Active Brainsway H7-Coil Deep TMS SystemSham Brainsway H1-Coil Deep TMS System
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 6-8 times a day for 2-5 consecutive days.
Sham Brainsway H1-Coil Deep TMS System: In addition to the active H7-coil, a sham coil is included in the H1-coil helmet.The sham treatment will be administered using the H1-coil helmet 6-8 times a day for 2-5 consecutive days.
Study summary
The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
Eligibility
Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* 55 - 85 years of age (on the day of randomization)
* are male or post-menopausal female
* have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score \< 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
* score 24 or higher on the Mini Mental State Examination (MMSE)
* 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
Exclusion Criteria:
* have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe.
* 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 history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
* 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 untreated hypo- or hyper-thyroidism
* have unstable medical condition(s)
* have any other known contraindications to TMS
* are on unstable doses of any psychotropic medication such as antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
* regularly use benzodiazepines or other hypnotics within 2 weeks of randomization
Primary outcome measure(s)
Percentage of dTMS sessions attended by participants — 1 week
Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ) — 9 weeks The AEQ asks about symptoms related immediately after TMS administration where patients rate symptom severity from 1 (absent) to 4 (severe) and whether they believe it is related to TMS from 1 (no) to 5 (definitely).
The number of participants who prematurely withdraw and reasons for withdrawal — 9 weeks
Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5 — 9 weeks Memory score from memory tests in the neuropsychological battery at baseline will be compared to after 5 days of TMS and after 6 weeks of cognitive training the active intervention group compared to the sham. A higher memory score indicates better memory performance. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Change from baseline executive function scores on computerized neuropsychological battery following final session on day 5 — 9 weeks Executive function scores from tests on the neuropsychological battery will be compared from baseline to after days of dTMS and after 6 weeks of cognitive training in the active intervention group compared to sham. A higher score on these tests indicate greater executive functioning. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Trial sites (1)
Facility
City
Region
Status
Rotman Research Institute at Baycrest
Toronto
Ontario
Recruiting
More Rotman Research Institute at Baycrest trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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