Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ETH Zurich
Zurich, Canton of Zurich, Switzerland, 8006
Actively Recruiting
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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