Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation

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.

Conditions

• Stroke
• Spinal Cord Injury
• Able Bodied

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

BEHAVIORAL

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).

Sponsors & Collaborators

• University Hospital, Bordeaux

  collaborator OTHER

• Centre de la Tour de Gassies

  collaborator UNKNOWN

• Institute of Neurodegenerative Diseases, CNRS UMR 5293

  collaborator UNKNOWN

• Centre National de la Recherche Scientifique, France

  lead OTHER

Principal Investigators

• Fabien Wagner, PhD · Institute of Neurodegenerative Diseases, CNRS UMR 5293

• Nabila Brihmat, PhD · Institute of Neurodegenerative Diseases, CNRS UMR 5293

• Hélène Cassoudesalle, MD, PhD · University Hospital, Bordeaux

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-11

Primary Completion

2027-07-31

Completion

2027-12-31

Countries

• France

Study Locations