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Recruiting Not applicable

Cerebello-motor Neuromodulation After Stroke. CERSTIM.

NCT06599931 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-13
Last updated
2026-04-16

Condition(s) studied

StrokeHealthy

Investigational drug(s) / intervention(s)

tACS Transcranial alternating stimulation

tACS Transcranial alternating stimulation: session of 20 minutes

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • change in activation in the primary motor cortex and cerebellum using functional magnetic Resonance — [Time Frame: within 1 hour before and after the intervention]
    The activity of cerebellomotor regions is measured in functional task MRI with a hand motor task performed in the machine (squeezing a handle). The average BOLD signal in the cerebellum and M1 regions is measured using a general linear model adapted to functional MRI images such as SPM and its toolboxes.

Trial sites (2)

FacilityCityRegionStatus
ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital Paris France Recruiting
ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot Toulouse France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06599931 on ClinicalTrials.gov ↗ ← All trials in France