Accelerated Repetitive Transcranial Magnetic Stimulation for Apathy in Stroke Survivors A Double-Blind Randomized Controlled Trial

What this Trial Is About

Apathy, characterized by loss of motivation and withdrawal from activities, is common after stroke and significantly affects quality of life for survivors and their caregivers. This study investigates whether a new, accelerated form of repetitive transcranial magnetic stimulation rTMS targeting the medial prefrontal cortex mPFC can be safe and helpful for people experiencing apathy after stroke. The trial is a double-blind, randomized controlled phase III study focusing on improving apathy symptoms in chronic stroke survivors. Participants will be randomly assigned to receive either active accelerated intermittent theta burst stimulation iTBS rTMS targeting the left dorsal medial prefrontal cortex or a sham stimulation. The active treatment involves high-dose rTMS delivered in 12 sessions per day over six treatment days within two weeks, totaling 43,200 pulses. Sham treatment mimics the active procedure without delivering therapeutic stimulation. Brain imaging with MRI will help guide treatment targeting and will be performed before and immediately after the treatment period. During the study, participants will undergo clinical assessments at baseline, immediately after treatment, and one month post-treatment to measure changes in apathy symptoms, cognition, depression, and treatment acceptability. Researchers will monitor safety through treatment-emergent adverse events after each session. The primary outcome is the change in apathy measured by the Lille Apathy Rating Scale and the Apathy Evaluation Scale. The total participation duration includes treatment over two weeks and follow-up assessments up to one month post-treatment.

Accelerated rTMS vs. Sham for Stroke Apathy