RecruitingNot ApplicableNCT06599931

Cerebello-motor Neuromodulation After Stroke. CERSTIM.

CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE


Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

45 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • 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.
  • 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.
  • \-- 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

Exclusion Criteria6

  • \-- 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

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Interventions

DEVICEtACS 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

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NCT06599931


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