RECRUITINGINTERVENTIONAL
Cerebello-motor Neuromodulation After Stroke. CERSTIM.
CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE
About This Trial
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 frequencies in the gamma band and one placebo. We will use behavioural data, functional MRI, and Electroencephalography to disentangle the effect of tACS and its frequency. Healthy participants will be also recruited.
Who May Be Eligible (Plain English)
PATIENTS
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
\-- 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
Who May Qualify:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
PATIENTS
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.
* 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 Criteria:
\-- 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
Treatments Being Tested
DEVICE
tACS Transcranial alternating stimulation
session of 20 minutes
Locations (2)
ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital
Paris, France
ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot
Toulouse, France