← Back to Search

Transcranial Magnetic Stimulation

Deep rTMS for Depression in Older Adults (DIVINE Trial)

N/A

Recruiting

Led By Dante Duarte, MD, MSc, PhD

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-weeks + 2-week follow-up

Awards & highlights

DIVINE Trial Summary

This trial will assess the safety, effectiveness, and side effects of two new forms of magnetic brain stimulation to treat depression in seniors.

Who is the study for?

This trial is for older adults aged 60-85 with major depressive disorder (MDD) who haven't responded well to at least one antidepressant. They must be able to consent, have a stable medication regimen, and score at least 20 on the HDRS-24 scale. Exclusions include bipolar or psychotic disorders as primary diagnoses, recent substance abuse, possible dementia, rTMS contraindications like metal implants or seizure history.Check my eligibility

What is being tested?

The study tests two Deep Transcranial Magnetic Stimulation (dTMS) coils - H4 and H7 - for treating depression in older adults. Participants will undergo five sessions per week over four weeks using either coil randomly assigned. The effects on mood, cognition, and brain activity are measured through questionnaires and EEG.See study design

What are the potential side effects?

Possible side effects of dTMS may include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. Rarely it can cause seizures; however this is uncommon especially if exclusion criteria are properly followed.

DIVINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-weeks + 2-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-weeks + 2-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-weeks + 2-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility criteria 1: Protocol completion

Feasibility criteria 2: Retention rate

Feasibility criteria 3: Screening rates and capacity

+4 more

Secondary outcome measures

Change from baseline on the General Anxiety Disorder- 7 item (GAD-7)

Change from baseline on the Hamilton Depression Rating Scale- 24 item (HDRS-24).

Change from baseline on the Patient Health Questionnaire (PHQ - Somatic Symptoms)

+4 more

DIVINE Trial Design

2Treatment groups

Experimental Treatment

Group I: Active H7-coil dTMS treatmentExperimental Treatment1 Intervention

Group II: Active H4-coil dTMS treatmentExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor

196 Previous Clinical Trials

25,524 Total Patients Enrolled

10 Trials studying Depression

537 Patients Enrolled for Depression

Peter Boris Centre for Addictions Research (PBCAR)UNKNOWN

Dante Duarte, MD, MSc, PhDPrincipal InvestigatorPeter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

Media Library

Brainsway H4-Coil Deep TMS System (Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05855850 — N/A

Depression Research Study Groups: Active H4-coil dTMS treatment, Active H7-coil dTMS treatment

Depression Clinical Trial 2023: Brainsway H4-Coil Deep TMS System Highlights & Side Effects. Trial Name: NCT05855850 — N/A

Brainsway H4-Coil Deep TMS System (Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05855850 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment available to individuals beyond the age of fifty?

"This medical experiment requires qualified participants to be aged between 60 and 85 years old. Additionally, there are 212 trials for people below the age of 18 while 1016 studies focus on those above 65."

Answered by AI

What is the current availability of participation in this research study?

"According to clinicaltrials.gov, enrolment is still in progress for this research project which was initially advertised on April 18th 2023 and has since been updated last May 9th 2023."

Answered by AI

How many participants are being taken in for this research endeavor?

"Affirmative. According to the information hosted on clinicaltrials.gov, this trial is actively recruiting participants since its inception on April 18th 2023 and most recently updated on May 9th 2023. The medical study seeks to enrol up to 20 patients at a single site."

Answered by AI

What criteria must prospective participants fulfill in order to join this medical experiment?

"This clinical trial is seeking around 20 elderly adults with depression as participants. The age criteria for this study requires people to be between the ages of 60 and 85."

Answered by AI

Could you explain the major aims of this experimentation?

"This trial is assessing the feasibility criteria of retention rate over a 4 week period as its primary outcome. Secondary outcomes include changes from baseline in Geriatric Depression 30-item Scale (GDS-30), General Anxiety Disorder- 7 item (GAD-7) and Pittsburgh Sleeping Quality Index (PSQI). All these assessments will be conducted at baseline, midpoint, endpoint visits and 2 weeks after completion of study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deep rTMS for Depression in Older Adults

Dante Duarte 2023. "Deep rTMS for Depression in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05855850.

All > Major Depressive Disorder