Cerebello-motor Neuromodulation After Stroke. CERSTIM.

NCT06599931 | Recruiting

• 2 other identifiers: C23-1002024-A00623-44
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke; Healthy

Outcome Measures

Primary Outcomes (1)

• change in activation in the primary motor cortex and cerebellum using functional magnetic Resonance

  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.

  [Time Frame: within 1 hour before and after the intervention]

Secondary Outcomes (5)

• comparison between activation in the primary motor cortex and cerebellum using functional magnetic Resonance with the 50 Htz versus the 70 Htz frequency

  [Time Frame: within 1 hour before and after the intervention]

• change in functional connectivity between the primary motor cortex and cerebellum using functional magnetic Resonance

  [Time Frame: within 1 hour before and after the intervention]

• change in functional connectivity using EEG after intervention and comparison between frequencies of tACS

  [Time Frame: within 1 hour before and after the intervention]

• change in behaviour after intervention and comparison between frequencies of tACS

  [Time Frame: within 1 hour before and after the intervention]

• comparison of the prespecified patients outcome with those of healthy subjects

  [Time Frame: within 1 hour before and after the intervention]

Study Arms (3)

tACS session 50 Hz

ACTIVE COMPARATOR

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."

Device: tACS Transcranial alternating stimulation

tACS session 70 Hz

ACTIVE COMPARATOR

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."

Device: tACS Transcranial alternating stimulation

tACS Sham session

SHAM COMPARATOR

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."

Device: tACS Transcranial alternating stimulation

Interventions

tACS Transcranial alternating stimulation DEVICE

session of 20 minutes

tACS Sham session; tACS session 50 Hz; tACS session 70 Hz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \-- 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)
• HEALTHY
• 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)

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (2)

ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital

Paris, 75013, France

RECRUITING

ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot

Toulouse, 31300, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charlotte ROSSO, MD PHD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte ROSSO, MD PhD

CONTACT

+33142162103; charlotte.rosso@aphp.fr

Isabelle LOUBINOUX, PhD

CONTACT

+33562746183; isabelle.loubinoux@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded from the type of intervention (sham, 50 Htz or 70 Htz)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Three sessions active tACS 20 minutes, 50Htz active tACS 20 minutes, 70 Htz sham Order will be randomized

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (2)