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

June 17, 2023 updated by: Juan Carlos M. Andreani MD

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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
Other: Kinesics
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
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
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
Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Carlos M. Andreani MD

Investigators

  • Study Director: Juan Carlos Mario Andreani, MD, Fundación CENIT
  • Principal Investigator: Fabián César Piedimonte, MD, Fundación CENIT - President

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 16, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimated)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Andreani, JCM 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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