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Major Depressive DisorderNCT05855850

Deep rTMS for Depression in Older Adults

A study testing Brainsway H4-Coil Deep TMS System and Brainsway H7-Coil Deep TMS System in people with Major Depressive Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Brainsway H4-Coil Deep TMS System and Brainsway H7-Coil Deep TMS System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteCanada
Study dates
18 Apr 2023to 3 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 60 - 85 years old
  • Able to provide informed consent to participate in the study
  • MDD diagnosis, single or recurrent episode, assessed using Evaluation of the Diagnostic Assessment Research Tool (DART) Screener for DSM-5 Mood Disorder Module
  • Total score of at least 20 on the 24-item Hamilton Depression Rating Scale (HDRS-24) at screening visit
  • Treatment resistance to antidepressant pharmacotherapy during the current episode as indexed by Antidepressant Treatment History Form - Short Form (ATHF - SF). Specifically, participants will be required to have failed at least one or to have had an inadequate trial (including intolerance) to at least two antidepressants in the current episode
  • Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening

Who cannot join

  • Primary diagnosis of bipolar I or II disorder; psychotic disorder; obsessive-compulsive, post-traumatic stress, anxiety, or personality disorder; participants with anxiety or personality disorders will be eligible if is not their primary diagnosis
  • Active suicidal behavior
  • Substance dependence/abuse in the past 3 months before entering the study (this will be screened via self-report and verified by urine screening test)
  • Possible dementia diagnosis based on a Mini Mental Status Exam (MMSE) score of <24 and clinical presentation of dementia
  • Unsuccessful ECT treatment on the current episode
  • Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion >300 mg/day as it is associated with risk of seizures, treatment with equivalent benzodiazepine dose to lorazepam >2 mg/day
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  • People with severe literacy, visual, or hearing issues that affect their ability to engage in the interviews
  • People with recurring migraines or headaches (weekly or more).
  • Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L9C 0E3

Other trials in Canada

About this study

Official title: DIfferential Feasibility and Tolerability of Deep repetitiVe transcranIal MagNEtic Stimulation for Depression in Older Adults (DIVINE Trial): A Pilot Study

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.

Read the detailed description

Transcranial magnetic stimulation (TMS) is a non-invasive therapeutic technique used to stimulate regions of the brain using magnetic pulses. Repeated TMS delivers sequences of pulses for multiple days in a row and is an approved treatment for several psychiatric conditions. Deep TMS (dTMS) is a new technique that uses modified magnetic Hesed coils (H-coils) to stimulate deeper regions of the brain and has been FDA- and Health Canada-approved for major depressive disorder (MDD), obsessive-compulsive disorder, smoking cessation, and anxious-depression in adults. For older adults (60+), traditional rTMS has also shown efficacy for MDD (60+) and one RCT has found benefit for the H1 dTMS coil, but no trials have examined the H4 and H7 coils in this population. This innovative pilot study will explore dTMS feasibility and tolerability (i.e., side effects, impacts on mental health and cognition) of these two dTMS coils (H4, targeting insula and H7, targeting anterior cingulate cortex) in older adults with depression. The pilot will provide critical preliminary data for a future trial comparing these novel interventions to the H1-coil and a sham stimulation control. There is sparse literature examining the effects of dTMS on cognition, as measured by neuropsychological testing, and brain activity, as measured by electroencephalogram (EEG), while comparing different dTMS H-coils. Therefore, a second feature of the design includes assessing both domains over the course of treatment. The results will lay the foundation for a future randomized controlled trial examining the efficacy and mechanisms of one or both of these novel forms of neurostimulation for MDD in older adults.

Being tested
Brainsway H4-Coil Deep TMS System, Brainsway H7-Coil Deep TMS System
Keywords
Major Depressive Disorder, MDD, depressive disorder, depression, late-life depression, mood disorders, deep transcranial magnetic stimulation, deep TMS, dTMS, H coil, H-coil, older adults, H4-coil, H7-coil
Medical subject headings
Depressive Disorder, Major, Depressive Disorder, Depression, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brainsway H4-Coil Deep TMS SystemDevice

    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.

  • Brainsway H7-Coil Deep TMS SystemDevice

    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.

Study groups in NCT05855850
Study groupRoleWhat they receive
Active H4-coil dTMS treatmentExperimentalNot described
Receives: Device: Brainsway H4-Coil Deep TMS System
Active H7-coil dTMS treatmentExperimentalNot described
Receives: Device: Brainsway H7-Coil Deep TMS System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility criteria 1: Protocol completion

    Percentage of intervention sessions completed

    Measured: 4 weeks

  2. Feasibility criteria 2: Retention rate

    Percentage of participants who complete study once enrolled

    Measured: 4 weeks

  3. Feasibility criteria 3: Screening rates and capacity

    Number of participants (n) screened; n enrolled as a percentage of n screened monthly

    Measured: 4 weeks

  4. Feasibility criteria 4: Recruitment rate and capacity

    Total number of participants recruited and enrolled per month.

