Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBruyère Health Research Institute.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Bereaved individuals >/= 18 years of age
Score >25 on the Inventory of Complicated Grief
Must have a primary care physician
Ability to understand and communicate in English
Disqualifiers
Current or previously diagnosed seizure disorder
Documented brain lesions
Contraindications to TMS (i.e., metallic skull plates, clips, stimulators, pacemakers)
Current substance abuse disorder (e.g., schizophrenia)
Trial design
Design model
Single group
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceEight 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).
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: rTMS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Number of individuals recruited divided by the recruitment period
Time frame
Through study completion, up to 9 months2
Enrollment Rate
Number of individuals enrolled divided by the number of individuals approached
Time frame
Through study completion, up to 9 months3
Intervention Completion Rate
Number of participants who complete the intervention divided by the number of participants enrolled
Time frame
Through study completion, up to 10 months4
Withdrawal Rate
Number of participants who withdrew divided by the number of participants enrolled
Time frame
Through study completion, up to 16 monthsSecondary outcomes
1
Prolonged Grief Disorder - Global Impression of Change
Measured using the Patient Global Impression of Change (PGIC) scale (score 1-7 on one item; higher scores indicate greater positive change)
Time frame
Day 5 (last day of intervention), 2-week follow-up, 4-week follow-up, and monthly thereafter for up to 6 months2
Change in Prolonged Grief
Measured using the Inventory of Complicated Grief (ICG) (score 0-4 on each item; score of 26 or less or a score reduction of greater than or equal to 4 indicates therapeutic benefits)
Time frame
Baseline, day 5 (last day of intervention), 2-week follow-up, 4-week follow-up, and monthly thereafter for up to 6 months3
Prolonged Grief - Change in Post-Traumatic Stress
Measured using the Impact of Event Scale-Revised (IES-R) (score 0-4 on each item; score reduction of 4 indicates therapeutic benefit; score greater than 33 will be considered positive for PTSD)
Time frame
Baseline, day 5 (last day of intervention), 2-week follow-up, 4-week follow-up, and monthly thereafter for up to 6 months4
Prolonged Grief - Change in Depression
Measured using the Hamilton Depression Rating Scale (HDRS) (score 0-4 on each item; score reduction of 2 from baseline indicates therapeutic benefit)
Time frame
Baseline, day 5 (last day of intervention), 2-week follow-up, 4-week follow-up, and monthly thereafter for up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov