StrokeNCT03421509
Cutaneous Silent Period and Spasticity
An observational study of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows a noxious cutaneous nerve stimulation. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- cutaneous silent period
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Feb 2019
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-70 years old patients with stroke will be allowed.
Who may be able to join
- First ever time stroke
- Time since stroke >1 month
- Being able to understand the instructions (mini mental test score>24)
Who cannot join
- Diseases which might affect CSP parameters (Parkinsonism, restless leg syndrome, carpal tunel syndrome etc.)
- Autonomic nervous system disease
- Antispasticity medication use
- Hemiplegic shoulder pain
- Botulinum toxin injection within 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
Giray Esra, MD, +905558134394, girayesra@hotmail.com
MD
About this study
Official title: The Association Between Cutaneous Silent Period Parameters and Spasticity in Patients With Stroke
The cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows a noxious cutaneous nerve stimulation. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex. The aim of this study is to investigate the association between CSP parameters (duration and latency) and spasticity in stroke.
Read the detailed description
The cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows a noxious cutaneous nerve stimulation. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex. Spasticity is a serious problem that creates great difficulty for both patients and clinicians. The Support Programme for Assembly of a database for Spasticity Measurement (SPASM) group defined the spasticity as "disordered sensory-motor control, resulting from an upper motor neuron lesion, presenting as intermittent or sustained involuntary activation of muscles". Spasticity occurs in different types depending on the duration of the lesion present in the central nervous system (acute or slowly emerging), the size of the lesion and the location of the lesion such as cerebral cortex, brain stem or spinal cord. There are three major approaches, clinical, neurophysiological and biomechanical, for assessing spasticity. Stimulating the cutaneous nerve of the index finger at low-intensity, researchers have evoked an inhibition of the electromyographic (EMG) activity with a long latency and a short duration, namely the I2 inhibitory response of the cutaneo-muscular reflexes in the hand. ıt was suggested that the I2 inhibitory response, whose latency and duration overlap the CSP, was mediated by low-threshold, large-diameter fibers. Hence, because high-intensity electrical stimuli used to evoke the CSP activate large-diameter as well as small-diameter fibers, both fiber types may contribute in generating the CSP .
The central neural substrates producing the alpha-motor neuron inhibition after high-intensity stimulation differ from those after low-intensity stimulation. Low-intensity non-painful stimulation elicits a typical polysynaptic pattern of exteroceptive reflexes, whereas high-intensity electrical stimulation elicits an oligosynaptic pattern. Several studies investigated whether the CSP after high intensity finger stimulation arises from interruption of the excitatory drive to motor neurons (pre-synaptic inhibition) or inhibition of motor neurons themselves (post-synaptic inhibition). Studies using H-reflexes, F waves, and motor evoked potentials to assess motor neuron excitability showed that during the CSP motor neurons mainly receive post-synaptic inhibition transmitted through spinal inhibitory interneurons. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex.
It was investigated whether the CSP parameters, F parameters are different between patients with stroke and amyotrophic lateral sclerosis (ALS) and healthy controls.
They found that CSP latency was higher in patients with stroke and ALS than healthy subjects. There was no difference in KSP duration and F-latency compared to healthy subjects. Contrary to these results, in another study did not show a relationship between spasticity and CSP parameters in twelve patients with stroke. The results of the existing studies on the relationship between spasticity and CSP parameters are conflicting. The influence of the descending suprasegmental pathways on the origin of the CSP is yet to be elucidated. Therefore; there is a need for a properly designed study investigating this relationship in a homogeneous sample. Given these results, we aimed to investigate the association between CSP parameters (duration and latency) and spasticity in patients with stroke. modified Ashworth scale, Modified Tardieu scale, Brunnstrom motor stage ve Fugl Meyer upper extremity score, Barthel index will be measured. Patients with stroke will underwent electromyographic assessments of F-wave latency, F-M ratio, CSP latency and duration, upper extremity nerve conduction studies. Association between clinical assessments and electrophysiological assessments will be investigated.
- Conditions
- Stroke
- Being tested
- cutaneous silent period
- Keywords
- cutaneous silent period, 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.
cutaneous silent periodOther
In the upper limb the cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows painful stimulation applied to the finger (digits II-V, C6-C8 dermatomes)
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous silent period latency (ms)
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve. time between the stimulation and beginning of the silent period.
Measured: Day 1
Cutaneous silent period duration (ms)
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve. CSP duration is defined as the time between the beginning and endpoint of the silent period
Measured: Day 1
Secondary outcomes (14)
Modified Ashworth Scale wrist
Scores range from 0-4, with 5 choices 0 (0) - No increase in muscle tone 1 (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+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: Day 1
Modified Ashworth Scale finger flexors
Scores range from 0-4, with 5 choices 0 (0) - No increase in muscle tone 1 (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+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: Day 1
Modified Tardieu Scale R1 wrist
The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle
Measured: Day 1
Modified Tardieu Scale R1 finger flexors
The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle
Measured: Day 1
Modified Tardieu Scale R2 wrist
The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle
Measured: Day 1
Modified Tardieu Scale R2 finger flexors
The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle
Measured: Day 1
Modified Tardieu Scale R2-R1 wrist
The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle
Measured: Day 1
Modified Tardieu Scale R2-R1 finger flexors
The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle
Measured: Day 1
Brunnstrom stage arm
Motor recovery stage after stroke The Seven Brunnstrom Stages of Motor Recovery (see table below for more details)
- Flaccid paralysis. No reflexes.
