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

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).

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.

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.

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.