Abstract
Background: Fear memory extinction is closely related to insomnia. Repetitive transcranial magnetic stimulation (rTMS) is safe and effective for insomnia disorder (ID) and it has been shown an efficient method to modulate fear extinction. However, whether rTMS can improve fear extinction memory in ID patients remains to be studied. This study specifically aims to (1) 1-Hz rTMS stimulation could improve fear extinction memory of ID patients and (2) examine whether change in sleep mediates this impact.
Methods and design: We propose a parallel group randomized, double-blinded trial of 62 ID participants meeting criteria. Participants will be assigned to a real rTMS group or a sham rTMS group. The allocation ratio is 1:1, with 31 subjects in each group. Interventions will be administered five times per week over a 4-week period. Assessments will take place at baseline (week 0), post-intervention (week 4) and 8-week follow-up (week 8). The primary outcome measures of this study will be mean change scores of Pittsburgh Sleep Quality Index (PSQI). The secondary outcome measures include the mean change values of skin conductance responses (SCR), fear expectation during fear extinction, Insomnia Severity Index (ISI), Zung Self-Rating Anxiety Scale (SAS), and the Zung Self-Rating Depression Scale (SDS).
Discussion: This study will be the first examination of the impact of rTMS on fear memory extinction in ID patients.
Trial registration: Chinese Clinical Trials Register, ChiCTR2300076097. Registered on 25 September 2021.