CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

⁃ 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

Locations
Other Locations
France
ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital
RECRUITING
Paris
ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Charlotte ROSSO, MD PhD
charlotte.rosso@aphp.fr
+33142162103
Backup
Isabelle LOUBINOUX, PhD
isabelle.loubinoux@inserm.fr
+33562746183
Time Frame
Start Date: 2024-12-13
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 45
Treatments
Active_comparator: tACS session 50 Hz
Three single sessions of tACS, each lasting 20 minutes, will be conducted 7-15 days apart, with a different frequency (50 or 70 Hz, corresponding to gamma oscillations) or a placebo frequency known as sham.
Active_comparator: tACS session 70 Hz
Three single sessions of tACS, each lasting 20 minutes, will be conducted 7-15 days apart, with a different frequency (50 or 70 Hz, corresponding to gamma oscillations) or a placebo frequency known as sham.
Sham_comparator: tACS Sham session
Three single sessions of tACS, each lasting 20 minutes, will be conducted 7-15 days apart, with a different frequency (50 or 70 Hz, corresponding to gamma oscillations) or a placebo frequency known as sham.
Related Therapeutic Areas
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov