MultiSENSory Stimulation to TArgeT Sensory Loss and ChronIc Pain in NeurOpathic PatieNts

Condition(s) studied

Investigational drug(s) / intervention(s)

VR+TENS: The subjects will receive a therapy that combines electrical pleasant stimulation of the nerves, synchronised with event in virtual reality

Study summary

Neuropathy is a costly and disabling health issue, which consists of a degeneration of the peripheral nerves. Even though the causes may be different, such as diabetes or amputation, the consequences for neuropathic patients are multiple and extremely debilitating. Among the alarming symptoms it implicates, chronic pain and sensory loss are among the most severe ones. Because of the loss of sensations, patients are forced to have an altered gait strategy, an impaired balance and a fivefold increased risk of falling. Furthermore, since they lose sensations and feel numbness in their extremity, they are discouraged in walking, hence leading to a sedentary lifestyle. All of this is worsened by the development of neuropathic pain, which has a high comorbidity with psychological issues, such as depression and anxiety.

Today, proper treatments for neuropathic pain that exclude pharmacological solutions are still missing. This is due to the complexity of the neurobiological mechanisms underlying the origin of neuropathy, the multifaceted physical and psychological nature of pain and the lack of reliable biomarkers.

The aim of this project is to tackle the major problems connected to neuropathy thanks to non-invasive stimulation of the peripheral nervous system. The system is composed of an insole with pressure sensors that captures in real time the force exerted by the subject on the foot and couples this information with parameters of electrical stimulation. Thanks to optimal electrode placement and intensity modulation, subjects are able to perceive in real-time in a somatotopic manner (i.e., under their foot) how they are walking. The aim now is twofold: first the investigators want to couple this stimulation with Virtual Reality (VR) to develop a neuroadaptive non-invasive brain computer interface (BCI) to treat pain and secondly the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain. Finally, the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain.

Eligibility

Primary outcome measure(s)

• Change in pain level — Through study completion, up to 10 days
  Change in pain level reported by the subjects, 10 cm Visual Analogue Scale (VAS) scale with anchor points 0 = No pain and 10 = Worst imaginable pain, Numerical Pain Rating Scale (NPRS), and the Neuropathic Pain Symptom Inventory (NPSI)
• Changes in brain activity and connectivity through functional Magnetic Resonance Imaging (fMRI) before and after the treatment — baseline and 1 week follow-up
  will be measured through functional Magnetic Resonance Imaging (fMRI) sessions
• Changes in brain activity and connectivity through functional Magnetic Resonance Imaging (fMRI) between somatotopic and non somatotopic stimulation at feet — baseline, pre-intervention
  The brain activity will be measured while stimulating the subjects in three different locations: 1.somatotopic 2. in-loco 3. at the ankle

Trial sites (1)

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