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Upper-limb Active Function and Botulinum Toxin A

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518147-37-00
Acronym
RC31/17/0455
Enrollment
80
Registered
2024-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

Measurement of the spastic cocontraction index (ICCS) during active elbow extension movement, obtained from the EMG signal of the elbow extensor and flexor muscles on the paretic side, between T1 and T2 (before versus 4 weeks after TBA injection)

Detailed description

Spasticity of the elbow flexors according to Tardieu, Limitation of the active movement angle (LAMA) of elbow extension, Fugl-Meyer score (motor selectivity), Functional abilities with the Wolf Motor Function Test (WMFT) score, EEG quantification of bilateral cortical activity during movement (real or imagined) to calculate the following indices: o desynchronization index (ERD) identifying hyperactivity in the ipsilesional cortex; o synchronization index quotient (ERS) to assess interhemispheric inhibition (inhibition laterality coefficient) o amount of interhemispheric coherence, Corticospinal excitability (curve of variation of MEP amplitude as a function of stimulation intensity) assessed by TMS, Anatomical lesions of the motor pathways (motor cortex and descending motor pathways) obtained from anatomical (T1) and diffusion-weighted MRI

Interventions

DRUGpoudre pour solution injectable

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Measurement of the spastic cocontraction index (ICCS) during active elbow extension movement, obtained from the EMG signal of the elbow extensor and flexor muscles on the paretic side, between T1 and T2 (before versus 4 weeks after TBA injection)

Secondary

MeasureTime frame
Spasticity of the elbow flexors according to Tardieu, Limitation of the active movement angle (LAMA) of elbow extension, Fugl-Meyer score (motor selectivity), Functional abilities with the Wolf Motor Function Test (WMFT) score, EEG quantification of bilateral cortical activity during movement (real or imagined) to calculate the following indices: o desynchronization index (ERD) identifying hyperactivity in the ipsilesional cortex; o synchronization index quotient (ERS) to assess interhemispheric inhibition (inhibition laterality coefficient) o amount of interhemispheric coherence, Corticospinal excitability (curve of variation of MEP amplitude as a function of stimulation intensity) assessed by TMS, Anatomical lesions of the motor pathways (motor cortex and descending motor pathways) obtained from anatomical (T1) and diffusion-weighted MRI

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026