Cerebello-motor Neuromodulation After Stroke. CERSTIM.

Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Sep 12, 2024

Keywords

ClinConnect Summary

The CERSTIM study is looking at a new treatment method called transcranial alternating current stimulation (tACS) to see how it affects movement in people who have had a stroke. This study focuses on the connections between different parts of the brain involved in movement. Researchers will test different frequencies of stimulation and compare the results to a placebo, which is like a sugar pill that has no real effect. Participants will include both stroke patients and healthy individuals, and the study will gather information through brain scans and other tests to understand how tACS works.

To participate in this study, stroke patients need to be at least 18 years old and have experienced a stroke more than six months ago that has left them with some movement difficulties in their upper limbs. They should not have total paralysis of the affected hand or conditions that would prevent them from following the study's procedures. Healthy volunteers are also welcome, as long as they meet similar age and health criteria. Throughout the study, participants can expect to undergo various assessments, including brain imaging and movement tests, to help researchers learn more about the effects of this treatment. If you're interested in participating, it's important to discuss any health conditions or concerns with the study team to see if you qualify.

Gender

ALL

Eligibility criteria

• • 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