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

Primary Purpose

STROKE

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
- Postoperative Antagonistic Peripheral Magnetic Stimulation
Selective Peripheral Magnetic Stimulation
Kinesics
Sponsored by
Juan Carlos M. Andreani MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STROKE focused on measuring Barthel Scale, Disability, Modified Ashworth Scale, Right Arm, Neuromodulation, Spasticity, Stroke

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Sham Comparator

    Active Comparator

    Arm Label

    Kinesics

    surgery

    Magnetic Stimulation

    Arm Description

    - Classic Rehabilitation and Kinesic Therapy

    - 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.

    - 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

    Outcomes

    Primary Outcome Measures

    Modified Ashworth Scale (MAS)
    - 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

    Fugl - Meyer Scale
    Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb
    Barthel Scale
    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

    Full Information

    First Posted
    August 16, 2014
    Last Updated
    June 17, 2023
    Sponsor
    Juan Carlos M. Andreani MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02226432
    Brief Title
    Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity
    Acronym
    Andreani2
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2024 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Juan Carlos M. Andreani MD

    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 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    STROKE
    Keywords
    Barthel Scale, Disability, Modified Ashworth Scale, Right Arm, Neuromodulation, Spasticity, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesics
    Arm Type
    Sham Comparator
    Arm Description
    - Classic Rehabilitation and Kinesic Therapy
    Arm Title
    surgery
    Arm Type
    Sham Comparator
    Arm Description
    - 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.
    Arm Title
    Magnetic Stimulation
    Arm Type
    Active Comparator
    Arm Description
    - 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
    Intervention Type
    Procedure
    Intervention Name(s)
    - Postoperative Antagonistic Peripheral Magnetic Stimulation
    Other Intervention Name(s)
    - Preoperative Peripheral Nerve Blockade, - Selective Peripheral Neurotomy, - Kinesic Rehabilitation Therapy
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Selective Peripheral Magnetic Stimulation
    Intervention Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Kinesics
    Other Intervention Name(s)
    Classic Rehabilitation Treatment
    Intervention Description
    Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
    Primary Outcome Measure Information:
    Title
    Modified Ashworth Scale (MAS)
    Description
    - Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.
    Time Frame
    Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.
    Secondary Outcome Measure Information:
    Title
    Fugl - Meyer Scale
    Description
    Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb
    Time Frame
    Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
    Title
    Barthel Scale
    Description
    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
    Time Frame
    Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juan Carlos Mario Andreani, MD
    Phone
    91150531392
    Email
    jcmandreani@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Carlos Mario Andreani, MD
    Organizational Affiliation
    Fundación CENIT
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Fabián César Piedimonte, MD
    Organizational Affiliation
    Fundación CENIT - President
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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