Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches

According to the peripheral trigger theory of migraine headaches, nociceptive inputs from
irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain
that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral
trigger points can be administered to patients who have failed medical management of
migraines. Those accepted advanced treatments include botulinum toxin A injection in order to
temporarily paralyze muscles causing nerve compression, and surgery to release those
compression points permanently. An advantage of surgery is the ability to release
non-muscular causes of nerve compression, such as fascial bands or intersecting arteries.

Botulinum toxin A injection into trigger sites has been shown in multiple studies to be
effective at reducing the frequency and severity of migraine headaches, and is a very
commonly administered treatment for refractory migraines. It is approved by the FDA for the
treatment of chronic migraines.

Similarly, surgical decompression of trigger sites has previously been shown to have superior
clinical outcomes to medical management, through a randomized, blinded controlled-trial
performed at Case Western Reserve in 2009. Patients either received actual decompression of
the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without
decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a
statistically higher proportion with significant improvement in their migraines (83.7% vs.
57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p<0.001).
Several other reports have confirmed the good clinical outcomes of surgery demonstrated in
this trial, and surgical decompression is now commonly performed by several surgeons around
the United States.

Prognostic factors predicting the success of surgical decompression in migraine headache
treatment include older age of migraine onset, visual symptoms/aura, and 4-site
decompression. Factors predicting failure of surgery include excessive operative blood loss,
and surgery on only one or two trigger sites.

One criticism of the studies on peripheral trigger decompression surgery for migraines has
been that most of the results have originated from the same institution (Case Western
Reserve), and from the same author (Guyuron). While several studies at other institutions
have demonstrated positive outcomes of peripheral trigger decompression, these have only
included a small number of patients.

In addition, the sham surgery randomized-controlled trial has been criticized for not
clarifying any prior treatments that patients had undergone before peripheral trigger
deactivation, and for not showing how medication use patterns changed after surgery. Another
criticism of that study was the fact that patients were examined by neurologists before the
study but not after the study, and that surgery was performed on some patients with episodic
migraines, who are known to not benefit from botulinum toxin. It is unclear what migraine
types are most likely to benefit from surgical decompression.

The investigators' goal is to perform a multi-center, prospective trial to demonstrate the
effectiveness of peripheral trigger decompression in the treatment of migraine headaches,
which would address the criticisms mentioned above. The main aim is to demonstrate that the
positive results demonstrated by Guyuron et al are reproducible at other institutions and by
other surgeons using similar techniques on different patient populations.