Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre National de la Recherche Scientifique, France
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
tDCS
Procedure/SurgerytDCS 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
Procedure/SurgerytSCS 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
Procedure/SurgeryFor 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
BehavioralThe 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).
Treatment groups
45 Participants
are divided into 4 treatment groupsGroup A: tDCS+CMTExperimental treatment 2 interventions
Group B: tSCS+CMTExperimental treatment 2 interventions
Group C: tDCS-tSCS+CMTActive comparator 3 interventions
Group D: Sham-tDCS-tSCS+CMTSham comparator 4 interventions
Trial outcomes
Primary outcomes
1
Sensory Performance
GRASSP subscores: Hand dorsal and palmar sensory function
Time frame
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)2
Quantitative Prehension Performance
GRASSP Quantitative Prehension Subscore: Hand prehension motor performance
Time frame
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)Secondary outcomes
1
Cognitive performance
Total score on the ECAS multi-domain assessment
Time frame
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)2
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
Time frame
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)3
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.
Time frame
Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)4
Neurophysiological assessment of posterior root-muscle reflexes
Upper-limb electromyographic (EMG) responses during paired-pulse tSCS
Time frame
Immediately post-intervention at testing visit #2 (day 4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre National de la Recherche Scientifique, France
Lead sponsor
University Hospital, Bordeaux
Collaborator
Centre de la Tour de Gassies
Collaborator
Institute of Neurodegenerative Diseases, CNRS UMR 5293
Collaborator
Source ClinicalTrials.gov