Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness: A Phase 2a/2b Dose-finding and Feasibility Clinical Trial

What this Trial Is About

Patients with advanced illness often face psychological and existential distress, including depression and anxiety, which can lead to poor quality of life and increased desire for hastened death. Existing treatments for these symptoms are often slow to work or have significant side effects, making them challenging for patients nearing the end of life. Researchers are evaluating repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, as a potentially scalable and rapid treatment for psychological distress in this population. The study is designed in two phases: a phase 2a open-label dose-finding trial and a phase 2b randomized, sham-controlled or sham-crossover trial based on results from phase 2a. Participants receive rTMS treatment in a dedicated room on a palliative care unit while seated at a 45-degree angle or in a chair. The treatment involves stimulating the left dorsolateral prefrontal cortex using intermittent theta burst stimulation, with up to eight 3-minute sessions daily over five days. The phase 2b trial will compare active rTMS to a sham intervention to assess feasibility and preliminary efficacy. During the study, patients will be assessed for psychological distress, depression, anxiety, existential distress, death anxiety, and quality of life before, during, and after treatment at multiple time points up to several months. Recruitment and completion rates, patient satisfaction, and symptom changes will be closely monitored. Treatment intensity is personalized by measuring motor thresholds, and the study includes screening to exclude patients with contraindications to rTMS. Participation may last up to 20 months including follow-up assessments.

Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness