StrokePhase 2BrainSpineStimNCT07334977
Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation
A Phase 2 study testing tDCS, tSCS and Cognitive-Motor Task in people with Stroke and Spinal Cord Injury, run by Centre National de la Recherche Scientifique, France at 2 sites in France.
Trial summary
The goal of this clinical study is to investigate the potential synergy between non-invasive brain and spinal cord stimulation administered during a cognitive-motor task, in terms of their immediate effects on sensorimotor and cognitive functions after neurological injuries affecting the upper limb (cervical spinal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spinal Cord Injury, Able Bodied
- What is being tested?
- tDCS, tSCS and Cognitive-Motor Task
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Dec 2024to Dec 2027
- Phase
- Phase 2
- 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
- CONTROL GROUP:
- Over 18 years of age
- Participant who has signed an informed consent form
- Participant who is affiliated with and covered by the social security system
- POST-STROKE GROUP:
- Over 18 years of age
Show all 17Show fewer
- Who sustained a stroke more than 3 weeks ago
- Considered medically stable by the medical investigator
- Who has signed an informed consent form
- Affiliated with and covered by the social security system
- SCI GROUP:
- Over 18 years of age
- Considered to have a complete or incomplete spinal cord injury (i.e., with a score on the Spinal Injury Association (ASIA) Impairment Scale (AIS) score from A to D)
- Considered medically stable by the investigating physician
- Presenting with quadriplegia due to cervical injury
- Who has signed an informed consent form
- Affiliated with and covered by the social security system.
Who cannot join
- Suffering from a chronic condition
- Skin problems or open wounds
- History of epilepsy or seizures
- Presence of a contraindication to the use of magnetic/electrical stimulation or MRI, including: cardiac pacemaker; implanted hearing aid; intraocular foreign body, shrapnel, or bullets; metal worker; pacemaker or neurostimulator; claustrophobia
- Presence of implanted medical devices (cardiac valve, endovascular devices, ventricular shunt valve, surgical clips, metallic sutures, staples, stent, osteosynthesis or arthrodesis hardware) not classified as "MR Conditional" according to ASTM F2503.
- Individuals who are legally incompetent, under judicial protection, guardianship, or trusteeship
- Pregnant and/or breastfeeding women
- Individuals who refuse to be informed of any abnormalities that may be detected by MRI.
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
Service de Médecine Physique & Réadaptation - CHU Bordeaux
Bordeaux, 33000
Hélène Cassoudesalle, MD, PhD, secretariat.mpr@chu-bordeaux.fr
Hélène Cassoudesalle, MD, PhD
- Recruiting
Centre de la Tour de Gassies
Bruges, 33520
Christophe Roth, MD, +33556163191, gassies.contact@ugecam.assurance-maladie.fr
Christophe Roth, MD
About this study
Official title: Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury
The goal of this clinical study is to investigate the potential synergy between non-invasive brain and spinal cord stimulation administered during a cognitive-motor task, in terms of their immediate effects on sensorimotor and cognitive functions after neurological injuries affecting the upper limb (cervical spinal cord injury and stroke). Secondary objectives are to evaluate the relevance of anatomical MRI, functional MRI, and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
Read the detailed description
Over the past decade, innovative electrical stimulation strategies have emerged to improve the effectiveness of conventional rehabilitation approaches following spinal cord injury or stroke. Transcranial direct current stimulation (tDCS) and transcutaneous spinal cord stimulation (tSCS) are two non-invasive stimulation techniques targeting respectively the brain and spinal cord. These techniques have demonstrated immediate and lasting positive effects on the recovery of lost neurological functions following damage to the brain (in the case of stroke) or the spinal cord (in the case of spinal cord injury). Functional improvements leading to a better quality of life have been demonstrated in response to tSCS or tDCS sessions combined with motor training. Recent studies suggest a potential synergistic effect of these two types of intervention, which we propose to characterize in control participants, participants with cervical spinal cord injury, and post-stroke participants.
