NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy

NCT05544175 | Not Yet Recruiting

• 1 other identifier: 092022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord

Keywords

spinal cord stimulation; physiotherapy

Outcome Measures

Primary Outcomes (7)

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

  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).

  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).

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

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

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

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

  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.

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

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

  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.

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

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

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

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

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

  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.

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

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

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

  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 (8)

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

  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).

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

  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).

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

  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).

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

  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).

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

  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 (3)

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

  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).

• Change in pattern of brain activity at 6 and 12 months

  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).

• Change in muscle activity

  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).

Study Arms (1)

NEUROMOdulation pain therapy in combination with intensive physiotherapy

EXPERIMENTAL

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.

Procedure: NEUROMOdulation pain therapy in combination with intensive physiotherapy

Interventions

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.

NEUROMOdulation pain therapy in combination with intensive physiotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• spinal cord lesion

You may not qualify if:

• other neurological conditions

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Departmet of revmatology and rehabilitation, Faculty Thomayer Hospital

Prague, Czechia

Location

Study Officials

• Kamila Řasová, assoc. prof.

  Department of rehabilitation, Third Faculty of Medicine, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamila Řasová, assoc. prof.

CONTACT

+420604511416; kamila.rasova@lf3.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. PhDr. Kamila Řasová, Ph.D.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 22, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD will be made available from 3-months months following the first publication of findings based on the data until 3 years following the first publication.
• Access Criteria: The datasets will be prepared and might be reachable on a request. The study team formally reviews access requests for proposals. The data on an exclusive basis will be made available for third party use/ the new user, which can range from direct provision of data, data analysis collaboration, and/or scientific collaboration.

Locations

CZ (1)