Deep rTMS for Mild Neurocognitive Disorder in Older Adults

NCT07038798 · tracked via the Priya Life Science Canada tracker

Sponsor

St. Joseph's Healthcare Hamilton

Phase

Not applicable

Started

2025-08-26

Last updated

2025-10-06

Condition(s) studied

Mild Neurocognitive Disorder

Investigational drug(s) / intervention(s)

Brainsway H1-Coil Deep TMS SystemBrainsway H4-Coil Deep TMS SystemBrainsway H7-Coil Deep TMS System

Brainsway H1-Coil Deep TMS System: Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H1-coil.

Brainsway H4-Coil Deep TMS System: Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H4-coil.

Brainsway H7-Coil Deep TMS System: Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H7-coil.

Study summary

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

Sex

ALL

Min age

60 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * 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 * Preserved independence in everyday activities * Independently mobile (e.g., participants must be able to get in and out of a chair on their own) * Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening Exclusion Criteria: * 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 * Impairment in basic and/or instrumental activities of daily living * Substance use disorder (other than tobacco use disorder) in the past 3 months before entering the study * Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations, delirium); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion, treatment with equivalent benzodiazepine dose to lorazepam \>2 mg/day * People with severe literacy, visual, or hearing issues that affect the ability to engage in the interviews * People with recurring migraines or headaches (weekly or more) * Frequent dizziness/vertigo * Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities

Primary outcome measure(s)

Feasibility criteria 1: Protocol completion — 6 weeks
Percentage of intervention sessions completed
Feasibility criteria 2: Retention rate — 6 weeks
Percentage of participants who complete study once enrolled
Feasibility criteria 3: Screening rates and capacity — 6 weeks
Number of participants (n) screened; n enrolled as a percentage of n screened monthly
Feasibility criteria 4: Recruitment rate and capacity — 6 weeks
Total number of participants recruited and enrolled per month.
Feasibility criteria 5: Duration of intervention and assessment processes — 6 weeks
Compared to estimated times, the actual mean times (in min) from start to finish for each dTMS intervention session and mean time (in hours) from start to finish for each visit.
Feasibility criteria 6: Safety of H-coil dTMS treatment — 6 weeks
Total number of adverse events reported during the treatment sessions assessed by the Side Effects Questionnaire for dTMS (custom-developed for study). At each dTMS stimulation session, participants will complete a questionnaire to evaluate potential adverse effects of dTMS (headache, neck pain, itching and redness at the site of stimulation) according to a 4-point scale.
Tolerability of H-coil dTMS treatment — 6 weeks
Percentage of participants withdrawn or terminated following enrollment due to adverse events

Trial sites (1)

Facility	City	Region	Status
Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Recruiting

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Official registry record

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.

View NCT07038798 on ClinicalTrials.gov ↗ ← All trials in Canada