Deep TMS treatment for depression and cognitive issues in older adults
Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)
This study is testing if a new brain treatment can help older adults with Alzheimer's or mild cognitive issues who also have depression feel better and think more clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Rotman Research Institute at Baycrest Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03665831 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil on older adults over 60 diagnosed with mild to early-moderate Alzheimer's disease or mild cognitive impairment, who also suffer from Major Depressive Disorder. Participants will receive 4 weeks of daily active dTMS treatment, with assessments of depression and cognitive function conducted before and after the treatment period. The study aims to determine the safety, efficacy, and long-term effects of this intervention on both emotional and cognitive measures.
Who should consider this trial
Good fit: Ideal candidates are older adults over 60 with mild to early-moderate Alzheimer's disease or mild cognitive impairment and comorbid Major Depressive Disorder who have not responded to or tolerated antidepressant medications.
Not a fit: Patients with metal implants in their head or a history of increased intracranial pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for older adults suffering from both depression and cognitive impairment.
How similar studies have performed: Previous studies have shown promising results with similar approaches using TMS for depression, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5 * have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years * did not respond to or did not tolerate antidepressant treatment * 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 * have an informant/study partner who is able to complete study questionnaires regarding the participant Exclusion Criteria: * have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips) * 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 significant heart disease or history of stroke * Modified Hachinski Score (MHIS) \> 3 (to exclude those with significant vascular component to memory loss) * have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD * 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 * are taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure * are taking memantine * have a history of abnormal MRI of the brain * have significant hearing loss requiring use of hearing aids * have untreated hypo- or hyper-thyroidism
Where this trial is running
Toronto, Ontario
- Rotman Research Institute at Baycrest — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Amanda Rahmadian, BSc
- Email: dtms@research.baycrest.org
- Phone: 416-785-2500
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.