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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

⁃ Age 18-80

• Visual acuity\>6 on Snellen visual acuity chart

⁃ Age 18-80

• Visual acuity\>6 on Snellen visual acuity chart

• Diagnosis of peripheral neuropathy

• Pain in lower limbs\>=3 cm on VAS scale

Locations
Other Locations
Switzerland
ETH Zurich
RECRUITING
Zurich
Contact Information
Primary
Stanisa Raspopovic, Prof. Dr.
stanisa.raspopovic@hest.ethz.ch
44 632 58 39
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 40
Treatments
Experimental: Virtual Reality and Transcutaneous Electrical Nerve Stimulation
for healthy subjects: painful stimulus induction (electrical stimulation) for patients: focus/non focus on pain~Therapy is released in presence of pain
Active_comparator: Virtual Reality only
only VR delivers therapy
Sponsors
Collaborators: Neural Control of Movement laboratory ETH Zurich
Leads: ETH Zurich

This content was sourced from clinicaltrials.gov