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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02226432
Acronym
Andreani2
Enrollment
15
Registered
2014-08-27
Start date
2025-03-31
Completion date
2027-03-31
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STROKE

Keywords

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

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.

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

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.

Sponsors

Juan Carlos M. Andreani MD
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Ashworth Scale (MAS)Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.\- Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.

Secondary

MeasureTime frameDescription
Fugl - Meyer ScalePost operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb
Barthel ScalePost operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.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

Contacts

Primary ContactJuan Carlos Mario Andreani, MD
jcmandreani@gmail.com91150531392

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026