Deep TMS to help thinking in older adults with mild cognitive decline
Feasibility and Tolerability of Deep Repetitive Transcranial Magnetic Stimulation for Mild Neurocognitive Disorder in Older Adults: A Pilot Study (DeepMIND)
NA · St. Joseph's Healthcare Hamilton · NCT07038798
This pilot will try three types of deep transcranial magnetic stimulation (H1, H4, H7 coils) to see how tolerable they are and whether they affect thinking, mood, sleep, and brain activity in adults aged 60–90 with mild neurocognitive disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton (other) |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT07038798 on ClinicalTrials.gov |
What this trial studies
This open-label, parallel pilot assigns participants aged 60–90 to one of three dTMS H-coils (H1, H4, H7) and delivers a six-week course of 20 stimulation sessions. Feasibility and tolerability are measured with side-effect checklists and mental-health questionnaires, while cognition is measured with neuropsychological tests and CNS Vital Signs and brain activity is recorded with EEG at baseline, midpoint, end point, and follow-up. Self-report mood and sleep questionnaires are collected at the same timepoints to capture noncognitive effects. The trial will compare absolute and differential tolerability across coils to provide preliminary data for a future randomized sham-controlled trial.
Who should consider this trial
Good fit: Adults aged 60–90 with self-reported recent cognitive decline, objective mild impairment on testing, preserved independence in daily activities, and stable psychotropic medications are the intended participants.
Not a fit: People with severe depression, bipolar or psychotic disorders, significant neurological illness explaining their cognitive problems, impaired basic or instrumental activities of daily living, recent substance use disorders, or standard rTMS contraindications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, one of the coils could offer a tolerable, noninvasive option to improve or stabilize cognition, mood, or sleep in older adults with mild neurocognitive disorder.
How similar studies have performed: dTMS is FDA-approved for several psychiatric conditions and small studies have suggested possible cognitive benefits in Alzheimer's and other neurodegenerative disorders, but its use in mild NCD remains preliminary and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario
- Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Neurocognitive Disorder, Mild NCD, Mild Cognitive Impairment, Deep Transcranial Magnetic Stimulation, deep TMS, dTMS, H coil, H-coil