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StrokeNCT05141695

Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation on Upper Extremity Spasticity After Stroke

A study testing therapeutic repetitive peripheral magnetic stimulation in people with Stroke, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Spasticity is a frequent problem in post-stroke patients. It can negatively affect the functional recovery of patients and impair their quality of life. The repetitive pulsed magnetic stimulation (rPMS) treatment has been shown to cause a reduction in muscle tone and improvement in activities of daily living in stroke… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
therapeutic repetitive peripheral magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2022to 15 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being diagnosed with stroke according to the definition of the World Health Organization (1989)
  • Being over 18 years old
  • Having a stroke confirmed by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)
  • Patients with spasticity between grade 1 and 3 according to the Modified Ashworth Scale (MAS) in the upper extremity arm/forearm muscle
  • Wellness of the patient's general condition after stroke

Who cannot join

  • Patients treated with botulinum toxin, phenol, alcohol injection for spasticity in the last 6 months
  • Patients who have previously undergone antispastic surgery to the treatment area
  • Patients with a change in oral antispastic drug use in the last 6 months
  • Patients with fixed contractures in the elbow and wrist
  • Patients with signs of acute inflammation in the treatment area
  • Patients with bleeding diathesis
Show all 12Show fewer
  • Patients with implanted devices (cardiac pacemaker, cochlear implant, drug pumps)
  • Patients with vascular problems such as deep vein thrombosis, phlebitis, varicose veins, arterial disease
  • Patients with a history of cancer in the treatment area
  • Pregnancy
  • Patients with metal implants in the treatment area
  • Patients with nonunion fractures at the treatment site

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara University Faculty of Medicine, Cebeci Hospital, Neurorehabilitation Clinic

    Ankara, 06340

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Repetitive Peripheral Magnetic Stimulation With Shearwave Ultrasound Elastography in Upper Extremity Spasticity After Stroke: a Randomized Controlled Trial

Spasticity is a frequent problem in post-stroke patients. It can negatively affect the functional recovery of patients and impair their quality of life. The repetitive pulsed magnetic stimulation (rPMS) treatment has been shown to cause a reduction in muscle tone and improvement in activities of daily living in stroke patients. So far, the effects of rPMS on muscle tone, which is the neurophysiological component of spasticity, have been evaluated, but its effects on the biomechanical component (soft tissue stiffness) have not been demonstrated. In this study, the effects of rPMS on soft tissue stiffness as well as increased muscle tone will be evaluated with clinical and ultrasound elastography in post-stroke patients with upper extremity spasticity.

Read the detailed description

The study is a randomized, double-blind, sham-controlled trial. Pos-stroke patients who applied to the Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation and developed upper extremity spasticity will be included in the study.

Patients included in the study will be randomized into two groups; treatment group and sham group. The block randomization will be preferred using the Random Allocation Software (RAS). 10 sessions of stretching exercises will be applied to all patients once a day, five sessions a week, with each session lasting 20 minutes. Patients in the treatment group will receive an additional peripheral magnetic stimulation therapy for the upper extremity arm/forearm spastic muscles on the hemiplegic side for a total of 10 sessions once a day, five sessions a week, for two weeks, each session lasting ten minutes. The patient will be seated in a chair. rPMS will not be given to the sham group, the device will not be operated, the probe of the device will be positioned in the same way as the patients in the treatment group for ten minutes, and the sounds recorded during the operation of the device will be heard by the patients. The patients and evaluators will not know which group the patients are in. rPMS treatment will be applied with the "BTL-6000 Super Inductive System Elite" in compliance with the recommendation by the manufacturer. The rPMS treatment parameters will be adjusted to use stimulus intensity above the motor threshold which is determined individually for each patient. Duration of each session will be 10 minutes.

Socio-demographic data such as gender, age, education level, occupation, background, duration of stroke, type of lesion, history of comorbidities and drugs used for spasticity including the botulinum toxin injection will be recorded. The patients will be evaluated three times; at the beginning, after the treatment (week 2) and two weeks after the end of the treatment.

Patients will be evaluated with the Fugl - Meyer Upper Extremity Motor Rating Scale, Modified Ashworth Scale (MAS) and Modified Tardieu Scale. Measurement of tissue stiffness will be made by shear wave elastography technique on the spastic upper extremity forearm/wrist flexor muscles of the affected side. Measurements will be made with the Siemens ACUSON S2000 Ultrasound System in kilopascals (kPa).

The Modified Ashworth Scale is considered the primary clinical measure of muscle spasticity. Hence it will be used as the primary outcome variable. Patients with severe spasticity (MAS stage 4) will not be included in the study. One unit decrease in MAS will be considered as clinically significant. Accordingly a power analysis yielded a sample size of 68 volunteers with 80% power and 5% margin of error. However, due to the nature of the study, it was planned to include a total of 76 volunteers, with an expected loss of 10%.

Conditions
Stroke
Being tested
therapeutic repetitive peripheral magnetic stimulation, sham repetitive peripheral magnetic stimulation
Keywords
Stroke, Spasticity, Magnetic stimulation, Ultrasound, Magnetotherapy
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.

  • therapeutic repetitive peripheral magnetic stimulationDevice

    Patients in the treatment group will receive peripheral magnetic stimulation therapy for the upper extremity arm/forearm spastic muscles on the hemiplegic side for a total of ten sessions once a day, five sessions a week, for two weeks, each session lasting ten minutes. Ten sessions of stretching exercises will be applied to all patients once a day, five sessions a week, with each session lasting 20 minutes.

