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Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05053984
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospital Universitario de Canarias
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Neuromodulation

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

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

Status

Address

UICEC

La Laguna, S/C De Tenerife, 38320

Site Contact

922678968

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