    Measured: 4 weeks

  5. Feasibility criteria 5: Duration of intervention and assessment processes

    Compared to estimated times, the actual mean times (in min) from start to finish for each dTMS intervention session and mean time (in hours) from start to finish for each visit.

    Measured: 4 weeks

  6. Feasibility criteria 5: Safety of H-coil dTMS treatment

    Total number of adverse events reported during the treatment sessions assessed by the Side Effects Questionnaire for dTMS (custom-developed for study). At each dTMS stimulation session, participants will complete a questionnaire to evaluate potential adverse effects of dTMS (headache, neck pain, itching and redness at the site of stimulation) according to a 4-point scale.

    Measured: 4 weeks

  7. Tolerability of H-coil dTMS treatment

    Percentage of participants withdrawn or terminated following enrollment due to adverse events

    Measured: 4 weeks

Secondary outcomes (7)

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

    The Hamilton Depression Rating Scale (24 item) will be used as the primary measure of depression. Symptoms of depression will be assessed with the HDRS- 24 item (a 24-item depression checklist) at multiple visits: the in-person screen (V0), baseline (V1), end-of-week dTMS sessions (V5, V10, V15, V20), and the 2-week follow-up. Scores range from 0 (min) to 75 (max), with a score of ≥ 20 indicating a moderate-to-severe depression. Lower scores may indicate mild depression or remission.

    Measured: 4-weeks + 2-week follow-up

  2. Changes from baseline on the Geriatric Depression 30-item Scale (GDS-30)

    The Geriatric Depression 30-item Scale (GDS-30) will be used as a second measure of depression, a 30-item checklist, at the baseline (V1), midpoint (V10) and endpoint (V20) visits and at the 2-week follow-up. Scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

    Measured: 4-weeks + 2-week follow-up

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

    Symptoms of anxiety will be assessed using this 7-item questionnaire at the baseline (V1), midpoint (V10) and endpoint (V20) visits and at the 2-week follow-up. Scores of 0-4 indicate minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; and 15 or greater: severe anxiety.

    Measured: 4-weeks + 2-week follow-up

  4. Change from baseline on the Pittsburgh Sleeping Quality Index (PSQI)

    Sleep will be monitored and assessed using the Pittsburgh Sleeping Quality Index (PSQI) at the baseline (V1), midpoint (V10) and endpoint (V20) visits and at the 2-week follow-up. Each of component of the PSQI is issued a score ranging from 0 to 3, with 3 indicating the greatest dysfunction.

    Measured: 4-weeks + 2-week follow-up

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

    Somatic symptoms will be evaluated using the Patient Health Questionnaire (PHQ) somatic inventory at the baseline (V1), midpoint (V10) and endpoint (V20) visits and at the 2-week follow-up. Scores range from 0 to 30: ≥ 5 = mild, ≥ 10 = moderate, and ≥ 15 = severe levels of somatization.

    Measured: 4-weeks + 2-week follow-up

  6. Changes from baseline in resting-state EEG

    Using electroencephalography (EEG), we will assess alpha, theta and gamma rhythms in fronto-temporo-parietal region, including assessment of connectivity and coherence. We will additionally measure cross-frequency coupling named theta (4-8Hz)-gamma (>25Hz) phase-amplitude coupling (PAC). We will also investigate phase synchronization in upper theta frequency band between prefrontal and temporal areas. Changes in these EEG parameters will be correlated with changes in mood severity and cognitive status, with a focus on working memory improvements. EEG will be performed before dTMS sessions at baseline (V1) and at the end of each week (V5, V10, V15 and V20) by using a wireless dry electrode portable EEG system (CGX Quick 20r). Resting state connectivity, coherence, PAC, and synchronization assessed by EEG will use standardized data processing pipelines in EEG Lab.

    Measured: 4 weeks

  7. Changes from baseline in neurocognitive functioning (Repeatable Battery of Neuropsychological Status [RBANS])

    Neurocognitive performance will be assessed with the Repeatable Battery of Neuropsychological Status. Assessments will be completed at baseline (V1) and at post-treatment (V20).

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start18 Apr 2023
  3. Primary completion3 Jun 2024
  4. Study completion3 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This investigation is a one-way two-group between-subjects open-label design
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855850
Sponsor's protocol ID
15344
Status last verified
Jun 2024
First submitted
6 Feb 2023
Last updated
17 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Brainsway H4-Coil Deep TMS System and Brainsway H7-Coil Deep TMS System in people with Major Depressive Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility criteria 1: Protocol completion (time frame: 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.

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Deep rTMS for Depression in Older Adults (NCT05855850) | AzTrials