Status:
RECRUITING
Cerebello-motor Neuromodulation After Stroke. CERSTIM.
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Stroke
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The CERSTIM study is a physiopatholgical study investigating transcranial alternating current stimulation in stroke patients in the cerebello-motor loop. The design is a cross over design testing two...
Detailed Description
Neuromodulation, by the means of Non-Invasive Brain Stimulation techniques, is a promising method to enhance motor recovery of the upper limb following a stroke. However, none of these techniques have...
Eligibility Criteria
Inclusion
- PATIENTS
- Male or female aged 18 years or older on the day of inclusion.
- Affiliated with a social security system, Universal Health Coverage (CMU), or any equivalent scheme.
- Ischemic stroke or intraparenchymal hematoma that occurred more than 6 months ago, with no upper time limit.
- Motor deficit of the upper limb confirmed by the ARAT scale, with the ability to grip and press on a tablet.
- stroke lesion not affecting the motor cortex in the hand knob area.
Exclusion
- \-- Pregnant and breastfeeding women
- Total paralysis of the affected hand
- Conditions that are life-threatening or could compromise follow-up during the study period
- Contraindications to MRI and tACS (ferromagnetic surgical clips, ocular implants, intraocular or nervous system metallic foreign bodies, implants or metallic objects likely to concentrate the radiofrequency field, cochlear implants, brain or cardiac stimulators, presence of a craniotomy scar)
- Participation in another biomedical study focused on motor or overall recovery during the same period, or current exclusion period from another biomedical study
- HEALTHY
- Inclusion Criteria:
- Male or female aged 18 years or older on the day of inclusion.
- Affiliated with a social security system, Universal Health Coverage (CMU), or any equivalent scheme.
- Non inclusion criteria
- \-- Pregnant and breastfeeding women
- Conditions that are life-threatening or could compromise follow-up during the study period
- Contraindications to MRI and tACS (ferromagnetic surgical clips, ocular implants, intraocular or nervous system metallic foreign bodies, implants or metallic objects likely to concentrate the radiofrequency field, cochlear implants, brain or cardiac stimulators, presence of a craniotomy scar)
- Participation in another biomedical study during the same period, or current exclusion period from another biomedical study
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06599931
Start Date
December 13 2024
End Date
December 30 2027
Last Update
March 25 2025
Active Locations (2)
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1
ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital
Paris, France, 75013
2
ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot
Toulouse, France, 31300