- Some spastic tone. No voluntary movement. Synergies elicited through facilitation.
- Spasticity is marked. Synergistic movements may be elicited voluntarily.
- Spasticity decreases. Synergistic movements predominate.
- Spasticity wanes. Can move out of synergies although synergies still present.
- Coordination and movement patterns near normal. Trouble with more rapid complex movements.
- Normal.
Measured: Day 1
Brunnstrom stage hand
Motor recovery stage after stroke The Seven Brunnstrom Stages of Motor Recovery (see table below for more details)
- Flaccid paralysis. No reflexes.
- Some spastic tone. No voluntary movement. Synergies elicited through facilitation.
- Spasticity is marked. Synergistic movements may be elicited voluntarily.
- Spasticity decreases. Synergistic movements predominate.
- Spasticity wanes. Can move out of synergies although synergies still present.
- Coordination and movement patterns near normal. Trouble with more rapid complex movements.
- Normal.
Measured: Day 1
Fugl Meyer upper extremity score
Items are scored on a 3-point ordinal scale 0 = cannot perform
- = performs partially
- = performs fully Maximum score=66
Measured: Day 1
Barthel index
ordinal scale used to measure performance in activities of daily living (ADL) Minimum-maximum score: 0-100
Measured: Day 1
F wave latency
the time from the onset of the stimulation artifact to the first deflection of the waveform from baseline <32 ms when obtained from median/ulnar nerves
Measured: Day 1
F/M ratio
The F/M ratio compares proximal and distal segments and is useful in evaluating conduction time from stimulation site to spinal cord
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulseren Derya AKYÜZ, Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421509
- Sponsor's protocol ID
- 09.2017.679
- Status last verified
- Jul 2018
- First submitted
- 28 Jan 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Floeter MK. Cutaneous silent periods. Muscle Nerve. 2003 Oct;28(4):391-401. doi: 10.1002/mus.10447.
PubMed 14506711Gilio F, Bettolo CM, Conte A, Iacovelli E, Frasca V, Serrao M, Giacomelli E, Gabriele M, Prencipe M, Inghilleri M. Influence of the corticospinal tract on the cutaneous silent period: a study in patients with pyramidal syndrome. Neurosci Lett. 2008 Mar 12;433(2):109-13. doi: 10.1016/j.neulet.2007.12.055. Epub 2008 Jan 10.
PubMed 18242857Kwang-Ik Jung WK. The Relationship between Cutaneous Silent Period and Spasticity in Patients with Stroke. Jouranl of Korean Association of EMG Electrodiagnostic Medicine, 10( 1), 1- 5. 2008.
Naghdi S, Ansari NN, Abolhasani H, Mansouri K, Ghotbi N, Hasson S. Electrophysiological evaluation of the Modified Tardieu Scale (MTS) in assessing poststroke wrist flexor spasticity. NeuroRehabilitation. 2014;34(1):177-84. doi: 10.3233/NRE-131016.
PubMed 24284462
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Cutaneous Silent Period Parameters and Spasticity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03421509
- Acronym / sponsor ID
- 09.2017.679
- Conditions
- Stroke
- Keywords
- cutaneous silent period, spasticity, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 5 Feb 2018 (actual)
- 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 cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows a noxious cutaneous nerve stimulation. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex. The aim of this study is to investigate the association between CSP parameters (duration and latency) and spasticity in stroke.
Detailed description
The cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows a noxious cutaneous nerve stimulation. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex. Spasticity is a serious problem that creates great difficulty for both patients and clinicians. The Support Programme for Assembly of a database for Spasticity Measurement (SPASM) group defined the spasticity as "disordered sensory-motor control, resulting from an upper motor neuron lesion, presenting as intermittent or sustained involuntary activation of muscles". Spasticity occurs in different types depending on the duration of the lesion present in the central nervous system (acute or slowly emerging), the size of the lesion and the location of the lesion such as cerebral cortex, brain stem or spinal cord. There are three major approaches, clinical, neurophysiological and biomechanical, for assessing spasticity. Stimulating the cutaneous nerve of the index finger at low-intensity, researchers have evoked an inhibition of the electromyographic (EMG) activity with a long latency and a short duration, namely the I2 inhibitory response of the cutaneo-muscular reflexes in the hand. ıt was suggested that the I2 inhibitory response, whose latency and duration overlap the CSP, was mediated by low-threshold, large-diameter fibers. Hence, because high-intensity electrical stimuli used to evoke the CSP activate large-diameter as well as small-diameter fibers, both fiber types may contribute in generating the CSP .
