StrokeCERSTIMNCT06599931
Cerebello-motor Neuromodulation After Stroke. CERSTIM.
A study testing tACS Transcranial alternating stimulation in people with Stroke and Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- tACS Transcranial alternating stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Dec 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- -- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
ICM_ Institut du Cerveau et de la Moelle épinière, Hôpital Pitié, 47 Bd de l'Hôpital
Paris, 75013
Charlotte MD ROSSO, +33 1 42 16 18 54, charlotte.rosso@aphp.fr
- Not yet recruiting
ToNIC - Toulouse neuro Imaging center (Inserm)Pavillon Baudot
Toulouse, 31300
Isabelle LOUBINOUX, 05.62.74.61.84, isabelle.loubinoux@inserm.fr
Phillippe MD MARQUE
About this study
Official title: CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE
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.
Read the detailed description
Neuromodulation, by the means of Non-Invasive Brain Stimulation techniques, is a promising method to enhance motor recovery of the upper limb following a stroke. However, none of these techniques have yet been effectively transferred to the patient's bedside. An international group of experts has examined this issue, identifying barriers that need to be overcome for successful transferability. Among their findings, two were particularly emphasized: (i) the insufficient characterization of the mechanisms through which these stimulations are effective, and (ii) the comparison of stimulation parameters before moving on to larger samples. We have decided to use this model to study tACS (transcranial Alternating Current Stimulation) on the cerebellomotor network.
The choice of tACS is justified by (i) its ability to "entrain" a neural network through its oscillations, (ii) its innovative nature, and (iii) its "wearable" characteristic, making it quickly transferable. The choice of the cerebellomotor network is based on literature data showing that (i) the cerebellum plays a crucial role in motor learning in healthy individuals (which is one of the substrates of post-stroke recovery), and (ii) cerebellomotor synchronization is a good prognostic indicator for the recovery of hand motor function.
In light of these findings, we have decided to conduct a pathophysiological, bi-centric study to determine the cerebral mechanisms by which tACS acts on the cerebellomotor network. 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." To understand the cerebral mechanisms, we will use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG). We will also examine a behavioral motor adaptation task on a tablet. The order in which the three frequencies are applied will be randomized This study will include 30 patients and 15 healthy subjects. The patients will be individuals who have suffered a stroke more than 6 months ago, resulting in a hand deficit without complete paralysis. The healthy controls will serve as a reference for mechanisms and imaging/electrophysiology data.
We hypothesize the following: The mechanisms involved following cerebellomotor stimulation could include a modification of brain rhythms in the beta or gamma band during movement, an increase in activity in the primary motor cortex, or a change in the excitation-inhibition balance between the cerebellum and the primary motor cortex, or directly at the level of the primary motor cortex. These different mechanisms may vary depending on the frequency used.
This research is part of the NEUROTECH Impulse Program managed by INSERM.
- Being tested
- tACS Transcranial alternating stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS Transcranial alternating stimulationDevice
session of 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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." Receives: 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." Receives: Device: tACS Transcranial alternating stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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
The measurement method is identical to that used for the primary endpoint. Only the final statistical test changes (comparison of differences between each session).
final change statistics (comparison of difference between each session).
Measured: [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
The measurement method is based on functional task MRI. It involves a z-score of the correlation between the signal of 2 regions in time belonging to the motor network.
Measured: [Time Frame: within 1 hour before and after the intervention]
change in functional connectivity using EEG after intervention and comparison between frequencies of tACS
The measurement method will be functional connectivity measured by an index called wSMI (weighted-Symbolic Mutual Information), which is an EEG marker. EEG data will be collected via the Starstim Neuroelectrics system and analyzed using in-house scripts (developed in-house) in Matlab and Python before and after each session, and we will also compare differences in change between the two sessions.
Measured: [Time Frame: within 1 hour before and after the intervention]
change in behaviour after intervention and comparison between frequencies of tACS
behaviour will be assessed on a motor learning task (accuracy, reaction time). The measurement method will be a SRT (serial reaction time) task with visuomotor adaptation where the subject must obey these instructions. Error rate and reaction time will be measured.
will be measured.