OBJECTIVES: In this project, we seek to study the potential synergistic effects of an intervention combining non-invasive stimulation of the brain and spinal cord, administered during the performance of a cognitive-motor task, compared to a control intervention and each intervention administered separately, on the recovery of motor and cognitive-motor functions after neurological injury. Secondary objectives are to evaluate the relevance of anatomical MRI data and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
METHODOLOGY/RESEARCH DESIGN: Single-center, prospective, comparative, randomized, crossover, and single-blind clinical study comparing four neuromodulation interventions: S1: tDCS, S2: tSCS, S3: tDCS-tSCS, S4: sham, administered during a cognitive-motor training task of the affected upper limb using the Armeo technology. Three groups of participants will be included: one control group, one group with cervical spinal cord injury, and one post-stroke group. The two groups with either spinal cord injury or stroke will participate in a total of nine visits: the inclusion visit, four testing visits, and four intervention visits. The control group will participate only in the inclusion and testing visits. Outcome measures will include neurophysiological and clinical performance measures.
- Conditions
- Stroke, Spinal Cord Injury, Able Bodied
- Being tested
- tDCS, tSCS, Sham, Cognitive-Motor Task
- Keywords
- Neuromodulation, Neuroplasticity, transcutaneous Spinal Cord Stimulation, transcranial Direct Current Stimulation, Neuroimaging
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSProcedure or surgery
Also called transcranial Direct Current Stimulation
tDCS will be delivered using an electrical stimulation device d (1X1 tES, Soterix Medical Inc., USA, CE marked) delivering a direct current at 2 mA for a period of 20 minutes. Silicone electrodes are placed in sponges soaked in physiological saline (5 cm × 7 cm) (EASYpadTM, Soterix Medical Inc.), with the anode and cathode centered on the optimal cortical areas determined during testing visits.
tSCSProcedure or surgery
Also called transcutaneous Spinal Cord Stimulation
tSCS will be applied for 20 minutes using a constant current electrical stimulator (DS5 or DS7A, Digitimer Ltd, CE marked) delivering monophasic pulses at 30 Hz at stimulation sites and intensities specific to each participant and defined in advance during testing visits.
ShamProcedure or surgery
For the sham stimulation interventions, the current slowly increases to the intensity used during the active interventions for 30 seconds, then slowly decreases over the next 30 seconds, at the beginning and end of the stimulation. The sham interventions use the same electrode placements as during the active ones for a total duration of 20 min.
Cognitive-Motor TaskBehavioural
The cognitive-motor task will be administered using the ArmeoControl software supplied with the ArmeoSping® or ArmeoPower® upper limb rehabilitation exoskeleton. Participants will be seated in a chair or their wheelchair and fitted into the exoskeleton.The exoskeleton is linked to a series of exercises performed on a computer via a virtual reality interface (ArmeoControl), which allows simultaneous training of the arms and hands in a large workspace. Two vertical and horizontal "visually guided reaching" tasks will be offered, each lasting 10 minutes. These tasks are chosen to provide training in cognitive-motor functions (grabbing a target moving in a virtual workspace) and sensorimotor functions (interacting with the exoskeleton to move the target).
| Study group | Role | What they receive |
|---|---|---|
| tDCS+CMT | Experimental | tDCS administered during the performance of cognitive and motor task for 20 min Receives: Procedure: tDCS; Behavioral: Cognitive-Motor Task |
| tSCS+CMT | Experimental | 20-min tSCS administered during the performance of cognitive and motor task for 20 min Receives: Procedure: tSCS; Procedure: Sham |
| tDCS-tSCS+CMT | Active comparator | tDCS associated with tSCS administered during the performance of cognitive and motor task for 20 min Receives: Procedure: tDCS; Procedure: tSCS; Behavioral: Cognitive-Motor Task |
| Sham-tDCS-tSCS+CMT | Sham comparator | Sham tDCS associated with Sham tSCS administered during the performance of cognitive and motor task for 20 min Receives: Procedure: tDCS; Procedure: tSCS; Procedure: Sham; Behavioral: Cognitive-Motor Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Performance
GRASSP subscores: Hand dorsal and palmar sensory function
Measured: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Quantitative Prehension Performance
GRASSP Quantitative Prehension Subscore: Hand prehension motor performance
Measured: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Secondary outcomes (4)
Cognitive performance
Total score on the ECAS multi-domain assessment
Measured: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Safety of the intervention
Safety questionnaire describing side effect appearance and their relative severity. The frequency of a specific side effect will be computed and the severity score (1 to 4) will be averaged across participant
Measured: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Feasibility of the intervention
4-item instrument measuring the feasibility of an intervention. The total score is calculated by summing the four items, yielding a range from 4 to 20, with higher scores indicating greater perceived feasibility of the intervention.
