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

Juan Carlos M. Andreani MD

Status: Not yet enrolling

Conditions: STROKE

Treatments: Device: Selective Peripheral Magnetic Stimulation; Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation; Other: Kinesics

Study type: Interventional

Funder types: Other

Identifiers

NCT02226432

Andreani, JCM 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups

Kinesics

Sham Comparator group

Description:

- Classic Rehabilitation and Kinesic Therapy

Treatment:

Other: Kinesics

Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation

surgery

Sham Comparator group

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.

Treatment:

Other: Kinesics

Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation

Magnetic Stimulation

Active Comparator group

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

Treatment:

Other: Kinesics

Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation

Device: Selective Peripheral Magnetic Stimulation