Transcranial Magnetic Stimulation for Prolonged Grief Disorder

Overseen By Nadia Polskaia, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bruyere Research Institute

Disqualifiers: Seizure disorder, Brain lesions, Substance abuse, others

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

Compensation: Varies

Number of Visits: 5

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called repetitive transcranial magnetic stimulation (rTMS) to determine its effectiveness for people with prolonged grief disorder (PGD), a condition where intense grief persists much longer than usual. rTMS is a non-invasive procedure that uses magnetic pulses to target brain areas involved in mood and has shown promise in treating related mood disorders. The trial aims to assess the safety and practicality of rTMS for those experiencing PGD. Suitable candidates for this trial are individuals who have been grieving intensely, find it hard to cope after losing a loved one, and have a primary care doctor. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for PGD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for treating prolonged grief disorder?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is a safe and well-tolerated treatment. This non-invasive technique uses magnetic pulses to target brain areas involved in mood. Studies have demonstrated its effectiveness for mood disorders, and it has been approved for this use in Canada since 2002. Additionally, rTMS is used for conditions similar to prolonged grief disorder, such as PTSD (post-traumatic stress disorder), without major safety concerns.

A review of rTMS safety found it generally safe for various conditions, suggesting it might also be safe for treating prolonged grief disorder. This trial specifically aims to test its safety for individuals who are grieving. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it offers a non-invasive approach to treating Prolonged Grief Disorder. While most traditional treatments for this condition involve psychotherapy or medication like antidepressants, rTMS uses magnetic fields to stimulate nerve cells in the brain, potentially affecting mood regulation and emotional processing. Researchers are excited about rTMS because it targets specific brain regions without the systemic side effects associated with medications, offering hope for faster relief and improved outcomes for patients.

What evidence suggests that repetitive transcranial magnetic stimulation is effective for prolonged grief disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial will receive, is a safe and well-tolerated treatment. Studies have found it effective for conditions like Post-Traumatic Stress Disorder (PTSD), which shares symptoms with prolonged grief disorder (PGD). In some studies, rTMS led to small improvements in depression scores compared to a sham (fake) treatment. These findings suggest rTMS might help reduce the intense emotional pain and longing experienced by people with PGD. While more research is needed specifically for PGD, the positive results in similar conditions are encouraging. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing prolonged grief disorder (PGD), which is intense emotional pain and longing after losing a loved one. It's more common since COVID-19, affecting about 30% of grieving people. Participants should have PGD symptoms that significantly impact their life.

Inclusion Criteria

Score greater than 25 on the Inventory of Complicated Grief

Must have a primary care physician

Ability to understand and communicate in English

Exclusion Criteria

Pregnancy or lactation, or trying to conceive

Contraindications to TMS (i.e., metallic skull plates, clips, stimulators, pacemakers)

Current substance abuse disorder (e.g., schizophrenia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) to treat prolonged grief disorder

5 days

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Monthly visits

Long-term Follow-up

Participants are monitored for long-term safety and efficacy outcomes

Up to 16 months

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The trial tests repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive treatment using magnetic pulses on the brain to improve mood. It's already used for mood disorders in Canada and may help with PGD by targeting similar brain areas as those affected in PTSD.

How Is the Trial Designed?

Group I: rTMS Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bruyere Research Institute

Lead Sponsor

Trials

35

Recruited

2,024,000+

Bruyère Health Research Institute.

Lead Sponsor

Published Research Related to This Trial

In a study involving 20 patients with unipolar depression, the pain associated with left prefrontal repetitive transcranial magnetic stimulation (rTMS) decreased by 48% over 15 treatment sessions, indicating that discomfort may lessen with continued use.

The reduction in pain was most significant in the first few days but continued steadily throughout the treatment, suggesting that patients may tolerate rTMS better over time, which could encourage ongoing treatment despite initial discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing procedural pain over time of left prefrontal rTMS for depression: initial results from the open-label phase of a multi-site trial (OPT-TMS). Anderson, BS., Kavanagh, K., Borckardt, JJ., et al.[2021]

Transcranial magnetic stimulation (TMS) is a non-invasive technique that can modulate brain activity and has shown potential as a treatment for major depression, with a meta-analysis indicating robust statistical effects, although individual responses can vary widely.

While TMS has demonstrated antidepressant properties, the overall rates of clinical response and remission are limited, and the long-term effectiveness of TMS treatments remains largely unknown.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric applications of transcranial magnetic stimulation: a meta analysis. Burt, T., Lisanby, SH., Sackeim, HA.[2019]

In a study of 15 medication-free subjects with major depression, 10 sessions of repetitive transcranial magnetic stimulation (rTMS) did not significantly reduce depression severity compared to sham treatment, indicating limited efficacy in this short-term application.

However, patients with a shorter duration of depressive episodes (less than 4 years) experienced a much greater response to rTMS, suggesting that treatment timing may be crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shorter duration of depressive episode may predict response to repetitive transcranial magnetic stimulation. Holtzheimer, PE., Russo, J., Claypoole, KH., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) showed a statistically significant but small improvement in depression scores compared to sham treatment, with a weighted mean difference of 2.31 points, which is below the clinically important threshold of 3.5 points.

In comparison to electroconvulsive therapy (ECT), rTMS was less effective, with ECT showing a greater improvement in depression scores and higher rates of remission and response, indicating that ECT may be a more effective option for treatment-resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

Repetitive transcranial magnetic stimulation (rTMS) has been shown to be a safe and effective treatment for major depressive disorder (MDD), supported by multiple randomized controlled trials and extensive literature review.

The consensus recommendations from a group of 17 expert clinicians and researchers provide detailed guidance on the clinical application of rTMS, ensuring its safe and effective use in treating MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. McClintock, SM., Reti, IM., Carpenter, LL., et al.[2022]

Transcranial magnetic stimulation (TMS), particularly repetitive TMS (rTMS), is a safe and effective non-invasive brain stimulation technique that has been shown to induce long-lasting neuroplastic effects, making it a promising treatment for conditions like treatment-resistant depression (TRD) and other psychiatric disorders.

rTMS has received regulatory approval for various conditions, including TRD, anxiety disorders, obsessive-compulsive disorder, and substance use disorders, with ongoing research suggesting its potential for treating additional psychiatric issues such as schizophrenia and post-traumatic stress disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory Clearance and Approval of Therapeutic Protocols of Transcranial Magnetic Stimulation for Psychiatric Disorders. Cotovio, G., Ventura, F., Rodrigues da Silva, D., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) significantly improves treatment-resistant depression, showing over three times higher odds of response compared to sham treatments, and nearly three times higher odds of achieving remission.

rTMS also effectively reduces symptoms of obsessive-compulsive disorder (OCD) and negative symptoms of schizophrenia, although it does not significantly impact auditory hallucinations, indicating varying efficacy based on the specific psychiatric condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depression, Schizophrenia, and Obsessive-Compulsive Disorder: An Umbrella Meta-Analysis. Patel, S., Silvi, S., Desai, S., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Transcranial magnetic stimulation (TMS) is an FDA-approved, noninvasive treatment for major depressive disorder, with response rates of 40%-60% in treatment-resistant cases, indicating its efficacy in improving mood and brain function.

TMS is generally safe and well tolerated, with the rarest serious risk being seizure, making it a low-risk option for patients seeking alternatives to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric Applications of Repetitive Transcranial Magnetic Stimulation. Marder, KG., Barbour, T., Ferber, S., et al.[2023]

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