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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 19 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

A close family member had Alzheimer's disease.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of scheduled treatment sessions that are attended by study participants

Secondary outcome measures

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 / 1Eligibility criteria met

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Who is running the clinical trial?

Rotman Research Institute at BaycrestLead Sponsor

10 Previous Clinical Trials

432 Total Patients Enrolled

BrainswayIndustry Sponsor

37 Previous Clinical Trials

2,722 Total Patients Enrolled

Centre for Addiction and Mental HealthOTHER

356 Previous Clinical Trials

81,428 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over the age of 18 eligible to join this research endeavor?

"This trial is looking for patients between 55 and 70 years of age. There are 39 studies open to those below the age of majority, while 988 medical trials have been opened up to individuals aged 65 or above."

Answered by AI

Does the protocol for this research permit me to participate?

"Applicants for this trial must have a diagnosis of Alzheimer's disease and fit within the age range of 55 to 70. There is a total recruitment goal of 30 participants."

Answered by AI

What is the current status of recruitment for this investigation?

"Affirmative. According to the information displayed on clinicaltrials.gov, this trial is presently inviting participants with an initial posting date of November 15th 2023 and a recent edit made on October 20th 2023. The study requires 30 subjects across one medical centre for enrolment."

Answered by AI

How extensive is the population being evaluated for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking patients since its inception on November 15th 2023. The most recent update was made October 20th of that same year and the trial requires 30 participants from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

dTMS for Subjective Cognitive Decline

Linda Mah, MD 2023. "dTMS for Subjective Cognitive Decline". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095063.