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

ConditionsNeuropathy Neuropathy, Painful Sensory Neuropathy Diabetic Neuropathies Amputation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorETH Zurich

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-80

Visual acuity>6 on Snellen visual acuity chart

Pregnancy

Cognitive deficits (Mini Mental State Examination<23)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Virtual Reality and Transcutaneous Electrical Nerve StimulationExperimental treatment 1 intervention

Group B: Virtual Reality onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

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

Time frame

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

Time frame

baseline, pre-intervention

Secondary outcomes

Changes in EEG

EEG: electroencephalography is a non-invasive measure. A cap is placed on the subject's head and detects the brain activity. In order to do so, a conduction gel (washable with water) is placed on each electrode. We will measure: general Power Spectral Density, frequency bands power (delta, theta, alpha, beta, gamma), connectivity, phase locking value, entropy.

Time frame

Through study completion, up to 10 days

Changes in Skin Conductance signatures

Skin Conductance (SC): skin conductance is a measure of the electrodermal activity. It is measured through a couple of non invasive electrodes on the palm of the patient. We will extract features such as peak amplitude, latency, variation, derivative.

Time frame

Through study completion, up to 10 days

Percentage of session completed

Compliance = % of each session completed.

Time frame

post-intervention

Changes in Anxiety and Depression

measured through validated questionnaires: Beck Anxiety Inventory and Beck Depression inventory

Time frame

baseline, post-intervention

Other outcomes

Changes in Sensory assessment through Quantitative Sensory Testing (QST)

QST: quantitative sensory testing is a set of measurements that measure the sensitivity of subjects. The include: light touch, vibration, hot and cold.

Time frame

baseline, during the intervention, post-intervention

Changes in sensory acuity

Sensory discrimination: an object with two extremities distant from 2 to 60 mm are placed on the subject's tested area and the subjects are asked to rate whether they feel 1 or 2 points.

Time frame

baseline, during the intervention, post-intervention

Changes in reflex

Reflexes: the ability to have intact reflexes corresponds to healthy nerves. Of particular interest will be the H reflex, where the tibial nerve is stimulated behind the knee and the reflex is measured through electromyography at the calf. We will measure it's latency, amplitude and ratio between M wave and H reflex

Time frame

baseline, during the intervention, post-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ETH Zurich

Lead sponsor

Neural Control of Movement laboratory ETH Zurich

Collaborator

Source ClinicalTrials.gov

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