Recruiting

rTMS

Sponsor:

Bruyère Health Research Institute.

Code:

NCT06953596

Conditions

Prolonged Grief Disorder

Complicated Grief

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

Brief 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.

Conditions

Prolonged Grief Disorder

Complicated Grief

Study ID

NCT06953596

Start date

Nov 28, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Bereaved individuals >/= 18 years of age
2. Score >25 on the Inventory of Complicated Grief
3. Must have a primary care physician
4. Ability to understand and communicate in English
5. Ability to provide first-person informed consent

Exclusion Criteria:

1. Current or previously diagnosed seizure disorder
2. Documented brain lesions
3. Contraindications to TMS (i.e., metallic skull plates, clips, stimulators, pacemakers)
4. Current substance abuse disorder (e.g., schizophrenia)
5. Pregnancy or lactation, or trying to conceive
6. Advanced, incurable illness with an expected prognosis of <3 months - bereaved family members are known to be at elevated risk of death from medical illness, but if death is expected in the near future, it would be difficult to justify using an entire week of their limited time for an unproven therapy.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rTMS Intervention

Interventions

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).

Primary outcome measure

  • Recruitment Rate [ Time Frame: Through study completion, up to 9 months ]
  • Enrollment Rate [ Time Frame: Through study completion, up to 9 months ]
  • Intervention Completion Rate [ Time Frame: Through study completion, up to 10 months ]
  • Withdrawal Rate [ Time Frame: Through study completion, up to 16 months ]
  • Follow-up Completion Rate [ Time Frame: Through study completion, up to 16 months ]
  • Number of Participants with Adverse Events [ Time Frame: Through intervention completion, up to 1 week ]

Central Contacts and Locations

Central contacts

James Downar, MDCM, MHSc

613-562-6262jdownar@toh.ca

Locations

Bruyere Health

Recruiting

Ottawa, Ontario, Canada, K1R 7A5

Contacts

James Downar, MDCM, MHSc

613-562-6262jdownar@toh.ca

Principal Investigator:

James Downar, MDCM, MHSc

More Information

Sponsor

Bruyère Health Research Institute.

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Neuromodulation
  • Repetitive Transcranial Magnetic Stimulation
  • Bereavement
  • Proof-of-Concept
  • Feasibility
  • Intermittent Theta Burst Stimulation (iTBS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bruyère Health Research Institute. on 2026-07-10.