Measured: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Neurophysiological assessment of posterior root-muscle reflexes
Upper-limb electromyographic (EMG) responses during paired-pulse tSCS
Measured: Immediately post-intervention at testing visit #2 (day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start11 Dec 2024
- Primary completion31 Jul 2027 (estimated)
- Study completionDec 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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique, France
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Centre de la Tour de Gassies, Institute of Neurodegenerative Diseases, CNRS UMR 5293
- Responsible party
- Principal investigator, Fabien Wagner, Centre National de la Recherche Scientifique, France
- Investigators
- Fabien Wagner, PhD, Principal investigator, Institute of Neurodegenerative Diseases, CNRS UMR 5293Nabila Brihmat, PhD, Principal investigator, Institute of Neurodegenerative Diseases, CNRS UMR 5293Hélène Cassoudesalle, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334977
- Sponsor's protocol ID
- 2024-A00724-43
- Other IDs
- ARF202309017508
- Acronym
- BrainSpineStim
- Status last verified
- Jan 2026
- First submitted
- 28 Aug 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Based on request and on the data type requested and ethically approved (only non-personally Identifiable Information).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury
- ClinicalTrials.gov ID
- NCT07334977
- Acronym / sponsor ID
- BrainSpineStim / 2024-A00724-43
- Conditions
- Stroke, Spinal Cord Injury, Able Bodied
- Keywords
- Neuromodulation, Neuroplasticity, transcutaneous Spinal Cord Stimulation, transcranial Direct Current Stimulation, Neuroimaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre National de la Recherche Scientifique, FranceUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Centre de la Tour de Gassies, Institute of Neurodegenerative Diseases, CNRS UMR 5293
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jan 2026 (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 goal of this clinical study is to investigate the potential synergy between non-invasive brain and spinal cord stimulation administered during a cognitive-motor task, in terms of their immediate effects on sensorimotor and cognitive functions after neurological injuries affecting the upper limb (cervical spinal cord injury and stroke). Secondary objectives are to evaluate the relevance of anatomical MRI, functional MRI, and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
Detailed description
Over the past decade, innovative electrical stimulation strategies have emerged to improve the effectiveness of conventional rehabilitation approaches following spinal cord injury or stroke. Transcranial direct current stimulation (tDCS) and transcutaneous spinal cord stimulation (tSCS) are two non-invasive stimulation techniques targeting respectively the brain and spinal cord. These techniques have demonstrated immediate and lasting positive effects on the recovery of lost neurological functions following damage to the brain (in the case of stroke) or the spinal cord (in the case of spinal cord injury). Functional improvements leading to a better quality of life have been demonstrated in response to tSCS or tDCS sessions combined with motor training. Recent studies suggest a potential synergistic effect of these two types of intervention, which we propose to characterize in control participants, participants with cervical spinal cord injury, and post-stroke participants.
OBJECTIVES: In this project, we seek to study the potential synergistic effects of an intervention combining non-invasive stimulation of the brain and spinal cord, administered during the performance of a cognitive-motor task, compared to a control intervention and each intervention administered separately, on the recovery of motor and cognitive-motor functions after neurological injury. Secondary objectives are to evaluate the relevance of anatomical MRI data and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
METHODOLOGY/RESEARCH DESIGN: Single-center, prospective, comparative, randomized, crossover, and single-blind clinical study comparing four neuromodulation interventions: S1: tDCS, S2: tSCS, S3: tDCS-tSCS, S4: sham, administered during a cognitive-motor training task of the affected upper limb using the Armeo technology. Three groups of participants will be included: one control group, one group with cervical spinal cord injury, and one post-stroke group. The two groups with either spinal cord injury or stroke will participate in a total of nine visits: the inclusion visit, four testing visits, and four intervention visits. The control group will participate only in the inclusion and testing visits. Outcome measures will include neurophysiological and clinical performance measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS+CMT | Experimental | Procedure: tDCS, Behavioral: Cognitive-Motor TasktDCS administered during the performance of cognitive and motor task for 20 min |
| tSCS+CMT | Experimental | Procedure: tSCS, Procedure: Sham20-min tSCS administered during the performance of cognitive and motor task for 20 min |
| tDCS-tSCS+CMT | Active comparator | Procedure: tDCS, Procedure: tSCS, Behavioral: Cognitive-Motor TasktDCS associated with tSCS administered during the performance of cognitive and motor task for 20 min |
| Sham-tDCS-tSCS+CMT | Sham comparator | Procedure: tDCS, Procedure: tSCS, Procedure: Sham, Behavioral: Cognitive-Motor TaskSham tDCS associated with Sham tSCS administered during the performance of cognitive and motor task for 20 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Over 18 years of age
- Participant who has signed an informed consent form
- Participant who is affiliated with and covered by the social security system
- Over 18 years of age
- Who sustained a stroke more than 3 weeks ago
Key exclusion criteria (8 listed)
- Suffering from a chronic condition
- Skin problems or open wounds
- History of epilepsy or seizures
- Presence of a contraindication to the use of magnetic/electrical stimulation or MRI, including: cardiac pacemaker; implanted hearing aid; intraocular foreign body, shrapnel, or bullets; metal worker; pacemaker or neurostimulator; claustrophobia
- Presence of implanted medical devices (cardiac valve, endovascular devices, ventricular shunt valve, surgical clips, metallic sutures, staples, stent, osteosynthesis or arthrodesis hardware) not classified as "MR Conditional" according to ASTM F2503.
