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Ultrasound-Guided Percutaneous Neuromodulation in Spasticity (NEUROECO)

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous Echoguided Neuromodulation
Sponsored by
Hospital Universitario de Canarias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UICEC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuromodulation

Arm Description

This study has only 1 arm and the control group is their baseline data

Outcomes

Primary Outcome Measures

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.
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
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)
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.
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.
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.
Satisfaction Scale
EVA Scale: It is an instrument for measuring subjective characteristics or attitudes that cannot be measured directly. Range:1-10

Secondary Outcome Measures

Full Information

First Posted
August 26, 2021
Last Updated
September 13, 2021
Sponsor
Hospital Universitario de Canarias
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1. Study Identification

Unique Protocol Identification Number
NCT05053984
Brief Title
Ultrasound-Guided Percutaneous Neuromodulation in Spasticity
Acronym
NEUROECO
Official Title
Ultrasound-Guided Percutaneous Neuromodulation in Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario de Canarias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromodulation
Arm Type
Experimental
Arm Description
This study has only 1 arm and the control group is their baseline data
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Echoguided Neuromodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spasticity
Description
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.
Time Frame
8 weeks
Title
Patient's quality of life
Description
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
Time Frame
8 weeks
Title
Patient Functionality
Description
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)
Time Frame
8 weeks
Title
9 hole peg test
Description
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.
Time Frame
8 weeks
Title
Muscle strength
Description
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.
Time Frame
8 weeks
Title
Range of Motion
Description
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.
Time Frame
8 weeks
Title
Satisfaction Scale
Description
EVA Scale: It is an instrument for measuring subjective characteristics or attitudes that cannot be measured directly. Range:1-10
Time Frame
Immediately after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Javier Ormazábal
Phone
922678968
First Name & Middle Initial & Last Name or Official Title & Degree
Montserrat González Plata, MD
Phone
922678968
Email
montserrat.gonzalezplatas@gmail.com
Facility Information:
Facility Name
UICEC
City
La Laguna
State/Province
S/C De Tenerife
ZIP/Postal Code
38320
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

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