Ultrasound-Guided Percutaneous Neuromodulation in Spasticity (NEUROECO)

The Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterised by the appearance of lesions, characterised by heterogeneity in their anatomopathological, clinical and radiological presentation.

Its aetiology is complex and multifactorial, with genetic and environmental interactions with a predominance in women (3:1) and is the second leading cause of disability in young adults (25-30 years). It has a socio-economic impact, affecting interpersonal relationships and causing a significant reduction in quality of life.

MAIN OBJECTIVE To assess the effect on spasticity of the Percutaneous Ultrasound-guided Neuromodulation (PMN) technique in patients diagnosed with MS with upper limb spasticity.

SECONDARY OBJECTIVES

• To assess changes in the strength parameter of the wrist flexor musculature wrist before and after the application of a PMN programme.
• To assess changes in the functionality scales (modified Asworth, established for spasticity
• To assess changes in the range of motion (ROM) of the joints under study.
• Assess changes in the quality of life scale (MSQOL54).
• To assess the adverse effects of the technique.

All patients will receive a Percutaneous Echoguided Neuromodulation (PNM) in the median nerve at the elbow, medial to the brachial artery, running between the humeral and ulnar heads of the pronator teres muscle. Once the nerve is located, a needle shall be inserted in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle cont raction for 1.5 minutes.

After assessing the correct application of ethics in the study, it was decided to use the individual's own baseline data as a control group, as simulating the technique is complex.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Procedure: Percutaneous Echoguided Neuromodulation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Javier Ormazábal; Phone Number: 922678968
• Study Contact Backup: Name: Montserrat González Plata, MD; Phone Number: 922678968; Email: montserrat.gonzalezplatas@gmail.com

Study Locations

• Spain
  • S/C De Tenerife
    • La Laguna, S/C De Tenerife, Spain, 38320
      • UICEC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sign the consent form to participate in the study
• Be a patient diagnosed with Multiple Sclerosis.
• Be over 18 years of age and less than or equal to 55 years of age.
• Have spasticity (Asworth 2) in the upper limb.
• Be able to travel to the place of the session

Exclusion Criteria:

• Failure to comply with the above
• Withdrawal of informed consent
• Having a disease associated with MS that is incompatible with the technique. Use of anticoagulation
• Cognitive impairment
• Belenophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neuromodulation; This study has only 1 arm and the control group is their baseline data	Procedure: Percutaneous Echoguided Neuromodulation; Once the nerve is located, a needle is introduced in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle contraction for 1.5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity	Modified Ashworth Scale which is a measure for the quantification of hypertonia of any articulation. It is a qualitative exam, with values in a range 0 to 4.	8 weeks
Patient's quality of life	MSQOL 54: It's a questionnaire that measure mental and physical aspects. The range is from 0 to 100, where 100 is the highest grade of quality of life	8 weeks
Patient Functionality	Barthel Index: It's a measure of physical disability which assess functional disability in the activities of the daily life (ADL). The global range can vary between 0 (completely dependent) and 100 points (completely independent)	8 weeks
9 hole peg test	9HP: Test to assess limb function upper / hand. The patient is asked to incorporate 9 pins into a board with 9 holes, one in each hole, as fast as they can using their dominant hand. Once the test is done, it is repeated one more time for each hand.	8 weeks
Muscle strength	Dynamometer: Dynamometry is an objective way of measuring muscle strength performed by an individual, managing to express it as a quantitative variable, which facilitates its assessment.	8 weeks
Range of Motion	Goniometer: Is used to assess changes in the range of motion (ROM) of the joints. The measurements made can be influenced by different factors: the ability to locate appropriate anatomical landmarks, evaluator experience, sex, weight, and age of the subject, as well as the type of joint. the level of reliability in the scan is somewhat greater in the joints of the upper limb than in the lower limb and this rises when more measurements are taken by the same examiner and on the same day.	8 weeks
Satisfaction Scale	EVA Scale: It is an instrument for measuring subjective characteristics or attitudes that cannot be measured directly. Range:1-10	Immediately after the treatment

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 2, 2021
• Primary Completion (ANTICIPATED): January 31, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (ACTUAL): September 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: NEUROECO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No