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NCT05855850
Deep rTMS for Depression in Older Adults
NA trial testing Brainsway H4-Coil Deep TMS System in Major Depressive Disorder in 21 participants. Completed in 3 June 2024.
3 June 2024
Quick facts
| Lead sponsor | St. Joseph's Healthcare Hamilton |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 21 |
| Start date | 18 April 2023 |
| Primary completion | 3 June 2024 |
| Estimated completion | 3 June 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Brainsway H4-Coil Deep TMS System
- Brainsway H7-Coil Deep TMS System
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
St. Joseph's Healthcare Hamilton — full company profile →
Who can join
Adults 60 to 85, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to: (1) assess the feasibility and tolerability of two active dTMS coils - H4 and H7 - in older adults with depression; and (2) clinical response measured by change from baseline on the Hamilton Depression Rating Scale- 24 item; changes in cognitive function through neuropsychological assessment; and changes in regional electrophysiological activity and functional connectivity indexed by EEG. Through a parallel design, participants will complete a four-week course of five dTMS sessions per week, for a total of 20 stimulation sessions. Participants will be randomly assigned to either coil (H4 or H7) and will complete questionnaires examining side effects, mental health symptoms, and cognition. Participant EEG data will be measured and collected at baseline and at the end of each week. Collectively, the study will address the absolute and differential feasibility and tolerability of the two active coils to provide preliminary data for a future randomized controlled trial comparing one or both of these novel interventions to the established H1-coil and a sham stimulation (placebo) control.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05855850
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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Currently open trials in the same condition.
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- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other St. Joseph's Healthcare Hamilton trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05855850 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton
- Last refreshed: 17 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05855850.
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