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Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity (Andreani2)

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ClinicalTrials.gov Identifier: NCT02226432
Recruitment Status : Not yet recruiting
First Posted : August 27, 2014
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
STROKE Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation Device: Selective Peripheral Magnetic Stimulation Other: Kinesics Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Sham Comparator: Kinesics
- Classic Rehabilitation and Kinesic Therapy
Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation

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

Other: Kinesics
Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
Other Name: Classic Rehabilitation Treatment

Sham Comparator: surgery

- Surgery:

Selective Peripheral Neurotomy is surgical a method of section on suplying peripheral nerves of motor fascicles to relieve harmful spasticity. An intraoperative stimulation of motor fascicles is done, and those which abnormal spreading on far placed myotomes are more evident are chosen to be sectioned.

Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation

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

Other: Kinesics
Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
Other Name: Classic Rehabilitation Treatment

Active Comparator: Magnetic Stimulation
- Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity, infrathreshold 80 per cent of minimal intensity able to produce always muscle contraccion. Trials repeated twice a week in sessions of 30 minutes during 6 months
Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation

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

Device: Selective Peripheral Magnetic Stimulation
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)

Other: Kinesics
Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
Other Name: Classic Rehabilitation Treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226432


Contacts
Contact: Juan Carlos Mario Andreani, MD 91150531392 jcmandreani@gmail.com

Sponsors and Collaborators
Juan Carlos M. Andreani MD
Investigators
Study Director: Juan Carlos Mario Andreani, MD Fundación CENIT
Principal Investigator: Fabián César Piedimonte, MD Fundación CENIT - President

Responsible Party: Juan Carlos M. Andreani MD, MD, Sociedad Argenttina de Neuromodulación
ClinicalTrials.gov Identifier: NCT02226432     History of Changes
Other Study ID Numbers: Andreani, JCM 2
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación:
Barthel Scale
Disability
Modified Ashworth Scale
Right Arm
Neuromodulation
Spasticity
Stroke

Additional relevant MeSH terms:
Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms