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.
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
- Betegségek
- Stroke (szélütés)
- 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.
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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
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHU de Nîmes | Nîmes | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.