Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Repetitive Transcranial Magnetic Stimulation (rTMS): Eight rTMS sessions will be administer per day at 60-minute intervals for 5 consecutive days. Each rTMS session will consist of 600 pulses of theta-burst stimulation (iTBS), a pattern of 3 TMS pulses every 200 milliseconds for 2 seconds (i.e., 3 x 50 Hz bursts repeated at 5 Hz) for 3 minutes at 100% of resting motor threshold. The left dorsomedial prefrontal cortex (DMPFC) will be targeted via the Fz EEG site (30% of the nasion-inion distance posteriorly along the nasion-inion line).

Study summary

Grief is a normal response after the death of a loved one. With time, the grief response decreases and people learn to cope with their loss. However, for some, the response becomes more intense and distressing. This is called prolonged grief disorder (PGD). People with PGD experience emotional pain and a deep longing for their loved one. PGD normally occurs \<10% of people after a loss, but it has become more common since the COVID-19 pandemic (\~30%). If left untreated, PGD leads to poor quality of life and increased risk of death. Treatment options such as medication and therapy are available; however, they can cause negative side effects and take a long time to work. To help individuals with PGD, we need treatments that work well and quickly.

Repetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive treatment that delivers magnetic pulses to brain areas responsible for mood. rTMS has been approved in Canada to treat mood disorders. There is research to show that rTMS is safe and well-tolerated, and that works well in treating Post-Traumatic Stress Disorder (PTSD), a condition with similar symptoms to PGD. To determine whether rTMS is effective for treating PGD, we first need to determine if rTMS as a treatment for PGD is safe and feasible among grieving individuals.

Eligibility

Primary outcome measure(s)

• Recruitment Rate — Through study completion, up to 9 months
  Number of individuals recruited divided by the recruitment period
• Enrollment Rate — Through study completion, up to 9 months
  Number of individuals enrolled divided by the number of individuals approached
• Intervention Completion Rate — Through study completion, up to 10 months
  Number of participants who complete the intervention divided by the number of participants enrolled
• Withdrawal Rate — Through study completion, up to 16 months
  Number of participants who withdrew divided by the number of participants enrolled
• Follow-up Completion Rate — Through study completion, up to 16 months
  Number of participants who complete follow-up divided by the number of participants enrolled
• Number of Participants with Adverse Events — Through intervention completion, up to 1 week
  Proportion of participants who experience an adverse event

Trial sites (1)

More Bruyère Health Research Institute. trials in Canada