Deep TMS for Depression and Cognitive Impairment in Older Adults

Overseen By Amanda Rahmadian, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rotman Research Institute at Baycrest

Must not be taking: Psychotropics, Antidepressants, Antipsychotics, others

Disqualifiers: Stroke, Epilepsy, Psychotic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

28 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants are stable on their medications for 2 months and do not change medications during the study. However, if you are taking certain psychotropic medications, including antidepressants, antipsychotics, or mood stabilizers, you may need to stop due to an increased risk of seizures.

What data supports the effectiveness of the treatment Brainsway H1-Coil Deep TMS System for depression and cognitive impairment in older adults?

Research shows that deep transcranial magnetic stimulation (TMS) using the H1 coil is effective in treating late-life depression, with a higher remission rate compared to a placebo treatment (40% vs 14.8%). It is also considered safe and well-tolerated, with no serious side effects reported. ^{1 2 3 4 5}

Is deep TMS safe for older adults with depression?

Deep TMS, including the Brainsway H1-Coil system, appears to be safe and well-tolerated in older adults with depression. Studies show no serious adverse events, though some participants reported mild pain during treatment. ^{1 3 6 7 8}

How is the Deep TMS treatment different from other treatments for depression in older adults?

Deep TMS (transcranial magnetic stimulation) is unique because it uses magnetic fields to stimulate specific areas of the brain, offering a non-drug alternative for depression, especially in older adults who may not tolerate medications well. It is administered through a device placed on the head, making it different from traditional treatments like medication or electroconvulsive therapy. ^{1 3 4 9 10}

What is the purpose of this trial?

In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.

Eligibility Criteria

This trial is for people over 60 with mild to early-moderate Alzheimer's or cognitive impairment and depression, who haven't done well with antidepressants. They must be stable on current meds, able to consent and follow the schedule, have a partner to help with questionnaires, and pass a safety screening for TMS.

Inclusion Criteria

I have been diagnosed with major depression for more than 4 weeks but less than 5 years.

Have a satisfactory safety screening questionnaire for TMS

Have an informant/study partner who is able to complete study questionnaires regarding the participant

Exclusion Criteria

I am taking medication for mental health that could increase my risk of seizures.

My family has a history of epilepsy.

Are a pregnant or breast-feeding woman

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily active dTMS treatment using the H1 coil for 4 consecutive weeks

4 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of emotional cognitive measures

4 weeks

1 visit (in-person)

Optional Extension

Participants may opt to receive 4 weeks of treatment using theta-burst TMS

4 weeks

Treatment Details

Interventions

• Brainsway H1-Coil Deep TMS System

Trial Overview The study tests deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil on deeper brain regions in older adults. It aims to see if this treatment can safely improve depression symptoms without changing other medications.

Participant Groups

Group I: Active H1 Coil deep rTMS active treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Rotman Research Institute at Baycrest

Lead Sponsor

Trials

11

Recruited

460+

Brainsway

Industry Sponsor

Trials

38

Recruited

2,800+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Findings from Research

In a pilot study involving 28 patients with treatment-resistant depression (TRD), accelerated deep transcranial magnetic stimulation (adTMS) showed significant reductions in depression scores, with a 59% decrease in Hamilton Depression Rating Scale (HDRS) scores after 10 days and 62% after 15 days.

The treatment was found to be safe, with only 9% of patients discontinuing due to adverse events, and 38% to 42% of patients achieving remission, indicating that adTMS could provide rapid clinical benefits and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot investigation of accelerated deep transcranial magnetic stimulation protocols in treatment-resistant depression. Filipčić, I., Šimunović Filipčić, I., Sučić, S., et al.[2022]

Transcranial magnetic stimulation (TMS) is shown to be safe for patients with major depressive disorder, with no significant increase in dropout rates or serious adverse events compared to sham treatment, based on a meta-analysis of 53 trials involving 3,273 participants.

While TMS may lead to some mild and transient non-serious adverse events like headaches and discomfort, these side effects are manageable, suggesting that TMS can be a viable treatment option either alone or alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. Wang, WL., Wang, SY., Hung, HY., et al.[2022]

In a study of 301 medication-free patients with treatment-resistant major depression, transcranial magnetic stimulation (TMS) significantly improved quality of life (QOL) and functional status compared to sham treatment during a 6-week trial.

The benefits of TMS were not only observed during the acute treatment phase but also sustained over a 24-week follow-up, indicating that TMS provides durable improvements in patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. Solvason, HB., Husain, M., Fitzgerald, PB., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability, and cognitive effects of deep transcranial magnetic stimulation for late-life depression: a prospective randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The effect of deep repetitive transcranial magnetic stimulation with an H1 coil on hopelessness in patients with major depressive disorder: A randomized controlled trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for treatment-resistant depression: Naturalistic treatment outcomes for younger versus older patients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Impact of transcranial magnetic stimulation on the symptom profile of major depressive episode. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

A pilot investigation of accelerated deep transcranial magnetic stimulation protocols in treatment-resistant depression. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Cognitive effects of 1- and 20-hertz repetitive transcranial magnetic stimulation in depression: preliminary report. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and benefits of distance-adjusted prefrontal transcranial magnetic stimulation in depressed patients 55-75 years of age: a pilot study. [2022]