Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785001
Status:
RECRUITING
Last Update Posted:
2023-02-17
First Post:
2021-01-26
Brief Title:
New Markers to Assess the Efficacity of Spinal Cord Stimulation for the Treatment of Chronic Lower Limb Pain MOTIVE
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Assessment of New Physiological Radiological and Activity Markers in Patients Treated by Spinal Cord Stimulation for Chronic Lower Limb Pain
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
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:
None
Brief Summary:
By combining the usual care of patients eligible for spinal cord stimulation SME with measurements of the HRV index Heart Rate Variability objective measurements of activity number of steps quality of sleep and measurements of connectivity obtained by anatomical and functional magnetic resonance imaging fMRI the collection of preliminary data necessary for the analysis of markers correlated with the efficiency of stimulation will be possible Ultimately these markers could be used to optimize the perioperative management of these patients
Detailed Description:
The rebellious chronic neuropathic pain of the lower limbs including the sequelae lumbosciatica causes a major functional repercussion and an impairment of the quality of life Spinal cord stimulation SCS is offered when other treatments are ineffective or insufficient K Kumar et al 2007 This technique has been used in routine care for over 20 years with a well-established clinical benefit for these indications and recognized by HAS see 2014 recommendations in appendix 1 Moreover recent technical progress has made it possible to provide better user comfort for implanted patients in particular with new stimulation methods that best adapt to the activities and feelings of the patients De Ridder Vanneste 2016 V Kumar et al 2018
The therapeutic objectives defined between the candidate patient for EMS and the Pain team are part of a personalized rehabilitation and reintegration process This is to reduce the pain felt by the patient but also the functional impact by gradually resuming activity taking into account the specific situation of each patient Functional limitation depends on several factors such as exercise deconditioning but also fear of movement that is essential to assess in patients who are candidates for EMS Patient care involves an assessment made by a trained multi-professional team in which the role of the pain coordinator IDEC is central with therapeutic education work through regular physical and telephone consultations Self-administered questionnaires analyzing functional abilities quality of life and pain are currently being used for the pre- and post-operative assessment of patients undergoing EMS Although they are a diagnostic and decision-making tool they nevertheless correspond to a subjective assessment of the patient of his abilities as he sees them and not to an assessment of his actual objective abilities Thus despite the technical progress represented by the new stimulation methods the perioperative assessment of patients treated for EMS lacks personalized tools
The recent development of technological tools that are easy to use on a daily basis such as activity trackers and smartwatches is an attractive option in chronic pathologies but still insufficiently used in current medical practice A review of the literature has shown the value of the use of activity trackers particularly in postoperative follow-up and functional rehabilitation Appelboom et al 2016 and in low back pain patients GORDON BLOXHAM 2017 Another study evaluating the data collected by an actimeter integrated into a stimulation generator compared to the patients verbal report on his activities reports an overestimation of the functional impact by patients in self-evaluation Goudman et al 2018 Likewise a study on the evaluation of the quality of sleep highlighted a difference between the feelings reported by the patient the self-questionnaires and the data recorded in polysomnography Jaeger et al 2019 with a trend to increase sleep disorders All of these studies confirm the limits in terms of the reliability of declarative data and the need for objective measures to assess the symptoms of patients in chronic conditions
In addition some of these devices have recently made it possible to evaluate the vmHRV vagally-mediated Heart Rate Variability index Hernando et al 2018 This physiological index has been studied for MOTIVE_Protocole_v1_20200610 HBD_2020_23 IDRCB 2020-A01731-38 1140 several years and has shown its interest in various chronic pathologies such as depression cardiovascular pathologies fibromyalgia Kemp et al 2010 Thus compared to healthy control subjects patients with chronic pain have a decreased vmHRV index linked to lower vagal activity Koenig et al 2016 In addition in chronic pain patients a correlation was observed between taking analgesics the impact of pain on daily life and a significantly reduced vmHRV index Moreover patients with little relief from drug treatment had the lowest vmHRV index Koenig et al 2015 thus showing a link between this index and the severity of chronic pain its daily impact l effectiveness of drug treatment Likewise a correlation has been demonstrated between the degree of catastrophization of pain in patients and the vmHRV index Koenig et al 2016 Finally a recent review of the imaging data associated with the measurement of the HRV index suggests a link between functional connectivity and the activity of certain brain regions ventral striatum anterior cingulate cortex medial pre-frontal cortex putamen the ability to manage stress and emotions and the HRV index Thayer et al 2012 thus proposing a neurovisceral integration model The vmHRV index can therefore be considered as an objective marker in the assessment of emotional and physiological coping skills in a patient with chronic pain This aspect is crucial in the evaluation and management of these patients and more particularly when an invasive therapy is envisaged such as EMS
