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Deep rTMS for Depression in Older Adults

NCT05855850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-06-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Brainsway H4-Coil Deep TMS System

Participants assigned to this arm will complete a 4-week course of 5 dTMS sessions per week (using the Brainsway H4-coil), for a total of 20 stimulation sessions. We will follow the standard Health Canada and FDA-approved protocol for depression: 18 Hz and 55 trains, for a total of 1980 pulses.

DEVICE

Brainsway H7-Coil Deep TMS System

Participants assigned to this arm will complete a 4-week course of 5 dTMS sessions per week (using the Brainsway H7-coil), for a total of 20 stimulation sessions. We will follow the standard Health Canada and FDA-approved protocol for depression: 18 Hz and 55 trains, for a total of 1980 pulses.

Sponsors & Collaborators

  • Peter Boris Centre for Addictions Research (PBCAR)

    collaborator UNKNOWN

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Dante Duarte, MD, MSc, PhD · Peter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

  • James MacKillop, PhD · Peter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

  • Emily MacKillop, PhD, ABPP-CN · Peter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2024-06-03
Completion
2024-06-03

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855850 on ClinicalTrials.gov