Measured: [Time Frame: within 1 hour before and after the intervention]
comparison of the prespecified patients outcome with those of healthy subjects
All the above measurements will be carried out in a cohort of healthy subjects and compared with patients.
Measured: [Time Frame: within 1 hour before and after the intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Dec 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three sessions active tACS 20 minutes, 50Htz active tACS 20 minutes, 70 Htz sham Order will be randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Charlotte ROSSO, MD PHD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599931
- Sponsor's protocol ID
- C23-100
- Other IDs
- 2024-A00623-44
- Acronym
- CERSTIM
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD could be shared upon request and if RGPD rules are respected and if ethics comittee agrees
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE
- ClinicalTrials.gov ID
- NCT06599931
- Acronym / sponsor ID
- CERSTIM / C23-100
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuromodulation, by the means of Non-Invasive Brain Stimulation techniques, is a promising method to enhance motor recovery of the upper limb following a stroke. However, none of these techniques have yet been effectively transferred to the patient's bedside. An international group of experts has examined this issue, identifying barriers that need to be overcome for successful transferability. Among their findings, two were particularly emphasized: (i) the insufficient characterization of the mechanisms through which these stimulations are effective, and (ii) the comparison of stimulation parameters before moving on to larger samples. We have decided to use this model to study tACS (transcranial Alternating Current Stimulation) on the cerebellomotor network.
The choice of tACS is justified by (i) its ability to "entrain" a neural network through its oscillations, (ii) its innovative nature, and (iii) its "wearable" characteristic, making it quickly transferable. The choice of the cerebellomotor network is based on literature data showing that (i) the cerebellum plays a crucial role in motor learning in healthy individuals (which is one of the substrates of post-stroke recovery), and (ii) cerebellomotor synchronization is a good prognostic indicator for the recovery of hand motor function.
In light of these findings, we have decided to conduct a pathophysiological, bi-centric study to determine the cerebral mechanisms by which tACS acts on the cerebellomotor network. 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." To understand the cerebral mechanisms, we will use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG). We will also examine a behavioral motor adaptation task on a tablet. The order in which the three frequencies are applied will be randomized This study will include 30 patients and 15 healthy subjects. The patients will be individuals who have suffered a stroke more than 6 months ago, resulting in a hand deficit without complete paralysis. The healthy controls will serve as a reference for mechanisms and imaging/electrophysiology data.
We hypothesize the following: The mechanisms involved following cerebellomotor stimulation could include a modification of brain rhythms in the beta or gamma band during movement, an increase in activity in the primary motor cortex, or a change in the excitation-inhibition balance between the cerebellum and the primary motor cortex, or directly at the level of the primary motor cortex. These different mechanisms may vary depending on the frequency used.
This research is part of the NEUROTECH Impulse Program managed by INSERM.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three sessions active tACS 20 minutes, 50Htz active tACS 20 minutes, 70 Htz sham Order will be randomized
| Arm | Type | Receives |
|---|---|---|
| tACS session 50 Hz | Active comparator | Device: tACS Transcranial alternating stimulationThree 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." |
| tACS session 70 Hz | Active comparator | Device: tACS Transcranial alternating stimulationThree 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." |
| tACS Sham session | Sham comparator | Device: tACS Transcranial alternating stimulationThree 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." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- -- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACS Transcranial alternating stimulationsession of 20 minutes | Device | tACS Sham session, tACS session 50 Hz, tACS session 70 Hz |
Primary outcome
change in activation in the primary motor cortex and cerebellum using functional magnetic Resonance
Time frame: [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.
5 secondary outcomes
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: [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: [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: [Time Frame: within 1 hour before and after the intervention]
change in behaviour after intervention and comparison between frequencies of tACS
Time frame: [Time Frame: within 1 hour before and after the intervention]
comparison of the prespecified patients outcome with those of healthy subjects
Time frame: [Time Frame: within 1 hour before and after the intervention]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided. IPD could be shared upon request and if RGPD rules are respected and if ethics comittee agrees
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte ROSSO, MD PHD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS Transcranial alternating stimulation in people with Stroke and Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte ROSSO, MD PhD (+33142162103, charlotte.rosso@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in activation in the primary motor cortex and cerebellum using functional magnetic Resonance (time frame: [Time Frame: within 1 hour before and after the intervention]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.