RecruitingPhase 2NCT07334977

Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation

Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury

Sponsor

Centre National de la Recherche Scientifique, France

Enrollment

45 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke Spinal Cord Injury Able Bodied

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria17

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
Who has signed an informed consent form
Affiliated with and covered by the social security system.

Exclusion Criteria8

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.

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Interventions

PROCEDUREtDCS

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.

PROCEDUREtSCS

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.

PROCEDURESham

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.

BEHAVIORALCognitive-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).