Accelerated deep TMS targeting the anterior cingulate for depression in older adults
Feasibility, Tolerability, and Preliminary Efficacy for Non-Invasive Neuromodulation of the Anterior Cingulate Cortex for Depression (NACC-D) in Older Adults Using Deep Transcranial Magnetic Stimulation With an Accelerated Intermittent Theta Burst Protocol
This study will test whether a 5-day accelerated deep TMS treatment aimed at the anterior cingulate can reduce depression in people aged 60–85 who have not tolerated or responded to antidepressants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Rotman Research Institute at Baycrest Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07212465 on ClinicalTrials.gov |
What this trial studies
This is a single-site, double-blind, randomized, sham-controlled trial using an accelerated intermittent theta burst protocol (a-iTBS) delivered with the Brainsway H7 deep TMS coil to target the anterior cingulate cortex. Twenty-four older adults (ages 60–85) with treatment-resistant major depressive disorder will receive multiple daily dTMS sessions over five consecutive days, with either active or sham stimulation. The primary aim is to establish feasibility and tolerability of the accelerated schedule in this age group and to collect preliminary efficacy data on depressive symptom reduction. Outcomes will compare symptom change between active and sham groups and monitor safety measures such as adverse events and tolerability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60–85 with DSM-5 major depressive disorder whose current episode has lasted more than 4 weeks and less than 5 years and who have not achieved remission or could not tolerate at least one adequate antidepressant trial, are stable on meds for 2 months, and can attend the treatment schedule.
Not a fit: People with implanted metal devices in the head, cardiac pacemakers, a history of increased intracranial pressure or seizure risk, or other TMS contraindications are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could provide a fast, well-tolerated option to reduce depressive symptoms in older adults who have not benefited from antidepressant medications.
How similar studies have performed: Previous TMS and intermittent theta burst studies, including some accelerated iTBS protocols, have shown benefit in major depression, but using the H7 deep coil to target the anterior cingulate in older, treatment-resistant patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * are between 60- 85 years old (on the day of randomization) * 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/did not tolerate, or failed to achieve remission with at least one antidepressant trial of 8 week minimum duration * 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 your 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 * require daily doses of benzodiazepines or hypnotics within two weeks of randomization
Where this trial is running
Toronto, Ontario
- Rotman Research Institute at Baycrest — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Linda Mah, MD — Baycrest Rotman Research Institute
- Study coordinator: Amanda Chao, MPH
- Email: preventad@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.