Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05483816
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-14
Brief Title:
multiSENSory Stimulation to tArgeT Sensory Loss and chronIc Pain in neurOpathic patieNts
Sponsor:
ETH Zurich
Organization:
ETH Zurich
Study Overview
Official Title:
multiSENSory Stimulation to tArgeT Sensory Loss and chronIc Pain in neurOpathic patieNts
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSATION
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 ie 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
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 ie 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
Detailed Description:
One of the notoriously hardest and long-established challenges for the whole scientific community concerns the complete understanding and consequently the treatment of neuropathy This condition results in an altered gait strategy an impaired balance and a fivefold increased risk of falling Falling is one of the major health-related problems In the United Kingdom more than one fourth of accidents requiring hospital treatment are a consequence of falls Furthermore since they lose sensations and feel numbness in their extremity they are discouraged in walking hence leading to a sedentary lifestyle which promotes other long-term complications eg of the cardiovascular system This has also very severe impacts on the patients psychological health Indeed the comorbidity of neuropathy with anxiety and depression has been estimated to be 59 in the US population Patients may develop neuropathic pain associable to the aberrant sensory inputs Experiencing pain impacts even more on gait stability and on the fear of falling Given the complexity of the underlying mechanisms chronic neuropathic pain is one of the most prevalent costly and disabling health issue hitting a huge portion of the world population Chronic pain indeed is estimated to affect approximately 19 of the adult European population Nowadays current chronic pain therapies either behavioural pharmacological or surgical are inefficient as demonstrated by the high prevalence low rates of functional recovery and the assiduous reliance on opioid analgesics
The reasons of such lack of efficacy can be attributed to different factors among which the lack of therapies addressing the multidimensions of pain as pain is not a unitary phenomenon rather a multidimensional outcome of sensory-discriminative and motivational-affective components that should be synergistically accounted for and the lack of reliable biomarkers objective indicators of pain are needed to demonstrate therapeutic target engagement to stratify patients and to predict disease progression or therapeutic responses
These factors are the main focuses of this study whose aim is to develop a multisensory platform for pain detecting pain through physiological recordings and delivering a therapy when such physiological biomarkers are detected First the detection of pain is exploited through electrophysiology and then the therapy is delivered by means of Virtual Reality VR and Transcutaneous Electrical Nerve Stimulation TENS in order to target both physiological and affectivecognitive components of neuropathic pain VR and TENS have already singularly produced encouraging results in literature26-29 However these results are conflicting and not conclusive The investigators believe that the combination of these technologies which targets all the different aspects of pain will really provide a successful and lasting benefit to the patients chronic pain
Furthermore the nature of the platform which includes the use of non-invasive electrical stimulation allows to recreate sensations in parts of the body where the subjects dont feel sensations anymore Indeed thanks to years of research the Neuro-engineering laboratory found optimal stimulation parameters and electrode placement which are able to elicit sensations far from the electrodes placement Electrodes are indeed placed on healthy parts of the nerves but the perceived sensation is in the extremities This allows to target also another extremely common consequence of neuropathy sensory loss This symptom forces patients to have an altered gait strategy impaired balance and a five-fold increased risk of falling Therefore in this study the investigators will monitor also the potential benefits of the platform on these aspects
As for the imaging sessions before starting the imaging sessions patients will be assessed to obtain potential information that might impact on the results
Healthy participants and patients will be asked to participate in two-three fMRI sessions Prior to the scanning a calibration procedure will take place to understand the subjects stimulation parameters and characterize the location and type of sensations elicited
During the fMRI sessions the investigators will examine the neural correlates of the referred perceptions and any pain relief induced using the non-invasive TENS stimulation approach During these sessions different types of stimulations will be performed with the TENS stimulation system with vibrotactile stimulators and with visual stimulations Resting state fMRI will be used to examine functional connectivity between different regions of interest Each fMRI session will last 70-80 minutes
The reasons of such lack of efficacy can be attributed to different factors among which the lack of therapies addressing the multidimensions of pain as pain is not a unitary phenomenon rather a multidimensional outcome of sensory-discriminative and motivational-affective components that should be synergistically accounted for and the lack of reliable biomarkers objective indicators of pain are needed to demonstrate therapeutic target engagement to stratify patients and to predict disease progression or therapeutic responses
These factors are the main focuses of this study whose aim is to develop a multisensory platform for pain detecting pain through physiological recordings and delivering a therapy when such physiological biomarkers are detected First the detection of pain is exploited through electrophysiology and then the therapy is delivered by means of Virtual Reality VR and Transcutaneous Electrical Nerve Stimulation TENS in order to target both physiological and affectivecognitive components of neuropathic pain VR and TENS have already singularly produced encouraging results in literature26-29 However these results are conflicting and not conclusive The investigators believe that the combination of these technologies which targets all the different aspects of pain will really provide a successful and lasting benefit to the patients chronic pain
Furthermore the nature of the platform which includes the use of non-invasive electrical stimulation allows to recreate sensations in parts of the body where the subjects dont feel sensations anymore Indeed thanks to years of research the Neuro-engineering laboratory found optimal stimulation parameters and electrode placement which are able to elicit sensations far from the electrodes placement Electrodes are indeed placed on healthy parts of the nerves but the perceived sensation is in the extremities This allows to target also another extremely common consequence of neuropathy sensory loss This symptom forces patients to have an altered gait strategy impaired balance and a five-fold increased risk of falling Therefore in this study the investigators will monitor also the potential benefits of the platform on these aspects
As for the imaging sessions before starting the imaging sessions patients will be assessed to obtain potential information that might impact on the results
Healthy participants and patients will be asked to participate in two-three fMRI sessions Prior to the scanning a calibration procedure will take place to understand the subjects stimulation parameters and characterize the location and type of sensations elicited
During the fMRI sessions the investigators will examine the neural correlates of the referred perceptions and any pain relief induced using the non-invasive TENS stimulation approach During these sessions different types of stimulations will be performed with the TENS stimulation system with vibrotactile stimulators and with visual stimulations Resting state fMRI will be used to examine functional connectivity between different regions of interest Each fMRI session will last 70-80 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None