD and a family history of AD will participate in a single-site randomized double-blind sham-controlled cross-over trial of dTMS of the ACC in conjunction with active cognitive remediation for both sham and dTMS interventions The primary goal of the study is to establish the feasibility of dTMS and cognitive training as a means to improve cognitive abilities in SCD Secondary goals are to obtain preliminary evidence of improvement in executive function and memory abilities following dTMS and cognitive training This trial is a first step towards developing effective neurostimulation protocols to reduce cognitive decline in older adults at risk for developing AD
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?:
False
Is an FDA AA801 Violation?:
None