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

NCT ID: NCT02226432

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-03-31

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.

Conditions

STROKE

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Kinesics

\- Classic Rehabilitation and Kinesic Therapy

Group Type: SHAM_COMPARATOR

- Postoperative Antagonistic Peripheral Magnetic Stimulation

Intervention Type: 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

Kinesics

Intervention Type: OTHER

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

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.

Group Type: SHAM_COMPARATOR

- Postoperative Antagonistic Peripheral Magnetic Stimulation

Intervention Type: 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

Kinesics

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

- Postoperative Antagonistic Peripheral Magnetic Stimulation

Intervention Type: 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

Selective Peripheral Magnetic Stimulation

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

- 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

Intervention Type: PROCEDURE

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)

Intervention Type: DEVICE

Kinesics

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

Intervention Type: OTHER

Other Intervention Names

- Preoperative Peripheral Nerve Blockade; - Selective Peripheral Neurotomy; - Kinesic Rehabilitation Therapy; Classic Rehabilitation Treatment

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan Carlos M. Andreani MD

OTHER

Sponsor Role: lead

Responsible Party

Juan Carlos M. Andreani MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan Carlos Mario Andreani, MD

Role: STUDY_DIRECTOR

Fundación CENIT

Fabián César Piedimonte, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación CENIT - President

Central Contacts

Juan Carlos Mario Andreani, MD

Role: CONTACT

jcmandreani@gmail.com

91150531392

Other Identifiers

Andreani, JCM 2

Identifier Type: -

Identifier Source: org_study_id