Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT05483816

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

Led by ETH Zurich · Updated on 2024-11-18

40

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

E

ETH Zurich

Lead Sponsor

N

Neural Control of Movement laboratory ETH Zurich

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Visual acuity greater than 6 on Snellen visual acuity chart
  • For patients: diagnosis of peripheral neuropathy
  • For patients: pain in lower limbs of at least 3 on Visual Analog Scale
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Cognitive deficits (Mini Mental State Examination score less than 23)
  • Cyber-sickness
  • Prior or current psychological diseases
  • Presence of pacemakers
  • Epilepsy
  • Claustrophobia
  • Other contraindications for MRI
  • Unhealed fractures
  • Unhealed wounds
  • Cancerous growth near the feet
  • Swollen, infected, or inflamed areas on feet or skin eruptions such as phlebitis, thrombophlebitis, or varicose veins
  • For patients: relevant comorbidities affecting study outcomes (per physician judgment)
  • For patients: presence of ulcers

AI-Screening

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Trial Site Locations

Total: 1 location

1

ETH Zurich

Zurich, Canton of Zurich, Switzerland, 8006

Actively Recruiting

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Research Team

S

Stanisa Raspopovic, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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