Focus of the Report: The use of the gammaCore (electroCore Medical LLC) noninvasive vagus nerve stimulator for the acute treatment or prevention of episodic and chronic cluster headaches (eCH and cCH).

Technology Description: The gammaCore stimulator is a small, portable, handheld device that delivers transcutaneous, noninvasive electrical stimulation to the vagus nerve (nVNS). This stimulation is thought to block the pain signals that contribute to cluster headache (CH).

Controversy: Treatment options for CH can be suboptimal in efficacy and can include risks, including dependence, or side effects such as fatigue, nausea, or vomiting. Potentially safer, nondrug therapies have been developed, including neuromodulation technologies that includes gammaCore nVNS. While the mechanisms for the therapeutic effects of vagus nerve stimulation are not fully understood, the basic premise is that stimulation of the vagus nerve can alter the activation of pain pathways and neuronal excitability in ways that reduce pain associated with a CH attack

Key Questions:

  • Is nVNS with gammaCore an effective acute treatment for eCH or cCH?

  • Is prophylactic nVNS with gammaCore effective in preventing CH attacks?

  • How does nVNS with gammaCore compare with alternative treatments for acute treatment or prevention of CH?

  • Is nVNS with gammaCore safe?

  • Have definitive patient selection criteria been identified for nVNS with gammaCore?

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