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NCT Number: NCT05544175

NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy

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.

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Key information

Conditions

Spinal Cord

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departmet of revmatology and rehabilitation, Faculty Thomayer Hospital

Prague, Czechia

Location contact

Tom Philipp, Ph.D.

CONTACT

[email protected]

+420737273589

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

spinal cord lesion

Exclusion criteria

other neurological conditions

Treatment and study plan

NEUROMOdulation pain therapy in combination with intensive physiotherapy

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.

Primary outcomes

  1. Change in Muscle strength at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    Hip flexion, abduction and extension, knee flexion and extension, plantar flexion and dorsiflexion using a microFET2 digital dynamometer. The higher value, the better function (higher strength).

  2. Change in Spasticity at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)

    Hip flexors, knee flexors and extensors, dorsal and plantar flexors using the Modified Ashworth scale. The higher value, the worse function (higher spasticity).

  3. Change from Baseline Timed Up And Go at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)

    The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility.

  4. Change from Baseline Berg Balance Scale at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)

    The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility.

  5. Change from Baseline The 10 Metre Walk Test at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)

    A performance measure used to assess walking speed in meters per second over 10 meters. Shorter times reflect better mobility.

  6. Change from Baseline The 6 Minute Walk Test at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)

    A long walking capacity test recording the maximal distance a subject walks at the fastest speed possible in 6 minutes. The more distance covered, the better the walking performance is.

  7. Change in Walking Index for Spinal Cord Injury at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    questionnaire from 0 to 20. Higher number means better function.

Secondary outcomes

  1. Change in Visual Analogue Scale for pain at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    scale from 0 to 10. Higher number means worse function (higher subjective feeling of pain)

  2. Change in The Fatigue Scale for Motor and Cognitive Functions at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    Questionnaire with 20 questions on fatigue. Higher number, worse fatigue.

  3. Change in SYMBOL DIGIT MODALITIES TEST at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    Cognitive testing (putting right symbols in 90 seconds). Higher number, better function.

  4. Change in European Health Questionnaire at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    questionnaire on Quality of Life. Higher value, better quality of life.

  5. Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    the 36-item questionnaire, higher score means higher disability

  6. Change in the 36-Item Short Form Survey Instrument at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    36 item questionnaire. Higher number, worse quality of life.

  7. Change from Baseline Goal Attainment scale at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome.

  8. Change in the Spinal Cord Independence Measure at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    17 item questionnaire. Higher number, better function (lower independence).

Other outcomes

  1. Change from Baseline the serum level of Long non-coding ribonucleic acid (lncRNA) at 2 weeks, 6 weeks, 6 and 12 months

    Time frame: 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).

    LncRNAs are defined as RNA transcripts >200 nucleotides with limited coding potential, but multiple function of binding different DNA, mRNAs and proteins, and they can be expressed under different conditions. As an improvement will be interpreted a significant mean fold change in gene expression (≥ 2.0, p value ≤ 0.05) between two groups following endogenous gene standardisation and normalization through control adjustment to a value of 1.0.

  2. Change in pattern of brain activity at 6 and 12 months

    Time frame: 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).

    fMRI will follow the changes in functional and structural brain connectivity. All fMRI examinations shall be performed in MR system Siemens Vida 3T located in IKEM using 64-channel RF head coil. Examination protocol will include not only essential structural imaging (3D SPACE FLAIR sequence with isotropic spatial resolution of 1 mm3), but also the measurement of functional connectivity using resting state fMRI and measurement of structural connectivity by means of the evaluation of spatial distribution of molecular diffusion (generalized DTI - diffusion tensor imaging, with 108 spatial directions and 3 b-factors allowing the reconstruction not only of fractional anisotropy but also the diffusion kurtosis imaging). The duration of the entire MR examination should not exceed 45 minutes. Extent activation, better value.

  3. Change in muscle activity

    Time frame: 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).

    Needle electromyography. Higher value, higher function.

Study contacts

Contact information is provided by the study sponsor or research team.

Kamila Řasová, assoc. prof.

CONTACT

[email protected]

+420604511416

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy on a Neurophysiological Basis Improves Not Only Pain But Also Mobility in Spastic Paraparesis

Acronym: NEUROMOFY

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 16, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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