Építés alatt – nem éles oldal
Belépés

NCT04002843Befejeződött

Variability of the Unique Fiber Potentials of a Spastic Muscle Treated With Botulinum Toxin

Jitter's Recording in a Spastic Muscle Treated by Botulinum Toxin

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 10.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The main objective is to study the variability and evolution of single-fiber jitter and fiber density (FD) electrophysiological parameters in a spastic muscle during botulinum toxin type A (BTA) treatment in hemiplegic patients after stroke, according to primary or multi-injected status. The secondary objectives of this study are: A. To establish a correlation between single-fibre electrophysiological parameters and the therapeutic response to BTA, clinically estimated by the MAS scale. B. Creation of a database on single fibre parameters to determine a Jitter numerical threshold beyond which the effect of BTA appears to be decreasing according to the clinical evaluation by the MAS (Modified Ashworth Scale).

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
40 (tényleges)
Első benyújtás
2019. jún. 27.
Kezdés
2019. aug. 30.
Elsődleges befejezés
2023. nov. 29.
Fő szponzor
Centre Hospitalier Universitaire de Nīmes
NCT-szám
NCT04002843

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 40
  • 2019. aug. 30. és az elsődleges befejezés (2023. nov. 29.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
  • The subject will be excluded if abnormalities will be found on prior EMG
    • Control Subjects :
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
  • The subject will be excluded if abnormalities will be found on prior EMG

Más betegség

  • Other upper limb disorders (bilateral stroke, peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy, severe osteoarthritis, recent muscle injury (s), recent bone, fracture, joint replacement)
  • Ongoing conditions contraindicating BTA treatment (especially respiratory disease)
  • Psychiatric disorders (other than anxiety disorder)
    • Stroke Patients :
  • Other upper limb disorders (bilateral stroke, peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy, severe osteoarthritis, recent muscle injury (s), recent bone, fracture, joint replacement)
  • Ongoing conditions contraindicating BTA treatment (especially respiratory disease)
  • Psychiatric disorders (other than anxiety disorder)
  • The subject has limb disorders (peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy)

Egyéb

  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • The subject is minor
  • The subject is under guardianship or curatorship
  • The subject has fixed retractions or bone deformities to the affected upper limb
  • Subjects with an intrathecal baclofen pump
  • Subjects with general anaesthesia scheduled within three months of treatment
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • The subject is minor
  • The subject is under guardianship or curatorship
  • The subject has fixed retractions or bone deformities to the affected upper limb
  • Subjects with an intrathecal baclofen pump
  • Subjects with general anaesthesia scheduled within three months of treatment
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • The subject is minor
  • The subject is under guardianship or curatorship

Kiket keres a vizsgálat

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is available for a follow-up of up to six months
  • Women and men are included
  • The patient is at least 18 years old
  • Subjects with upper limb spasticity involving the biceps brachial muscle, with a modified Ashworth score greater than or equal to 1, after hemorrhagic and/or ischemic stroke.
  • Patients will be voluntarily selected at three months of stroke to minimize the variability in single-fiber parameters caused by the central event itself
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is available for a follow-up of up to six months
  • Women and men are included
  • The patient is at least 18 years old
  • Subjects with upper limb spasticity involving one of elbow flexor muscle, with a modified Ashworth score greater than or equal to 1, after hemorrhagic and/or ischemic stroke.
  • Patients will be voluntarily selected at three months of stroke to minimize the variability in single-fiber parameters caused by the central event itself
  • The subject must have given their free and informed consent and signed the consent form
  • The subject must be a member or beneficiary of a health insurance plan
  • The subject should only be available on the day of recording
  • Women and men are included
  • The patient is at least 18 years old
  • They will be matched to stroke patient by age (+/- 5 years) and sex

A regiszterben nem jelölt feltételek

  • Stroke Patients :

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
CHU de NîmesNîmesFranciaországIsmeretlen állapot

Te vagy a koordinátor? Erősítsd meg az adatokat

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.