Personalized Auricular Vagus Nerve Stimulation in Intractable Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      One in five people in the general adult population suffer from chronic pain, a figure that is
      higher than heart disease, cancer, and diabetes combined. A majority of these patients is
      suffering from chronic back pain. Conventional treatment options offer only a partial
      response, with many people continuing to suffer severe chronic pain, despite receiving
      several treatments.

      Non-pharmacological treatments by neuromodulation represent a promising treatment modality
      for these patients. For instance, spinal cord stimulation blocks pain signals travelling to
      the brain, but requires implantation near the spine with significant clinical risks. Vagus
      nerve stimulation (VNS) is another neuromodulation modality proposed to alleviate chronic
      pain. Conventional VNS devices are implanted under the skin on the chest and the electrodes
      are wired to the left vagus nerve in the neck. However, aside from implantation risks, VNS is
      often associated with side effects such as swallowing difficulties, due to unwanted
      stimulation of motoric vagus nerve branches in the neck.

      Percutaneous auricular VNS (pVNS) is an emerging technology for stimulation of the auricular
      branch of the vagus nerve in the pinna of the ear. Specific electrical impulses are applied
      via three miniature needle electrodes located in the auricle near sensory vagus nerve fibers.
      Scientific data show that pVNS modulates brain circuits involved in autonomic control and
      pain processing. pVNS has shown positive effects in chronic low-back pain patients, in a
      sustainable way with a low side-effect profile. However, the optimal settings of stimulation
      with regards to personalization remain to be elucidated.

      The present prospective, open, randomized, controlled pilot study aims at evaluating the
      performance of pVNS treatment, using a small wearable stimulation device (AuriMod CT01),
      comparing personalized and non-personalized stimulation paradigms in patients with chronic
      low-back pain. Patients will be randomized in one of the following treatment groups (1) Group
      A: Stimulation with personalized stimulation parameters and amplitude, (2) Group B:
      Stimulation with personalized stimulation amplitude, (3) Group C: Stimulation without
      personalization (comparator group).

      Patients will be treated for 8 weeks. Patients will receive standardized pain medication
      including rescue medication in parallel. An additional follow-up period of 12 weeks allows to
      evaluate sustainable and late-time effects of treatment. Patients will use a therapy
      management system to monitor outcome.
    


Intervention name(s): AuriMod CT01_A; AuriMod CT01_B; AuriMod CT01_C
Intervention type(s): Device; Device; Device
Intervention description(s): AuriMod CT01 is a wearable medical device for personalised pain treatment through auricular vagus nerve stimulation. AuriMod CT01 is a battery-operated electrical stimulation device, to be placed behind the ear on the neck. AuriMod CT01 connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electrical signals with a personalized set of stimulation parameters and adjustable amplitude.; AuriMod CT01 with a fixed set of stimulation parameters and adjustable stimulation amplitude.; AuriMod CT01 with a fixed set of stimulation parameters and amplitude.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vagus Nerve Stimulation; Personalization; Therapy Management