rTMS Intervention Group for Depression and Anxiety

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression and Anxiety+3 Morerepetitive Transcranial Magnetic Stimulation (rTMS) - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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: Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. 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.

Eligible Conditions
  • Depression and Anxiety
  • Depression
  • Psychological Distress
  • End-Stage Disease

Treatment Effectiveness

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Upon study completion (up to 20 months)

Week 8
Change in Psychological Distress, Depression
Change in Psychological Distress, Depression and Anxiety
Month 3
Anxiety
Death Anxiety
Existential Distress
Participant Quality of Life: WHOQOL-Bref
Day 5
Completion of Intervention
Month 12
Recruitment Rate
Month 20
Completion of Follow-up

Trial Safety

Trial Design

1 Treatment Group

rTMS Intervention Group
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: rTMS Intervention Group · No Placebo Group · N/A

rTMS Intervention Group
Device
Experimental Group · 1 Intervention: repetitive Transcranial Magnetic Stimulation (rTMS) · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive Transcranial Magnetic Stimulation (rTMS)
2014
N/A
~450

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: upon study completion (up to 20 months)

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
529 Previous Clinical Trials
2,511,961 Total Patients Enrolled
Lotte & John Hecht Memorial FoundationOTHER
16 Previous Clinical Trials
4,886 Total Patients Enrolled
Bruyere Research InstituteOTHER
29 Previous Clinical Trials
2,019,990 Total Patients Enrolled
Canadian Cancer Society (CCS)OTHER
71 Previous Clinical Trials
30,884 Total Patients Enrolled
Bruyère Research InstituteUNKNOWN
1 Previous Clinical Trials
3,536 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References