Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation
NCT ID: NCT07334977
Last Updated: 2026-01-12
Study Results
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Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-12-11
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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tDCS+CMT
tDCS administered during the performance of cognitive and motor task for 20 min
tDCS
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.
Cognitive-Motor Task
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).
tSCS+CMT
20-min tSCS administered during the performance of cognitive and motor task for 20 min
tSCS
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.
Sham
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.
tDCS-tSCS+CMT
tDCS associated with tSCS administered during the performance of cognitive and motor task for 20 min
tDCS
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
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.
Cognitive-Motor Task
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).
Sham-tDCS-tSCS+CMT
Sham tDCS associated with Sham tSCS administered during the performance of cognitive and motor task for 20 min
tDCS
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
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.
Sham
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 Task
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).
Interventions
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tDCS
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
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.
Sham
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 Task
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Who has signed an informed consent form
* Affiliated with and covered by the social security system.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Centre de la Tour de Gassies
UNKNOWN
Institute of Neurodegenerative Diseases, CNRS UMR 5293
UNKNOWN
Centre National de la Recherche Scientifique, France
OTHER
Responsible Party
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Fabien Wagner
Principal investigator
Principal Investigators
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Fabien Wagner, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Neurodegenerative Diseases, CNRS UMR 5293
Nabila Brihmat, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Neurodegenerative Diseases, CNRS UMR 5293
Hélène Cassoudesalle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Service de Médecine Physique & Réadaptation - CHU Bordeaux
Bordeaux, , France
Centre de la Tour de Gassies
Bruges, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ARF202309017508
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-A00724-43
Identifier Type: -
Identifier Source: org_study_id
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