STROKEAndreani2NCT02226432
Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity
A study testing - Postoperative Antagonistic Peripheral Magnetic Stimulation, Selective Peripheral Magnetic Stimulation and Kinesics in people with STROKE, run by Juan Carlos M. Andreani MD.
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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- STROKE
- What is being tested?
- - Postoperative Antagonistic Peripheral Magnetic Stimulation, Selective Peripheral Magnetic Stimulation and Kinesics
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cardiovascular disease
- Severe pulmonary disease
- Neoplasia advanced disease
- Joint anchylosis
- Irreversible retraction for muscle fibrosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- STROKE
- Being tested
- - Postoperative Antagonistic Peripheral Magnetic Stimulation, Selective Peripheral Magnetic Stimulation, Kinesics
- Keywords
- Barthel Scale, Disability, Modified Ashworth Scale, Right Arm, Neuromodulation, Spasticity, Stroke
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Postoperative Antagonistic Peripheral Magnetic StimulationProcedure or surgery
Also called - Preoperative Peripheral Nerve Blockade, - Selective Peripheral Neurotomy, - Kinesic Rehabilitation Therapy
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
Selective Peripheral Magnetic StimulationDevice
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)
KinesicsOther
Also called Classic Rehabilitation Treatment
Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
| Study group | Role | What they receive |
|---|---|---|
| Kinesics | Sham comparator | - Classic Rehabilitation and Kinesic Therapy Receives: 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. Receives: 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 Receives: Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation; Device: Selective Peripheral Magnetic Stimulation; Other: Kinesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb
Measured: Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
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
Measured: Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startMar 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STROKEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Carlos M. Andreani MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación
- Investigators
- Juan Carlos Mario Andreani, MD, Study director, Fundación CENITFabián César Piedimonte, MD, Principal investigator, Fundación CENIT - President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226432
- Sponsor's protocol ID
- Andreani, JCM 2
- Acronym
- Andreani2
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2014
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02226432
- Acronym / sponsor ID
- Andreani2 / Andreani, JCM 2
- Conditions
- STROKE
- Keywords
- Barthel Scale, Disability, Modified Ashworth Scale, Right Arm, Neuromodulation, Spasticity, Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Juan Carlos M. Andreani MDUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesics | Sham comparator | Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation, Other: Kinesics- Classic Rehabilitation and Kinesic Therapy |
| surgery | Sham comparator | Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation, Other: Kinesics- 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. |
| Magnetic Stimulation | Active comparator | Procedure: - Postoperative Antagonistic Peripheral Magnetic Stimulation, Device: Selective Peripheral Magnetic Stimulation, Other: Kinesics- 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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Severe cardiovascular disease
- Severe pulmonary disease
- Neoplasia advanced disease
- Joint anchylosis
- Irreversible retraction for muscle fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| - Postoperative Antagonistic Peripheral Magnetic StimulationAlso: - Preoperative Peripheral Nerve Blockade, - Selective Peripheral Neurotomy, - Kinesic Rehabilitation TherapySelected 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 | Procedure or surgery | Kinesics, Magnetic Stimulation, surgery |
| Selective Peripheral Magnetic StimulationPeripheral 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) | Device | Magnetic Stimulation |
| KinesicsAlso: Classic Rehabilitation TreatmentSession of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home. | Other | Kinesics, Magnetic Stimulation, surgery |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: 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.
2 secondary outcomes
Fugl - Meyer Scale
Time frame: Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
Barthel Scale
Time frame: Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for STROKE
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Carlos Mario Andreani, MD study director
Fundación CENIT
Fabián César Piedimonte, MD principal investigator
Fundación CENIT - President
Questions about this trial
What is this clinical trial studying?
A study testing - Postoperative Antagonistic Peripheral Magnetic Stimulation, Selective Peripheral Magnetic Stimulation and Kinesics in people with STROKE, run by Juan Carlos M. Andreani MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Mario Andreani, MD (91150531392, jcmandreani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.