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
104 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 causes degeneration of peripheral nerves leading to chronic pain, sensory loss, altered walking, impaired balance, and increased risk of falling. This condition also often results in reduced physical activity and psychological issues like depression and anxiety. Current treatments excluding drugs are lacking due to the complex neurobiology and absence of reliable pain biomarkers. This study aims to address these challenges by developing a multisensory platform combining sensory feedback and therapy to treat neuropathic pain and sensory loss. The study evaluates a non-invasive system using an insole with pressure sensors and electrical stimulation to provide real-time sensory feedback during walking. It combines Virtual Reality (VR) and Transcutaneous Electrical Nerve Stimulation (TENS) to target both physiological and psychological aspects of neuropathic pain. Two groups receive either VR combined with TENS or VR alone. The study includes calibration, multiple fMRI sessions, and different stimulation types to assess brain changes and pain relief. Participants will undergo assessments including fMRI scans lasting about 70-80 minutes, calibration of stimulation parameters, and physiological recordings such as EEG and skin conductance. Measurements include pain levels, brain activity, anxiety, depression, quality of life, balance, gait speed, and walking tests. The study monitors potential brain plasticity changes and therapy effects over up to 10 days, with follow-up assessments one week after treatment.
CONDITIONS
Brief Title
MultiSENSory Stimulation to TArgeT Sensory Loss and ChronIc Pain in NeurOpathic PatieNts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 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 3 or higher on the Visual Analog Scale (VAS)
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 the feet or skin eruptions such as phlebitis, thrombophlebitis, or varicose veins
- For patients: relevant comorbidities affecting study outcomes (as judged by physicians)
- For patients: presence of ulcers on the feet or lower limbs
- For healthy participants: visual acuity less than or equal to 6 on Snellen chart
- For healthy participants: not meeting age criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants receive therapy combining electrical nerve stimulation and virtual reality to target chronic neuropathic pain and sensory loss.
Daily visits for up to 10 days
Duration - During and shortly after treatment up to 1 week follow-up
Participants undergo 2 to 3 fMRI sessions including calibration and different types of stimulation to assess brain activity and connectivity related to pain and therapy effects.
2 to 3 fMRI sessions lasting approximately 70 to 80 minutes each
Duration - Up to 1 week post-treatment
Participants are monitored for changes in pain, brain activity, anxiety, depression, quality of life, balance, and gait after completing treatment.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
ETH Zurich
Zurich, Canton of Zurich, Switzerland, 8006
Actively Recruiting
Research Team
S
Stanisa Raspopovic, Prof. Dr.
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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