Trial · NCT05222828
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | improvement of clinical scores | 1 Day | The response is defined as an improvement 1h (+/- 30min) after injection, compared to the evaluation before mepivacaine injection, on at least one of the clinical scores specific to the symptoms: * language : decrease of at least 4 points on the ART scale (rated from 0 to 26) , or increase of 20% of the number of images correctly named on a standardized battery (DO80, rated from 0 to 80). The rate of 20% corresponds to an effect considered clinically significant, without any "clinically significant minimal change" published to date. * motor skills : increase of at least 4 points on the Fugl-Meyer scale (rated from 0 to 60) corresponding to the "clinically significant minimal change" in the re-education studies * visual field : 20% reduction of a scotoma evaluated in automated static perimetry of Humphrey by the number of deficit areas compared to the total number of areas evaluated (n=43). The rate of 20% corresponds to an effect considered clinically significant |
| Secondary | language-related symptoms | 1 Day | Relative change, in percentage, in the number of correctly named images on a standardized battery (DO80, rated from 0 to 80) between pre- and 1h(+/-30min) post-injection to measure language-related symptoms. |
| Secondary | ART scale | 1 Day | Absolute change, in number of points, on the ART scale (rated from 0 to 26) between before and 1h(+/-30min) after injection to measure language-related symptoms. |
| Secondary | spontaneous language test | 1 Day | Relative change, of he rate from 0 to 10 at the spontaneous language test between before and 1h(+/-30min) after injection to measure language-related symptoms. |
| Secondary | Fugl-Meyer scale | 1Day | Absolute change, in number of points, on the Fugl-Meyer scale (rated from 0 to 60), between before and 1h(+/-30min) after injection to measure motor symptoms. |
| Secondary | Timed up and go test | 1Day | relative change, on the Timed up and go test (TUG) (rated in seconds), between before and 1h(+/-30min) after injection to measure motor symptoms. |
| Secondary | 10 metres walking test | 1Day | Relative change, on the 10 metres walking test (rated in seconds), between before and 1h(+/-30min) after injection to measure motor symptoms. |
| Secondary | Perimetry of Humphrey | 1 Day | Relative evolution of visual symptoms, measured in automated static perimetry of Humphrey (STAT-30, Metrovision) by the number of deficit areas compared to the total number of assessed areas (n=43), between before and 1h (+/-30min) after injection |
| Secondary | kinetic perimetry | 1 Day | Relative evolution of visual symptoms, measured in kinetic perimetry by the surface of isoptera III/4, between before and 1h (+/-30min) after injection. |
| Secondary | static perimetry | 1 Day | Evolution of visual deficit volumes, measured in static perimetry in dB.deg2, between before and 1h (+/-30min) after injection. |
| Secondary | NIHSS score changes | 1 Day | Change in severity of neurological sequelae measured by the relative change in the National Institutes of Health Stroke Scale (NIHSS score) between before and 1h(+/-30min) after injection. |
| Secondary | response delay | 1 Day | Patient Reported Response Start and End Times |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05222828/registered