The central neural substrates producing the alpha-motor neuron inhibition after high-intensity stimulation differ from those after low-intensity stimulation. Low-intensity non-painful stimulation elicits a typical polysynaptic pattern of exteroceptive reflexes, whereas high-intensity electrical stimulation elicits an oligosynaptic pattern. Several studies investigated whether the CSP after high intensity finger stimulation arises from interruption of the excitatory drive to motor neurons (pre-synaptic inhibition) or inhibition of motor neurons themselves (post-synaptic inhibition). Studies using H-reflexes, F waves, and motor evoked potentials to assess motor neuron excitability showed that during the CSP motor neurons mainly receive post-synaptic inhibition transmitted through spinal inhibitory interneurons. Studies in patients with central disorders of motor control such as dystonia and Parkinson's disease have shown CSP abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex.
It was investigated whether the CSP parameters, F parameters are different between patients with stroke and amyotrophic lateral sclerosis (ALS) and healthy controls.
They found that CSP latency was higher in patients with stroke and ALS than healthy subjects. There was no difference in KSP duration and F-latency compared to healthy subjects. Contrary to these results, in another study did not show a relationship between spasticity and CSP parameters in twelve patients with stroke. The results of the existing studies on the relationship between spasticity and CSP parameters are conflicting. The influence of the descending suprasegmental pathways on the origin of the CSP is yet to be elucidated. Therefore; there is a need for a properly designed study investigating this relationship in a homogeneous sample. Given these results, we aimed to investigate the association between CSP parameters (duration and latency) and spasticity in patients with stroke. modified Ashworth scale, Modified Tardieu scale, Brunnstrom motor stage ve Fugl Meyer upper extremity score, Barthel index will be measured. Patients with stroke will underwent electromyographic assessments of F-wave latency, F-M ratio, CSP latency and duration, upper extremity nerve conduction studies. Association between clinical assessments and electrophysiological assessments will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-70 years old patients with stroke will be allowed.
Key inclusion criteria (3 listed)
- First ever time stroke
- Time since stroke >1 month
- Being able to understand the instructions (mini mental test score>24)
Key exclusion criteria (5 listed)
- Diseases which might affect CSP parameters (Parkinsonism, restless leg syndrome, carpal tunel syndrome etc.)
- Autonomic nervous system disease
- Antispasticity medication use
- Hemiplegic shoulder pain
- Botulinum toxin injection within 6 months
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 |
|---|---|---|
| cutaneous silent periodIn the upper limb the cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows painful stimulation applied to the finger (digits II-V, C6-C8 dermatomes) | Other | – |
Primary outcome
Cutaneous silent period latency (ms)
Time frame: Day 1
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve. time between the stimulation and beginning of the silent period.
Cutaneous silent period duration (ms)
Time frame: Day 1
the brief interruption in voluntary contraction that follows strong electrical stimulation (painful) of a cutaneous nerve. CSP duration is defined as the time between the beginning and endpoint of the silent period
14 secondary outcomes
Modified Ashworth Scale wrist
Time frame: Day 1
Modified Ashworth Scale finger flexors
Time frame: Day 1
Modified Tardieu Scale R1 wrist
Time frame: Day 1
Modified Tardieu Scale R1 finger flexors
Time frame: Day 1
Modified Tardieu Scale R2 wrist
Time frame: Day 1
Modified Tardieu Scale R2 finger flexors
Time frame: Day 1
Modified Tardieu Scale R2-R1 wrist
Time frame: Day 1
Modified Tardieu Scale R2-R1 finger flexors
Time frame: Day 1
Brunnstrom stage arm
Time frame: Day 1
Brunnstrom stage hand
Time frame: Day 1
Fugl Meyer upper extremity score
Time frame: Day 1
Barthel index
Time frame: Day 1
F wave latency
Time frame: Day 1
F/M ratio
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 14506711Floeter MK. Cutaneous silent periods. Muscle Nerve. 2003 Oct;28(4):391-401. doi: 10.1002/mus.10447.
- Background: PubMed 18242857Gilio F, Bettolo CM, Conte A, Iacovelli E, Frasca V, Serrao M, Giacomelli E, Gabriele M, Prencipe M, Inghilleri M. Influence of the corticospinal tract on the cutaneous silent period: a study in patients with pyramidal syndrome. Neurosci Lett. 2008 Mar 12;433(2):109-13. doi: 10.1016/j.neulet.2007.12.055. Epub 2008 Jan 10.
- BackgroundKwang-Ik Jung WK. The Relationship between Cutaneous Silent Period and Spasticity in Patients with Stroke. Jouranl of Korean Association of EMG Electrodiagnostic Medicine, 10( 1), 1- 5. 2008.
- Background: PubMed 24284462Naghdi S, Ansari NN, Abolhasani H, Mansouri K, Ghotbi N, Hasson S. Electrophysiological evaluation of the Modified Tardieu Scale (MTS) in assessing poststroke wrist flexor spasticity. NeuroRehabilitation. 2014;34(1):177-84. doi: 10.3233/NRE-131016.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gulseren Derya AKYÜZ, Prof principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Marmara 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 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: status not confirmed, as of the sponsor's last update on 3 Jul 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Giray, MD (90 (216) 625 45 45 ext. 1611, esra.giray@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous silent period latency (ms) (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT03421509, which also lists 4 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 3 Jul 2018.