NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy

NCT ID: NCT05544175

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-22

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.

Conditions

Spinal Cord

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NEUROMOdulation pain therapy in combination with intensive physiotherapy

Neuromodulation therapy (low-voltage electrical stimulation of the posterior roots of the spinal cord) by electrodes inserted epidurally from a laminotomy in the lumbosacral region.

Intensive, four hour per day, individual physiotherapy (soft techniques, methods based on neurophysiology, so-called neuroproprioceptive "facilitation, inhibition" (Vojta's reflex method, Motor programs activating therapy, Proprioceptive neuromuscular stimulation, Bobath concept) will be combined with methods of acquiring motor skills (individualized therapy using the knowledge of sensorimotor learning) will take minimally one month.

Group Type: EXPERIMENTAL

NEUROMOdulation pain therapy in combination with intensive physiotherapy

Intervention Type: PROCEDURE

Neuromodulation: Spinal cord stimulation affects nerve tissues with a defined electrical current. We will use low-voltage electrical stimulation of the posterior roots of the spinal cord in the MRI region of the localized conus medullaris. Electrodes are inserted epidurally from a laminotomy in the lumbosacral region.

Physiotherapy will be based on recommendations for spinal patients.

Interventions

NEUROMOdulation pain therapy in combination with intensive physiotherapy

Neuromodulation: Spinal cord stimulation affects nerve tissues with a defined electrical current. We will use low-voltage electrical stimulation of the posterior roots of the spinal cord in the MRI region of the localized conus medullaris. Electrodes are inserted epidurally from a laminotomy in the lumbosacral region.

Physiotherapy will be based on recommendations for spinal patients.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

spinal cord lesion

Exclusion Criteria

other neurological conditions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Kamila Řasová

assoc. prof. PhDr. Kamila Řasová, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamila Řasová, assoc. prof.

Role: PRINCIPAL_INVESTIGATOR

Department of rehabilitation, Third Faculty of Medicine, Charles University

Locations

Departmet of revmatology and rehabilitation, Faculty Thomayer Hospital

Prague, , Czechia

Countries

Czechia

Central Contacts

Kamila Řasová, assoc. prof.

Role: CONTACT

kamila.rasova@lf3.cuni.cz

+420604511416

Facility Contacts

Tom Philipp, Ph.D.

Role: primary

tom.philipp@ftn.cz

+420737273589

Other Identifiers

092022

Identifier Type: -

Identifier Source: org_study_id