Controllable Pulse Parameter Transcranial Magnetic Stimulation in Fibromyalgia: A Randomized Control Study.

Abstract

Purpose: Controllable pulse parameter transcranial magnetic stimulation (cTMS) delivers monophasic pulses that may produce more robust and longer-lasting changes in corticospinal excitability compared to conventional biphasic stimulation. This study is the first to evaluate the efficacy of cTMS in individuals with fibromyalgia (FM).

Participants and methods: In this randomized, double-blinded, placebo-controlled study, 32 participants (48.6 ± 12.3 years, 2 M) completed ten sessions of cTMS or placebo stimulation over 2 weeks, targeting primary motor cortex (M1) using a 10 Hz monophasic protocol (2004 pulses). The primary outcome was pain intensity while secondary outcomes included quality of life (PROMIS-29 v2.0), step count, FM impact, mood, and corticospinal excitability.

Results: No significant differences between cTMS or placebo stimulation were observed for pain intensity or secondary outcomes. Exploratory within-group analyses identified a ~12% reduction in pain intensity, increased physical activity, as well as improvements in anxiety, depression, and PTSD symptoms following cTMS. However, these within-group changes were not significantly different from those observed in the placebo group.

Conclusion: Ten sessions of 10 Hz monophasic cTMS were well tolerated but did not demonstrate superiority over placebo for pain intensity or secondary outcomes in individuals with FM. The within-group improvements following cTMS support further investigation in larger and adequately powered studies to determine whether specific stimulation protocols or patient subgroups may benefit greater from monophasic stimulation.