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 |
|---|---|---|
| tDCSAlso: transcranial Direct Current StimulationtDCS will be delivered using an electrical stimulation device d (1X1 tES, Soterix Medical Inc., USA, CE marked) delivering a direct current at 2 mA for a period of 20 minutes. Silicone electrodes are placed in sponges soaked in physiological saline (5 cm × 7 cm) (EASYpadTM, Soterix Medical Inc.), with the anode and cathode centered on the optimal cortical areas determined during testing visits. | Procedure or surgery | Sham-tDCS-tSCS+CMT, tDCS+CMT, tDCS-tSCS+CMT |
| tSCSAlso: transcutaneous Spinal Cord StimulationtSCS will be applied for 20 minutes using a constant current electrical stimulator (DS5 or DS7A, Digitimer Ltd, CE marked) delivering monophasic pulses at 30 Hz at stimulation sites and intensities specific to each participant and defined in advance during testing visits. | Procedure or surgery | Sham-tDCS-tSCS+CMT, tDCS-tSCS+CMT, tSCS+CMT |
| ShamFor the sham stimulation interventions, the current slowly increases to the intensity used during the active interventions for 30 seconds, then slowly decreases over the next 30 seconds, at the beginning and end of the stimulation. The sham interventions use the same electrode placements as during the active ones for a total duration of 20 min. | Procedure or surgery | Sham-tDCS-tSCS+CMT, tSCS+CMT |
| Cognitive-Motor TaskThe cognitive-motor task will be administered using the ArmeoControl software supplied with the ArmeoSping® or ArmeoPower® upper limb rehabilitation exoskeleton. Participants will be seated in a chair or their wheelchair and fitted into the exoskeleton.The exoskeleton is linked to a series of exercises performed on a computer via a virtual reality interface (ArmeoControl), which allows simultaneous training of the arms and hands in a large workspace. Two vertical and horizontal "visually guided reaching" tasks will be offered, each lasting 10 minutes. These tasks are chosen to provide training in cognitive-motor functions (grabbing a target moving in a virtual workspace) and sensorimotor functions (interacting with the exoskeleton to move the target). | Behavioural | Sham-tDCS-tSCS+CMT, tDCS+CMT, tDCS-tSCS+CMT |
Primary outcome
Sensory Performance
Time frame: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
GRASSP subscores: Hand dorsal and palmar sensory function
Quantitative Prehension Performance
Time frame: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
GRASSP Quantitative Prehension Subscore: Hand prehension motor performance
4 secondary outcomes
Cognitive performance
Time frame: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Safety of the intervention
Time frame: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Feasibility of the intervention
Time frame: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Neurophysiological assessment of posterior root-muscle reflexes
Time frame: Immediately post-intervention at testing visit #2 (day 4)
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided. Based on request and on the data type requested and ethically approved (only non-personally Identifiable Information).
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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.
Fabien Wagner, PhD principal investigator
Institute of Neurodegenerative Diseases, CNRS UMR 5293
Nabila Brihmat, PhD principal investigator
Institute of Neurodegenerative Diseases, CNRS UMR 5293
Hélène Cassoudesalle, MD, PhD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tDCS, tSCS and Cognitive-Motor Task in people with Stroke and Spinal Cord Injury, run by Centre National de la Recherche Scientifique, 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 17 inclusion and 8 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 12 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nabila Brihmat, PhD (+33 5 33 51 48 46, nabila.brihmat@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Performance (time frame: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)). The study lists 2 primary outcomes in all. 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 12 Jan 2026.