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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how deep repetitive transcranial magnetic stimulation (rTMS) might benefit older adults with mild to early-moderate Alzheimer's disease and major depression who haven't found relief with antidepressants. rTMS uses magnets to stimulate specific brain areas. The goal is to determine if this can improve symptoms of depression and cognitive issues. This trial may suit individuals over 60 with both Alzheimer's and depression who have not responded to or tolerated antidepressants. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

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 prior data suggests that this device is safe for older adults with depression and cognitive impairment?

Research has shown that deep transcranial magnetic stimulation (TMS) using the H1 coil is generally safe for treating depression. Studies have found that this treatment is well-tolerated, even for individuals who haven't responded to antidepressant medications. For instance, one study found that patients with major depressive disorder (MDD) who received H1 coil deep TMS did not experience significant side effects. Another study indicated that deep TMS is a safe option for both teenagers and young adults with depression.

Although these studies focus on different age groups, they suggest that the treatment is generally safe. Importantly, the H1 coil has been used for various conditions, and no major safety concerns have been reported. Therefore, for older adults with depression and cognitive issues, the treatment is expected to be safe and tolerable based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brainsway H1-Coil Deep TMS System because it offers a novel approach to addressing depression and cognitive impairment in older adults. Unlike traditional antidepressants and cognitive therapy, which can take weeks to show effects, deep transcranial magnetic stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain, potentially offering faster results. Additionally, TMS is non-invasive and does not involve medication, making it an appealing option for those who are sensitive to pharmaceutical treatments or have not responded well to other therapies. This cutting-edge technique targets specific brain regions associated with mood regulation and cognitive function, offering hope for improved outcomes in a population often underserved by current treatments.

What evidence suggests that the Brainsway H1-Coil Deep TMS System is effective for depression and cognitive impairment in older adults?

Research has shown that Deep TMS with the H1 coil, which participants in this trial will receive, can effectively treat depression. Studies have found that symptoms often improve within 20 treatment sessions, even for older adults with mild memory problems or early Alzheimer's disease. The treatment has also proven effective in everyday settings, not just in controlled clinical trials. For those dealing with both depression and memory issues, this approach could offer significant benefits. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Are a pregnant or breast-feeding woman

My family has a history of epilepsy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37030054/

Deep TMS H1 Coil treatment for depression: Results from a ... This study shows that beyond its proven efficacy in RCTs, Deep TMS with the H1 coil is effective for treating depression under naturalistic conditions.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123001300

Deep TMS H1 Coil treatment for depression This study shows that beyond its proven efficacy in RCTs, Deep TMS with the H1 coil is effective for treating depression under naturalistic conditions.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03665831

Deep TMS for Comorbid Depression and Cognitive ... This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age ...

4. brainsway.com brainsway.com/knowledge-center/deep-tms-h1-coil-treatment-for-depression-results-from-a-large-post-marketing-data-analysis/

Deep TMS H1 Coil treatment for depression Deep TMS with the H1 coil is effective for treating depression under naturalistic conditions, and the onset of improvement is usually within 20 sessions.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35207288/

Efficacy of Deep TMS with the H1 Coil for Anxious ... Deep TMS is effective in treating comorbid anxiety in MDD and, unlike alternative treatments, the outcome does not appear to be adversely affected by high ...

6. brainsway.com brainsway.com/knowledge-center/cognitive-outcomes-of-tms-treatment-in-bipolar-depression-safety-data-from-a-randomized-controlled-trial/

Cognitive Outcomes of Bipolar TMS Treatment: Safety Data In this study, the investigators evaluated the cognitive effects of H1-coil (deep) transcranial magnetic stimulation(TMS) in patients with treatment-resistant ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4329899/

Efficacy and safety of deep transcranial magnetic ... These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S016517812500215X

Safety and efficacy of Deep TMS for adolescent depression ... Deep TMS is a safe and effective therapeutic option for adolescents and young adults suffering from MDD when delivered under routine outpatient treatment ...