Multiple SclerosisNEUROECONCT05053984
Ultrasound-Guided Percutaneous Neuromodulation in Spasticity
A study testing Percutaneous Echoguided Neuromodulation in people with Multiple Sclerosis, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Percutaneous Echoguided Neuromodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Alberto Javier Ormazábal contact
About this study
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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Percutaneous Echoguided Neuromodulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Echoguided NeuromodulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation | Experimental | This study has only 1 arm and the control group is their baseline data Receives: Procedure: Percutaneous Echoguided Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Satisfaction Scale
EVA Scale: It is an instrument for measuring subjective characteristics or attitudes that cannot be measured directly. Range:1-10
Measured: Immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start2 Nov 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053984
- Sponsor's protocol ID
- NEUROECO
- Acronym
- NEUROECO
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Percutaneous Neuromodulation in Spasticity
- ClinicalTrials.gov ID
- NCT05053984
- Acronym / sponsor ID
- NEUROECO / NEUROECO
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 2 Nov 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation | Experimental | Procedure: Percutaneous Echoguided NeuromodulationThis study has only 1 arm and the control group is their baseline data |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Echoguided NeuromodulationOnce 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. | Procedure or surgery | Neuromodulation |
Primary outcome
Spasticity
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: Immediately after the treatment
EVA Scale: It is an instrument for measuring subjective characteristics or attitudes that cannot be measured directly. Range:1-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Javier Ormazábal contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Echoguided Neuromodulation in people with Multiple Sclerosis, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Javier Ormazábal (922678968), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.