NCT04257227 Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness
| NCT ID | NCT04257227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-11-02 |
| Primary Completion | 2025-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2020-11-02 with a primary completion date of 2025-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Psychological and existential distress are a common cause of suffering among patients nearing the end of life, and a major reason for requesting medical aid in dying. Existing treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. There is a need to develop scalable, brief, and rapidly effective therapeutic approaches that can reduce psychological and existential distress in patients nearing the end of life. Repetitive Transcranial Magnetic Stimulation is an effective treatment for refractory depression, and new protocols and increasing availability of rTMS may make this therapy feasible and acceptable for patients who suffer from psychological or existential distress near the end of life. Among patients with advanced illness followed by a PC provider, the study objectives are to: 1. Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. 2. Test the feasibility and preliminary efficacy of rTMS for the treatment of psychological distress including: 1) ease of recruitment; 2) completion of follow-up; 3) effect size and variance estimates of treatment for primary and secondary outcomes; and 4) patient satisfaction with treatment. This study is a phase 2a dose-finding open-label clinical trial, followed by a phase 2b prospective, sham-control or sham-crossover study, depending on the therapeutic dose identified in phase 2a. The investigators will enroll eligible patients from an inpatient palliative care unit and administer rTMS according to established best practice international guidelines. Two screening tests will be conducted (one completed by patient and another by the treating physician) to ensure the patient has no contraindications to rTMS. In the open-label dose-finding study, investigators will determine the appropriate dose of treatment that leads to positive patient outcomes, assess characteristics associated with positive and rapid response to rTMS, and examine if this treatment is feasible and acceptable to patients by measuring rates of enrollment and completion of the treatment sessions. Based on results from this first phase, a phase 2b feasibility and preliminary efficacy randomized clinical trial will be conducted to measure the effect of rTMS by comparing patient symptoms before and after the rTMS intervention.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04257227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04257227 currently recruiting?
Yes, NCT04257227 is actively recruiting participants. Contact the research team at jdownar@toh.ca for enrollment information.
Where is the NCT04257227 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT04257227 clinical trial?
NCT04257227 is sponsored by Ottawa Hospital Research Institute. The trial plans to enroll 15 participants.