Recovering arm function in chronic stroke patients using combined anodal HD-tDCS and virtual reality therapy (ReArm): a study protocol for a randomized controlled trial.

After a stroke, 80% of the chronic patients have difficulties to use their paretic upper limb (UL) in activities of daily life (ADL) even after rehabilitation. Virtual reality therapy (VRT) and anodal transcranial direct current stimulation (tDCS) are two innovative methods that have shown independently to positively impact functional recovery of the paretic UL when combined with conventional therapy. The objective of the project will be to evaluate the impact of adding anodal high-definition (HD)-tDCS during an intensive 3-week UL VRT and conventional therapy program on paretic UL function in chronic stroke. The ReArm project is a quadruple-blinded, randomized, sham-controlled, bi-centre, two-arm parallel, and interventional study design. Fifty-eight chronic (> 3 months) stroke patients will be recruited from the Montpellier and Nimes University Hospitals. Patients will follow a standard 3-week in-patient rehabilitation program, which includes 13 days of VRT (Armeo Spring, 1 × 30 min session/day) and conventional therapy (3 × 30 min sessions/day). Twenty-nine patients will receive real stimulation (4x1 anodal HD-tDCS montage, 2 mA, 20 min) to the ipsilesional primary motor cortex during the VRT session and the other 29 patients will receive active sham stimulation (2 mA, 30 s). All outcome measures will be assessed at baseline, at the end of rehabilitation and again 3 months later. The primary outcome measure will be the wolf motor function test. Secondary outcomes will include measures of UL function (Box and Block Test), impairment (Fugl Meyer Upper Extremity), compensation (Proximal Arm Non-Use), ADL (Actimetry, Barthel Index). Other/exploratory outcomes will include pain, fatigue, effort and performance, kinematics, and motor cortical region activation during functional motor tasks. This will be the first trial to determine the impact of adding HD-tDCS during UL VRT and conventional therapy in chronic stroke patients. We hypothesize that improvements in UL function will be greater and longer-lasting with real stimulation than in those receiving sham. The ReArm project was approved by The French Research Ethics Committee, (Comité de Protection des Personnes-CPP SUD-EST II, N°ID-RCB: 2019-A00506-51, http://www.cppsudest2.fr/ ). The ReArm project was registered on ClinicalTrials.gov ( NCT04291573 , 2nd March 2020.

Muller CO ，Muthalib M ，Mottet D ，Perrey S ，Dray G ，Delorme M ，Duflos C ，Froger J ，Xu B ，Faity G ，Pla S ，Jean P ，Laffont I ，Bakhti KKA ... -  《Trials》

Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial.

Levin MF ，Baniña MC ，Frenkel-Toledo S ，Berman S ，Soroker N ，Solomon JM ，Liebermann DG ... -  《Trials》

High-density transcranial direct current stimulation to improve upper limb motor function following stroke: study protocol for a double-blind randomized clinical trial targeting prefrontal and/or cerebellar cognitive contributions to voluntary motion.

Corominas-Teruel X ，Bracco M ，Fibla M ，Segundo RMS ，Villalobos-Llaó M ，Gallea C ，Beranger B ，Toba M ，Valero-Cabré A ，Colomina MT ... -  《Trials》

Effects of the addition of transcranial direct current stimulation to virtual reality therapy after stroke: a pilot randomized controlled trial.

Viana RT ，Laurentino GE ，Souza RJ ，Fonseca JB ，Silva Filho EM ，Dias SN ，Teixeira-Salmela LF ，Monte-Silva KK ... -  《-》

Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.

Lee SH ，Kim WS ，Park J ，Kim J ，Paik NJ ... -  《-》