Using Transcranial Magnetic Stimulation to Alleviate Psychological Distress in Terminally Ill Patients
Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness: A Phase 2a/2b Dose-finding and Feasibility Clinical Trial
NA · Ottawa Hospital Research Institute · NCT04257227
This study is testing if a treatment called Transcranial Magnetic Stimulation can help relieve feelings of anxiety and depression in patients with advanced illnesses who are receiving palliative care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute (other) |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT04257227 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of repetitive Transcranial Magnetic Stimulation (rTMS) to alleviate psychological and existential distress in patients with advanced illness. It aims to identify effective dosing protocols for rTMS that can provide rapid relief from symptoms such as depression and anxiety, which are prevalent in this population. The study will involve patients receiving palliative care who score above a certain threshold for psychological distress. By exploring the feasibility and effectiveness of rTMS, the study seeks to offer a new therapeutic option for those facing end-of-life challenges.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced, terminal illnesses who are experiencing significant psychological distress and have a life expectancy of more than one month.
Not a fit: Patients with seizure disorders, certain brain conditions, or contraindications to rTMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients experiencing severe psychological distress at the end of life.
How similar studies have performed: While rTMS has shown promise in treating refractory depression, its application in palliative care settings for existential distress is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PC unit patients and PC patients in the community with advanced (terminal) illness * \>1 month life expectancy * Experiencing psychological distress, as indicated by a score of 7 or greater on the Depression, Anxiety, or Well-being subscale of the Edmonton Symptom Assessment System (ESAS) * Ability to understand and communicate in English Exclusion Criteria: * Current or previously diagnosed seizure disorder or first-degree relative with current or previously diagnosed seizure disorder * Documented brain lesions * Inability to remain still while sitting up (45 degrees) for the duration of therapy * Known contraindications to rTMS, including: metallic skull plates, clips, or stimulators; pacemakers and other electronic implants; pregnancy; recurrent headaches with no known cause that do not respond to over-the-counter medications; current or previous skull fracture or traumatic brain injury; previous brain surgery; medications that lower seizure threshold
Where this trial is running
Ottawa, Ontario
- Elisabeth Bruyère Hospital — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: James Downar, MDCM, MHSc
- Email: jdownar@toh.ca
- Phone: 6135626262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depressive Symptoms, Depression, Anxiety, Psychological Distress, Terminal Illness, palliative care, end of life, repetitive transcranial magnetic stimulation, dose-finding