Deep rTMS for Mild Neurocognitive Disorder in Older Adults
ConditionMild Neurocognitive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorSt. Joseph's Healthcare Hamilton
About this trial
This study aims to: (1) assess the feasibility and tolerability of three deep transcranial magnetic stimulation (dTMS) coils H1, H4, and H7 in older adults with mild neurocognitive disorder (mild NCD); and (2) evaluate changes in cognition through neuropsychological testing, brain activity through EEG, and mood and sleep through self-report questionnaires. Participants will be assigned to one of three arms: H1- coil vs. H4-coil vs. H7-coil, and all participants will complete assessments examining dTMS side effects, mental health symptoms, and cognition. EEG, questionnaires, and CNS vital signs will be measured at baseline, midpoint (after 10th session- before dTMS treatment on visit 11), and end point, as well as follow up. Collectively, the study will address the absolute and differential feasibility and tolerability of the H1, H4 and H7 coils to provide preliminary data for a future randomized controlled trial comparing this novel intervention to a sham stimulation (placebo) control.
Eligibility criteria
Qualifiers
60 - 90 years old
Able to provide informed consent to participate in the study
Subjective concern of mild decline in cognitive function over the past year
Mild impairment in cognitive performance
Disqualifiers
Currently receiving treatment or subjective need for treatment for bipolar I or II disorder; psychotic disorder
Active suicidal behavior
Severe depression and/or anxiety
Other neurological or psychiatric disorders accounting for the cognitive deficits
Trial design
Treatments tested in this trial
- Brainsway H1-Coil Deep TMS System
- Brainsway H4-Coil Deep TMS System
- Brainsway H7-Coil Deep TMS System
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov