NCT03421509

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

January 28, 2018

Last Update Submit

July 1, 2018

Conditions

Stroke

Keywords

cutaneous silent periodspasticitystroke

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Day 1

Secondary Outcomes (14)

  • Modified Ashworth Scale wrist

    Day 1

  • Modified Ashworth Scale finger flexors

    Day 1

  • Modified Tardieu Scale R1 wrist

    Day 1

  • Modified Tardieu Scale R1 finger flexors

    Day 1

  • Modified Tardieu Scale R2 wrist

    Day 1

  • +9 more secondary outcomes

Interventions

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)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-70 years old patients with stroke will be allowed.

You may qualify if:

  • First ever time stroke
  • Time since stroke \>1 month
  • Being able to understand the instructions (mini mental test score\>24)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Floeter MK. Cutaneous silent periods. Muscle Nerve. 2003 Oct;28(4):391-401. doi: 10.1002/mus.10447.

    PMID: 14506711BACKGROUND

  • Gilio 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.

    PMID: 18242857BACKGROUND

  • Kwang-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

  • 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.

    PMID: 24284462BACKGROUND

MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulseren Derya AKYÜZ, Prof

    Marmara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Giray, MD

CONTACT

90 (216) 625 45 45esra.giray@marmara.edu.tr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2018

First Posted

February 5, 2018

Study Start

July 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

July 3, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)