CClinicalTrials.gg
Not yet recruitingNCT02226432Andreani2Updated Aug 19, 2024

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

An interventional study of - Postoperative Antagonistic Peripheral Magnetic Stimulation and Selective Peripheral Magnetic Stimulation in STROKE, sponsored by Juan Carlos M. Andreani MD. Not yet recruiting. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Juan Carlos M. Andreani MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
25 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • STROKE

Keywords

  • Barthel Scale
  • Disability
  • Modified Ashworth Scale
  • Right Arm
  • Neuromodulation
  • Spasticity
  • Stroke
03

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Severe cardiovascular disease
  • Severe pulmonary disease
  • Neoplasia advanced disease
  • Joint anchylosis
  • Irreversible retraction for muscle fibrosis
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • Sham comparator
    Kinesics

    - Classic Rehabilitation and Kinesic Therapy

    Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation · Other: Kinesics

  • 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 · Other: Kinesics

  • 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 · Device: Selective Peripheral Magnetic Stimulation · Other: Kinesics

Interventions

  • 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

    Also known as: - Preoperative Peripheral Nerve Blockade, - Selective Peripheral Neurotomy, - Kinesic Rehabilitation Therapy

  • DeviceSelective 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)

  • OtherKinesics

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

    Also known as: Classic Rehabilitation Treatment

05

What researchers measure

Primary outcomes

  1. 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.

    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 outcomes

  1. Fugl - Meyer Scale

    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.

  2. 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

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02226432
Lead sponsor
Juan Carlos M. Andreani MD
Responsible party
Juan Carlos M. Andreani MD (MD, Sociedad Argenttina de Neuromodulación) — Sponsor-investigator
First posted
Aug 27, 2014
Start date
Mar 2025 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Aug 19, 2024

Study contacts

Juan Carlos Mario Andreani, MD
Contact
jcmandreani@gmail.com
91150531392
Juan Carlos Mario Andreani, MD
study director · Fundación CENIT
Fabián César Piedimonte, MD
principal investigator · Fundación CENIT - President

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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