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Behavioural Intervention
Brain Stimulation for Dementia and Memory Loss
N/A
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals must be greater than or equal to 50 years of age
Individuals must be diagnosed with Dementia and/or memory loss by a clinician
Must not have
Contraindications to rTMS including presence of a pacemaker, metal/electrical/magnetic implants not including titanium, known history of untreated or uncontrolled psychological disorders, pregnancy, history of seizure or diagnoses of epilepsy, taking any prescription medications that increase the risk of seizure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline 1-2 days pre-intervention, and 1-2 days post-intervention
Summary
This trial aims to understand if a type of brain stimulation called rTMS can improve balance in older adults. The study compares two different brain regions to see which one is more effective. The results could
Who is the study for?
This trial is for older adults experiencing cognitive decline, such as dementia or Alzheimer's Disease, who are interested in a non-drug treatment aimed at improving balance and cognitive function. Participants should be able to perform daily activities with some degree of independence.
What is being tested?
The study tests whether rTMS, a non-invasive brain stimulation technique, can improve balance by targeting either the motor cortex (M1) or the part of the brain involved in complex thinking tasks (DLPFC). The effectiveness is compared between active rTMS and placebo-like sham rTMS.
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures; however, these side effects are generally rare. The procedure is considered safe with minimal risks when performed correctly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I have been diagnosed with Dementia or memory loss by a doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have a pacemaker, metal implants (except titanium), untreated mental disorders, am not pregnant, have no history of seizures, and am not on medication that raises seizure risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline 1-2 days pre-intervention, and 1-2 days post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline 1-2 days pre-intervention, and 1-2 days post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time Up & Go (TUG) task
Secondary study objectives
Activities-Specified Balance Confidence (ABC) scale
Associative memory
Balance Assessment test
+5 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Active rTMS to M1Active Control1 Intervention
iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target M1. Participants will receive 14 days of stimulation. During each treatment day, three iTBS sessions separated by 15-minute intervals will be delivered. Each iTBS session consists of 600 stimuli delivered in 50 Hz bursts of 3 pulses at 70% of the resting motor threshold. In total, individuals will receive 1800 stimuli delivered each day as performed elsewhere . Following iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).
Group II: Active rTMS to DLPFCActive Control1 Intervention
iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target DLPFC. Participants will receive 14 days of stimulation. During each treatment day, three iTBS sessions separated by 15-minute intervals will be delivered \[13,22\]. Each iTBS session consists of 600 stimuli delivered in 50 Hz bursts of 3 pulses at 70% of the resting motor threshold. In total, individuals will receive 1800 stimuli delivered each day as performed elsewhere \[13,23,27\]. Following iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).
Group III: Placebo rTMS to M1Placebo Group1 Intervention
sham iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target M1. Participants will receive 14 days of placebo stimulation. Following sham iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,616,217 Total Patients Enrolled