Clinical trial NCT02226432: Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: STROKE
Keywords: Barthel Scale
Disability
Modified Ashworth Scale
Right Arm
Neuromodulation
Spasticity
Stroke
Lead sponsor: Sociedad Argenttina de Neuromodulación
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.
Secondary outcomes:
measure: Fugl - Meyer Scale
timeFrame: Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
measure: Barthel Scale
timeFrame: Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.
Other outcomes:
Locations:
Study officials:
affiliation: Fundación CENIT
name: Juan Carlos Mario Andreani, MD
role: STUDY_DIRECTOR
affiliation: Fundación CENIT - President
name: Fabián César Piedimonte, MD
role: PRINCIPAL_INVESTIGATOR
References: