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dTMS + Cognitive Training for Mild Cognitive Impairment

N/A

Recruiting

Led By Linda Mah

Research Sponsored by Rotman Research Institute at Baycrest

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Have a history of stroke or other brain lesions

Have untreated hypo- or hyper-thyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 19 weeks

Summary

This trial will investigate if combining targeted brain stimulation and cognitive training can help improve cognition and mood in older adults with SCD.

Who is the study for?

This trial is for adults aged 55 to 70 with subjective cognitive decline and a family history of Alzheimer's. Participants must score at least 26 on the MoCA test, be stable on medications, and have someone to report on their condition. Exclusions include significant heart conditions, brain lesions or metal implants in the head (excluding dental), certain psychiatric disorders, substance abuse, pregnancy, untreated thyroid issues, hearing loss requiring aids, epilepsy or family history of it.

What is being tested?

The study tests if combining Deep Transcranial Magnetic Stimulation (dTMS) using Brainsway H7-Coil with cognitive training improves memory and cognition in those experiencing early signs of cognitive decline. The effects will also be measured through EEG brain activity monitoring.

What are the potential side effects?

Potential side effects from dTMS may include headache or scalp discomfort at the stimulation site during treatment sessions. There's also a small risk of inducing seizures; however this is rare especially when safety protocols are followed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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A close family member had Alzheimer's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or other brain issues in the past.

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I have untreated thyroid issues.

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I have a medical condition that is not currently stable.

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I have a history of high brain pressure, which raises my seizure risk.

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I have a serious heart condition.

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My family has a history of epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 19 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~19 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of scheduled treatment sessions that are attended by study participants

Secondary study objectives

Change in baseline in scores on the Geriatric Anxiety Inventory (GAI).

Change in baseline in scores on the Geriatric Depression Scale (GDS).

Change in baseline in scores on the Neuropsychiatric Inventory Questionnaire (NPI-Q)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 20 sessions of dTMS and Cognitive TrainingExperimental Treatment2 Interventions

Participants will receive dTMS followed by computerized cognitive training. dTMS: The motor threshold (MT) will be measured by delivering single stimulations to the motor cortex with gradually increased intensity. After defining the MT, the coil will be positioned anterior to the hot spot using the ruler on the participant's cap, and a dTMS session will be performed with the dosing of the stimulus intensity titrated slowly to approximately 120% of the motor threshold. On Day 1 of the treatment, stimulation will be delivered at an intensity ranging from 80% to 100% of the participant's MT depending on their initial tolerance to the stimulation. Stimulation intensity will then be slowly titrated by sequentially increasing the intensity by 10% over the remaining days of the first week until a maximum intensity of 120% of MT is achieved depending on the tolerability of the patient. Immediately following dTMS, participants will complete 20-30 minutes of cognitive training.

Group II: 20 sessions of sham/control stimulation and Cognitive TrainingPlacebo Group2 Interventions

Participants will receive sham intervention followed by computerized cognitive training. The sham intervention consists of treatment with similar technical parameters which induce scalp sensations but do not penetrate into the brain. Immediately following dTMS, participants will complete 20-30 minutes of cognitive training.

0 / 7Eligibility criteria met