Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation
BrainSpineStim
Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury
2 other identifiers
interventional
45
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 stroke
Started Dec 2024
Typical duration for phase_2 stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2024
CompletedFirst Submitted
Initial submission to the registry
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
January 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 12, 2026
January 1, 2026
2.6 years
August 28, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensory Performance
GRASSP subscores: Hand dorsal and palmar sensory function
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
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Secondary Outcomes (4)
Cognitive performance
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Safety of the intervention
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Feasibility of the intervention
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
Neurophysiological assessment of posterior root-muscle reflexes
Immediately post-intervention at testing visit #2 (day 4)
Study Arms (4)
tDCS+CMT
EXPERIMENTALtDCS administered during the performance of cognitive and motor task for 20 min
tSCS+CMT
EXPERIMENTAL20-min tSCS administered during the performance of cognitive and motor task for 20 min
tDCS-tSCS+CMT
ACTIVE COMPARATORtDCS associated with tSCS administered during the performance of cognitive and motor task for 20 min
Sham-tDCS-tSCS+CMT
SHAM COMPARATORSham tDCS associated with Sham tSCS administered during the performance of cognitive and motor task for 20 min
Interventions
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.
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
- 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
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de Médecine Physique & Réadaptation - CHU Bordeaux
Bordeaux, 33000, France
Centre de la Tour de Gassies
Bruges, 33520, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabien Wagner, PhD
Institute of Neurodegenerative Diseases, CNRS UMR 5293
- PRINCIPAL INVESTIGATOR
Nabila Brihmat, PhD
Institute of Neurodegenerative Diseases, CNRS UMR 5293
- PRINCIPAL INVESTIGATOR
Hélène Cassoudesalle, MD, PhD
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 28, 2025
First Posted
January 12, 2026
Study Start
December 11, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 12, 2026
Record last verified: 2026-01