dTMS for Subjective Cognitive Decline

Status Recruiting

Clinical Trial 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 Alzheimer's disease will be enrolled in this study.

Clinical Trial 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 Alzheimer's 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06095063
Study type	Interventional
Source	Rotman Research Institute at Baycrest
Contact	Amanda Rahmadian
Phone	416-785-2500
Email	dtms@research.baycrest.org
Status	Recruiting
Phase	N/A
Start date	November 15, 2023
Completion date	November 15, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Completed	`NCT04079803` - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Phase 2
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT04520698` - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease	N/A
Active, not recruiting	`NCT04606420` - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease	N/A
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Terminated	`NCT03672474` - REGEnLIFE RGn530 - Feasibility Pilot	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Recruiting	`NCT04522739` - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease	Phase 4
Recruiting	`NCT04949750` - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease	N/A
Recruiting	`NCT05557409` - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation	Phase 3
Recruiting	`NCT05288842` - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Completed	`NCT06194552` - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07	Phase 1
Completed	`NCT03239561` - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants	Early Phase 1
Completed	`NCT03184467` - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients	Phase 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated	`NCT03487380` - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT05328115` - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease	Phase 1
Completed	`NCT05562583` - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.