Finally the development of certain imaging sequences makes it possible to study the anatomical diffusion tensor sequences DTI and functional functional MRI sequences connectivity in regions of interest in patients in particular at rest Fox Raichle 2007 During nociceptive stimulation the functional activation of certain regions of interest was demonstrated grouped together under the term pain matrix insula primary and secondary somatosensory cortex thalamus anterior cingulate cortex pre- frontal tonsil and peri-acqueductal gray matter Apkarian et al 2005 Leknes Tracey 2008 Chronic pain alters the functioning of neural circuits in these regions leading to changes in connectivity and activity observable in neuroimaging Baliki et al 2012 Wood et al 2007 A prospective study conducted in 39 patients has also shown the predictive character of some of these changes during the chronicization of pain in a cohort of patients suffering from subacute low back pain Baliki et al 2012 patients developing pain patients which lasts beyond 6 months immediately presented an alteration in the functioning of the neural circuits involved in motivation with a stronger anatomical and functional connectivity between the nucleus accumbens and the medial pre-frontal cortex compared to the patients recovering from the subacute episode Since then other studies have suggested a link between the process of pain chronicization and changes in the anatomical and functional connectivity of cortico-striated circuits involved in cognitive and motivational aspects Navratilova Porreca 2014 Activation of the meso-limbic motivational and reward circuit has also been shown to be involved in the perception of pain relief Leknes et al 2011 Navratilova et al 2012 Seymour et al 2005
The interest of these new cardiac markers HRV radiological anatomical and functional connectivity in MRI and activity connected watch in the management of patients eligible for stimulation medullary will be evaluate The use of a connected watch continuously measuring activity number of steps distance covered sleep duration of deep and light sleep number of nocturnal awakenings and the HRV index could provide an objective assessment and complementary to the self-questionnaires and the usual interviews The MRI profile of anatomical and functional connectivity in the regions of interest linked to chronic pain and motivation in patients treated for EMS would allow to seek a link between functional outcome motivation and the ability to adapt and manage stress
By combining the usual care of patients eligible for an EMS with measurements of the HRV index objective measurements of activity number of steps quality of sleep and connectivity measurements obtained on MRI the collection of preliminary data to identify markers correlated with the effectiveness of EMS will be possible Ultimately these markers could be used to optimize the perioperative management of these patients
The therapeutic objectives defined between the candidate patient for EMS and the Pain team are part of a personalized rehabilitation and reintegration process This is to reduce the pain felt by the patient but also the functional impact by gradually resuming activity taking into account the specific situation of each patient Functional limitation depends on several factors such as exercise deconditioning but also fear of movement that is essential to assess in patients who are candidates for EMS Patient care involves an assessment made by a trained multi-professional team in which the role of the pain coordinator IDEC is central with therapeutic education work through regular physical and telephone consultations Self-administered questionnaires analyzing functional abilities quality of life and pain are currently being used for the pre- and post-operative assessment of patients undergoing EMS Although they are a diagnostic and decision-making tool they nevertheless correspond to a subjective assessment of the patient of his abilities as he sees them and not to an assessment of his actual objective abilities Thus despite the technical progress represented by the new stimulation methods the perioperative assessment of patients treated for EMS lacks personalized tools
