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

NCT05483816 | Recruiting

• 1 other identifier: NeuroengLab
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathy; Neuropathy, Painful; Sensory Neuropathy; Diabetic Neuropathies; Amputation

Outcome Measures

Primary Outcomes (3)

• Change in pain level

  Change in pain level reported by the subjects, 10 cm Visual Analogue Scale (VAS) scale with anchor points 0 = No pain and 10 = Worst imaginable pain, Numerical Pain Rating Scale (NPRS), and the Neuropathic Pain Symptom Inventory (NPSI)

  Through study completion, up to 10 days

• Changes in brain activity and connectivity through functional Magnetic Resonance Imaging (fMRI) before and after the treatment

  will be measured through functional Magnetic Resonance Imaging (fMRI) sessions

  baseline and 1 week follow-up

• Changes in brain activity and connectivity through functional Magnetic Resonance Imaging (fMRI) between somatotopic and non somatotopic stimulation at feet

  The brain activity will be measured while stimulating the subjects in three different locations: 1.somatotopic 2. in-loco 3. at the ankle

  baseline, pre-intervention

Secondary Outcomes (9)

• Changes in EEG

  Through study completion, up to 10 days

• Changes in Skin Conductance signatures

  Through study completion, up to 10 days

• Percentage of session completed

  post-intervention

• Changes in Anxiety and Depression

  baseline, post-intervention

• Changes in Quality of life

  baseline, post-intervention

Other Outcomes (3)

• Changes in Sensory assessment through Quantitative Sensory Testing (QST)

  baseline, during the intervention, post-intervention

• Changes in sensory acuity

  baseline, during the intervention, post-intervention

• Changes in reflex

  baseline, during the intervention, post-intervention

Study Arms (2)

Virtual Reality and Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

for healthy subjects: painful stimulus induction (electrical stimulation) for patients: focus/non focus on pain Therapy is released in presence of pain

Combination Product: VR+TENS

Virtual Reality only

ACTIVE COMPARATOR

only VR delivers therapy

Combination Product: VR+TENS

Interventions

VR+TENS COMBINATION_PRODUCT

The subjects will receive a therapy that combines electrical pleasant stimulation of the nerves, synchronised with event in virtual reality

Virtual Reality and Transcutaneous Electrical Nerve Stimulation; Virtual Reality only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Visual acuity\>6 on Snellen visual acuity chart

You may not qualify if:

• Pregnancy
• Cognitive deficits (Mini Mental State Examination\<23)
• Cyber-sickness
• Prior or current psychological diseases
• Pacemakers
• Epilepsy
• Claustrophobia
• Other MRI contraindications
• Unhealed fractures
• Unhealed wounds
• Cancerous growth in proximity to feet
• Swollen, infected or inflamed areas on feet or skin eruptions on feet such as phlebitis, thrombophlebitis or varicose veins
• for patients:
• Age 18-80
• Visual acuity\>6 on Snellen visual acuity chart

Sponsors & Collaborators

• ETH Zurich: lead
• Neural Control of Movement laboratory ETH Zurich: collaborator

Study Sites (1)

ETH Zurich

Zurich, Canton of Zurich, 8006, Switzerland

RECRUITING

MeSH Terms

Conditions

Neuropathy, Painful; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Stanisa Raspopovic, Prof. Dr.

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanisa Raspopovic, Prof. Dr.

CONTACT

44 632 58 39; stanisa.raspopovic@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Stanisa Raspopovic

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 2, 2022
• Study Start: June 30, 2022
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)