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NCT Number: NCT02226432

Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity

The objective of the present trial is to demonstrate Magnetic stimulation as an useful complementary treatment in order to improve patients' evolution without the need of extensive surgical lesion.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients with refractory post stroke upper right limb spasticity will operated by Median nerve or Median/ Cubital selective neurotomy depending upon more affected territories.

Some of them could be also also operated with posterioris tibialis neurotomy to treat equine's foot whenever also clinically present. Preoperative motor blocks might be possitive in all cases.

A week later, they will be treated by magnetic stimulation on selected antagonistic muscles, related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with an equipment Dipol Zeta D5 (Russian Federation), with 1.5 tesla of intensity.

Trials will be repeated twice a week in sessions of 30 minutes during 6 months with simultaneous intensive classic rehabilitation.

Patients will be monthly evaluated by the mean score of Modified Ashworth Scale, related to fingers, wrist, elbow and shoulder and also with Barthel Scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe and refractory right Hemiparesia or Hemiplegia, affecting hand function.
  • Failure of kinesic treatment
  • 2 points or more Improvement on Modified Ashworth Scale after anestethic blockade

Exclusion criteria

  • Severe cardiovascular disease
  • Severe pulmonary disease
  • Neoplasia advanced disease
  • Joint anchylosis
  • Irreversible retraction for muscle fibrosis

Treatment and study plan

- Postoperative Antagonistic Peripheral Magnetic Stimulation

Procedure

Selected patients will be treated with Selective peripheral Neurotomy followed by an standartized cycle of Selective Peripheral Magnetic Stimulation and classic post operative Kinesic Therapy.

  • Sham patients (n 10) will be treated with classic post operative Kinesic Therapy.
  • Comparision of both groups will be statistified

Other names: - Preoperative Peripheral Nerve Blockade, - Selective Peripheral Neurotomy, - Kinesic Rehabilitation Therapy

Selective Peripheral Magnetic Stimulation

Device

Peripheral 1.5 tesla intensity, 10 Hz of Frequency, with "eight saped" bovine, of 30 minutes, aplied on antagonistic muscles, twice a week. Intensity will be infrathreshold, 80 per cent of the individual threshold (minimal amount of intensity producing always a muscle motor response in each particular patient)

Kinesics

Other

Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.

Other names: Classic Rehabilitation Treatment

Primary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.

    • Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.

Secondary outcomes

  1. Fugl - Meyer Scale

    Time frame: Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.

    Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb

  2. Barthel Scale

    Time frame: Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.

    Pre and post operative evaluation of ten basic current dayly life activities, scored 10, 5 or 0 points each one, a total of 100 points

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Carlos Mario Andreani, MD

CONTACT

[email protected]

91150531392

Sponsors and collaborators

Lead sponsor

Juan Carlos M. Andreani MD

Other

Registry information

Official study title

The Use of Antagonistic Muscle Magnetic Stimulation to Avoid Extensive Lesions and Improve Results of Selective Peripheral Neurotomy on Refractory and I POost Stroke Spasticity With Exclusive or Predominant Right Upper Limb Arm

Acronym: Andreani2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2014
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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