NCT05483816: SENSATION

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

Recruiting now NA Last updated 18 November 2024

What this trial tests

NA trial testing VR+TENS in Neuropathy in 40 participants. Currently enrolling.

Timeline

30 June 2022

Primary endpoint
28 February 2026

28 February 2028

Quick facts

Lead sponsor	ETH Zurich
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	30 June 2022
Primary completion	28 February 2026
Estimated completion	28 February 2028
Sites	1 location across Switzerland

Drugs / interventions tested

• VR+TENS

Conditions studied

• Neuropathy — all drugs for Neuropathy →
• Neuropathy, Painful — all drugs for Neuropathy, Painful →
• Sensory Neuropathy — all drugs for Sensory Neuropathy →
• Diabetic Neuropathies — all drugs for Diabetic Neuropathies →

Sponsor

ETH Zurich — full company profile →

Who can join

Adults 18 to 80, any sex, with Neuropathy or Neuropathy, Painful. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brain-Computer Interface to Deliver Individualized Multisensory Intervention for Neuropathic Pain.
   Aurucci GV, Preatoni G, Damiani A, Raspopovic S. · · 2023 · cited 12× · PMID 37407726 · DOI 10.1007/s13311-023-01396-y
2. Wearable neuroprosthesis improves mobility and reduces pain in neuropathic participants
   Gozzi N, Chee L, Odermatt I, Kikkert S, et al · · 2024 · cited 3× · DOI 10.1101/2024.05.08.24306164
3. Targeted neural stimulation congruent with immersive reality decreases neuropathic pain – a Randomized Controlled Trial
   Aurucci GV, Gozzi N, Wagner M, Preatoni G, et al · · 2024 · DOI 10.1101/2024.12.10.24318374