  • sham repetitive peripheral magnetic stimulationDevice

    rPMS will not be given to the sham group, the device will not be operated, the probe of the device will be positioned in the same way as the patients in the treatment group for ten minutes, and the sounds recorded during the operation of the device will be heard by the patients. Patients and evaluators will not know which group the patients are in. Ten sessions of stretching exercises will be applied to all patients once a day, five sessions a week, with each session lasting 20 minutes.

Study groups in NCT05141695
Study groupRoleWhat they receive
therapeutic groupExperimentaltherapeutic repetitive peripheral magnetic stimulation
Receives: Device: therapeutic repetitive peripheral magnetic stimulation
sham groupSham comparatorsham repetitive peripheral magnetic stimulation
Receives: Device: sham repetitive peripheral magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Ashworth Scale

    The Modified Ashworth scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scores range from 0 to 4, where lower values represent normal muscle tone and higher values represent spasticity: 0: No increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3: Considerable increase in muscle tone, passive movement difficult; 4: Affected part(s) rigid in flexion or extension

    Measured: Change from baseline at 4 weeks

Secondary outcomes (3)
  1. Fugl - Meyer Upper Extremity Motor Rating Scale

    The Fugl - Meyer Upper Extremity Motor Rating Scale is a measure of upper-extremity motor weakness after stroke. It consists of 30 items assessing motor function and 3 items assessing reflex function. The 33 items that constitute the scale are scored on an ordinal scale of 0 (absent), 1 (partial impairment), and 2 (no impairment), resulting in a range of possible scores from 0 to 66. Lower values represent severe motor impairment, higher values represent mild motor impairment. The difference between R2 and R1 will be the measure of the dynamic component of spasticity.

    Measured: Change from baseline at 4 weeks

  2. Modified Tardieu Scale

    The Modified Tardieu Scale is used clinically to measure spasticity in patients with neurological conditions. It is differentiated into 3 parts and measures the passive range of motion (described as R2) at a stretching velocity as slow as possible (described as VI); grades the quality of muscle reaction to passive stretch at the fastest stretching velocity (described as V3); and 3) measures the angle of muscle reaction at the point of resistance to the fastest stretching velocity when the overactive stretch reflex produces a first catch (angle of muscle reaction; described as R1). The quality of muscle reaction was then rated at the fastest stretching velocity, and scores range from 0 to 5; 0 is no resistance to passive ROM to 5 indicating joint is immobile. The difference between R2 and R1 will be the measure of the dynamic component of spasticity.

    Measured: Change from baseline at 4 weeks

  3. Ultrasound elastography

    A method to measure tissue stiffness quantitatively.

    Measured: Change from baseline at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start1 Apr 2022
  3. Primary completion15 Jun 2024
  4. Study completion15 Jun 2024

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141695
Sponsor's protocol ID
16-681-21
Status last verified
Jan 2025
First submitted
24 Nov 2021
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.

    PubMed 27291521
  • Thibaut A, Chatelle C, Ziegler E, Bruno MA, Laureys S, Gosseries O. Spasticity after stroke: physiology, assessment and treatment. Brain Inj. 2013;27(10):1093-105. doi: 10.3109/02699052.2013.804202. Epub 2013 Jul 25.

    PubMed 23885710
  • Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.

    PubMed 7192811
  • Lieber RL, Roberts TJ, Blemker SS, Lee SSM, Herzog W. Skeletal muscle mechanics, energetics and plasticity. J Neuroeng Rehabil. 2017 Oct 23;14(1):108. doi: 10.1186/s12984-017-0318-y.

    PubMed 29058612
  • Bandholm T, Magnusson P, Jensen BR, Sonne-Holm S. Dorsiflexor muscle-group thickness in children with cerebral palsy: relation to cross-sectional area. NeuroRehabilitation. 2009;24(4):299-306. doi: 10.3233/NRE-2009-0482.

    PubMed 19597266
  • Ozturk A, Grajo JR, Dhyani M, Anthony BW, Samir AE. Principles of ultrasound elastography. Abdom Radiol (NY). 2018 Apr;43(4):773-785. doi: 10.1007/s00261-018-1475-6.

    PubMed 29487968
  • Vola EA, Albano M, Di Luise C, Servodidio V, Sansone M, Russo S, Corrado B, Servodio Iammarrone C, Caprio MG, Vallone G. Use of ultrasound shear wave to measure muscle stiffness in children with cerebral palsy. J Ultrasound. 2018 Sep;21(3):241-247. doi: 10.1007/s40477-018-0313-6. Epub 2018 Jul 20.

    PubMed 30030747
  • Krewer C, Hartl S, Muller F, Koenig E. Effects of repetitive peripheral magnetic stimulation on upper-limb spasticity and impairment in patients with spastic hemiparesis: a randomized, double-blind, sham-controlled study. Arch Phys Med Rehabil. 2014 Jun;95(6):1039-47. doi: 10.1016/j.apmr.2014.02.003. Epub 2014 Feb 19.

    PubMed 24561057

Questions about this trial

What is this clinical trial studying?

A study testing therapeutic repetitive peripheral magnetic stimulation in people with Stroke, run by Ankara University at 1 site in Turkey (Türkiye).

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 5 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Ashworth Scale (time frame: Change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05141695, which also lists 8 linked publications.

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 29 Jan 2025.

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