Clinical trial NCT05544175: NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy
Official title: NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy on a Neurophysiological Basis Improves Not Only Pain But Also Mobility in Spastic Paraparesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord
Keywords: spinal cord stimulation
physiotherapy
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this project, the aim is to verify that neuromodulation therapy (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs.

Detailed description: So far, posterior spinal cord neurostimulation (NM SCS) has been applied as a standard in patients with the most severe forms of pharmacoresistant neuropathic pain. The most recent research of the last 1-2 years brings clinical findings that, in a mode and modified arrangement, it could even induce rhythmic muscle activity of the lower limbs and help in verticalization and assisted bipedal locomotion.

In this project, the aim is to verify that neuromodulation therapy SCS (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs.

In the therapy, the neuronal circuits of the lumbosacral region, where the so-called central pattern generators for locomotion are located will be targeted. Neurostimulation of this area will generate motor movement patterns corresponding to the previous mapping of the corresponding muscle groups. These will be supported by intensive physiotherapy on a neurophysiological basis - thanks to it and the facilitation of movement by neurostimulation, global motor patterns will be triggered, and motor programs stored at the subcortical level will be activated. Their memorization and subsequent spontaneous retrieval will facilitate sensorimotor learning techniques.

Current research further shows that neurostimulation stimulates neurons in Rexed laminae 3-5, specifically a group of neurons designated as SC VSX2 and subsequently proprioceptive fibres. Physiotherapy will enhance the effect of neuromodulation by stimulating proprioceptors using soft and neurophysiologically based techniques. Proprioceptive fibres make connections to motoneurons and also ascend through the spinal cord to the brain, and thus reflex motor movements can be triggered. Information about them is carried to the brain by ascending pathways, and thus a free awareness of the movement facilitated by the neurostimulator occurs. All these mechanisms should potentiate plasticity (and lead to the restoration of locomotion.

Eligibility criteria: Inclusion Criteria:

spinal cord lesion

Exclusion Criteria:

other neurological conditions

Primary outcomes:
measure: Change in Muscle strength at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in Spasticity at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
measure: Change from Baseline Timed Up And Go at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
measure: Change from Baseline Berg Balance Scale at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
measure: Change from Baseline The 10 Metre Walk Test at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
measure: Change from Baseline The 6 Minute Walk Test at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
measure: Change in Walking Index for Spinal Cord Injury at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
Secondary outcomes:
measure: Change in Visual Analogue Scale for pain at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in The Fatigue Scale for Motor and Cognitive Functions at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in SYMBOL DIGIT MODALITIES TEST at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in European Health Questionnaire at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in the 36-Item Short Form Survey Instrument at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change from Baseline Goal Attainment scale at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in the Spinal Cord Independence Measure at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
Other outcomes:
measure: Change from Baseline the serum level of Long non-coding ribonucleic acid (lncRNA) at 2 weeks, 6 weeks, 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in pattern of brain activity at 6 and 12 months
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Follow up (6 and 12 month after beginning of the study).
measure: Change in muscle activity
timeFrame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Follow up (6 and 12 month after beginning of the study).
Locations:
city: Prague
country: Czechia
facility: Departmet of revmatology and rehabilitation, Faculty Thomayer Hospital
Study officials:
affiliation: Department of rehabilitation, Third Faculty of Medicine, Charles University
name: Kamila Řasová, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References: