dTMS for Subjective Cognitive Decline

Alzheimer Disease Clinical Trial

Official title:

Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095063
• Other study ID #: 21-01
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: October 2023
• Source: Rotman Research Institute at Baycrest
• Contact: Amanda Rahmadian
• Phone: 416-785-2500
• Email: dtms[@]research.baycrest.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 15, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

• have a family history of late onset sporadic Alzheimer's disease (AD) as defined by having a first degree relative, living or deceased, with a probable or confirmed diagnosis of AD

• have subjective memory decline and concern about memory changes

• score 26 or higher on the Montreal Cognitive Assessment (MoCA)

• 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

• have an informant/study partner who is able to complete study questionnaires regarding the participant

Exclusion Criteria:

• have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)

• 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 significant heart condition

• have current depression or a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD

• 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 significant hearing loss requiring use of hearing aids

• have untreated hypo- or hyper-thyroidism

• have TMS contraindications

• have unstable medical condition(s)

• regularly use benzodiazepines or other hypnotics within 2 weeks of randomization

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Subjective Cognitive Decline

Intervention

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 daily for 4 consecutive weeks.
• Sham Brainsway H7-Coil Deep TMS System
In addition to the active H-coil, a sham coil is included in the system. The active and sham coils are connected to a control switch, which alternates between real and sham operation modes. The sham treatment will be administered daily for 4 consecutive weeks.

Other:
• Cognitive Training
Cognitive training will be conducted using the BrainHQ software program.

Locations

Country	Name	City	State
Canada	Rotman Research Institute at Baycrest	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Rotman Research Institute at Baycrest	Brainsway, Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of scheduled treatment sessions that are attended by study participants	There are in total 20 sessions of dTMS intervention and 20 sessions of sham stimulation.	19 weeks
Secondary	Change in baseline memory performance on a neuropsychological battery	Memory score from the neuropsychological battery at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.	19 weeks
Secondary	Change in executive function performance on a neuropsychological battery	Executive function scores from the neuropsychological battery at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.	19 weeks
Secondary	Change in baseline in scores on the Geriatric Depression Scale (GDS).	GDS is a 15-item self-report scale that measures an elderly individual's mood. A score greater than 5 suggests that the individual may be depressed. Administration time is approximately 5 minutes.; The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.	19 weeks
Secondary	Change in baseline in scores on the Geriatric Anxiety Inventory (GAI).	The GAI is a 20-item self-report measure of anxiety developed for older adults. Administration time is approximately 5 minutes.; The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.	19 weeks
Secondary	Change in baseline in scores on the Neuropsychiatric Inventory Questionnaire (NPI-Q)	The NPI assesses dementia-related behavioural symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioural disturbances and appetite and eating abnormalities. Administration time is approximately 15 minutes.; The scores at baseline will be compared to 4 weeks of intervention and at 1-month follow-up.	19 weeks
Secondary	Change in slow wave and resting state activity	Measured with electroencephalography (EEG) following 4 weeks of intervention and at 1-month follow-up.	17 weeks