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

NCT02226432 | Not Yet Recruiting

• 1 other identifier: Andreani, JCM 2
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

STROKE

Keywords

Barthel Scale; Disability; Modified Ashworth Scale; Right Arm; Neuromodulation; Spasticity; Stroke

Outcome Measures

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.

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

Secondary Outcomes (2)

• Fugl - Meyer Scale

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

• Barthel Scale

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

Study Arms (3)

Kinesics

SHAM COMPARATOR

\- Classic Rehabilitation and Kinesic Therapy

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

surgery

SHAM COMPARATOR

\- 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

Magnetic Stimulation

ACTIVE COMPARATOR

\- 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

- Postoperative Antagonistic Peripheral Magnetic Stimulation 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

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

Kinesics; Magnetic Stimulation; surgery

Selective Peripheral Magnetic Stimulation 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)

Magnetic Stimulation

Kinesics OTHER

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

Kinesics; Magnetic Stimulation; surgery

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe and refractory right Hemiparesia or Hemiplegia, affecting hand function.
• Failure of kinesic treatment
• points or more Improvement on Modified Ashworth Scale after anestethic blockade

You may not qualify if:

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

Sponsors & Collaborators

• Juan Carlos M. Andreani MD: lead

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Carlos Mario Andreani, MD

  Fundación CENIT

  STUDY DIRECTOR

• Fabián César Piedimonte, MD

  Fundación CENIT - President

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Carlos Mario Andreani, MD

CONTACT

91150531392; jcmandreani@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 27, 2014
• Study Start: March 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share