The recent development of technological tools that are easy to use on a daily basis such as activity trackers and smartwatches is an attractive option in chronic pathologies but still insufficiently used in current medical practice A review of the literature has shown the value of the use of activity trackers particularly in postoperative follow-up and functional rehabilitation Appelboom et al 2016 and in low back pain patients GORDON BLOXHAM 2017 Another study evaluating the data collected by an actimeter integrated into a stimulation generator compared to the patients verbal report on his activities reports an overestimation of the functional impact by patients in self-evaluation Goudman et al 2018 Likewise a study on the evaluation of the quality of sleep highlighted a difference between the feelings reported by the patient the self-questionnaires and the data recorded in polysomnography Jaeger et al 2019 with a trend to increase sleep disorders All of these studies confirm the limits in terms of the reliability of declarative data and the need for objective measures to assess the symptoms of patients in chronic conditions
In addition some of these devices have recently made it possible to evaluate the vmHRV vagally-mediated Heart Rate Variability index Hernando et al 2018 This physiological index has been studied for MOTIVE_Protocole_v1_20200610 HBD_2020_23 IDRCB 2020-A01731-38 1140 several years and has shown its interest in various chronic pathologies such as depression cardiovascular pathologies fibromyalgia Kemp et al 2010 Thus compared to healthy control subjects patients with chronic pain have a decreased vmHRV index linked to lower vagal activity Koenig et al 2016 In addition in chronic pain patients a correlation was observed between taking analgesics the impact of pain on daily life and a significantly reduced vmHRV index Moreover patients with little relief from drug treatment had the lowest vmHRV index Koenig et al 2015 thus showing a link between this index and the severity of chronic pain its daily impact l effectiveness of drug treatment Likewise a correlation has been demonstrated between the degree of catastrophization of pain in patients and the vmHRV index Koenig et al 2016 Finally a recent review of the imaging data associated with the measurement of the HRV index suggests a link between functional connectivity and the activity of certain brain regions ventral striatum anterior cingulate cortex medial pre-frontal cortex putamen the ability to manage stress and emotions and the HRV index Thayer et al 2012 thus proposing a neurovisceral integration model The vmHRV index can therefore be considered as an objective marker in the assessment of emotional and physiological coping skills in a patient with chronic pain This aspect is crucial in the evaluation and management of these patients and more particularly when an invasive therapy is envisaged such as EMS
Finally the development of certain imaging sequences makes it possible to study the anatomical diffusion tensor sequences DTI and functional functional MRI sequences connectivity in regions of interest in patients in particular at rest Fox Raichle 2007 During nociceptive stimulation the functional activation of certain regions of interest was demonstrated grouped together under the term pain matrix insula primary and secondary somatosensory cortex thalamus anterior cingulate cortex pre- frontal tonsil and peri-acqueductal gray matter Apkarian et al 2005 Leknes Tracey 2008 Chronic pain alters the functioning of neural circuits in these regions leading to changes in connectivity and activity observable in neuroimaging Baliki et al 2012 Wood et al 2007 A prospective study conducted in 39 patients has also shown the predictive character of some of these changes during the chronicization of pain in a cohort of patients suffering from subacute low back pain Baliki et al 2012 patients developing pain patients which lasts beyond 6 months immediately presented an alteration in the functioning of the neural circuits involved in motivation with a stronger anatomical and functional connectivity between the nucleus accumbens and the medial pre-frontal cortex compared to the patients recovering from the subacute episode Since then other studies have suggested a link between the process of pain chronicization and changes in the anatomical and functional connectivity of cortico-striated circuits involved in cognitive and motivational aspects Navratilova Porreca 2014 Activation of the meso-limbic motivational and reward circuit has also been shown to be involved in the perception of pain relief Leknes et al 2011 Navratilova et al 2012 Seymour et al 2005
The interest of these new cardiac markers HRV radiological anatomical and functional connectivity in MRI and activity connected watch in the management of patients eligible for stimulation medullary will be evaluate The use of a connected watch continuously measuring activity number of steps distance covered sleep duration of deep and light sleep number of nocturnal awakenings and the HRV index could provide an objective assessment and complementary to the self-questionnaires and the usual interviews The MRI profile of anatomical and functional connectivity in the regions of interest linked to chronic pain and motivation in patients treated for EMS would allow to seek a link between functional outcome motivation and the ability to adapt and manage stress
By combining the usual care of patients eligible for an EMS with measurements of the HRV index objective measurements of activity number of steps quality of sleep and connectivity measurements obtained on MRI the collection of preliminary data to identify markers correlated with the effectiveness of EMS will be possible Ultimately these markers could be used to optimize the perioperative management of these patients
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