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

STROKE Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02226432
• Other study ID #: Andreani, JCM 2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: March 2026

Study information

• Verified date: June 2023
• Source: Sociedad Argenttina de Neuromodulación
• Contact: Juan Carlos Mario Andreani, MD
• Phone: 91150531392
• Email: jcmandreani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

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

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)

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juan Carlos M. Andreani MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.
Secondary	Fugl - Meyer Scale	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.
Secondary	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	Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.