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

Abstract

Background 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. Methods 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. Discussion 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. Trial registration 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.

The effect of sequential combination of mirror therapy and robot-assisted therapy on motor function, daily function, and self-efficacy after stroke

“…Based on the timeline of stroke recovery framework proposed by SRRR group, chronic stroke is defined as 6 months after stroke onset and 3 to 6 months post-stroke refers to as late sub-acute phase 46 . In stroke rehabilitation studies, several researchers used chronic stroke to describe patients who were at least 3 months after stroke 47 , 48 and we adopted the broad definition of chronic stroke in this study. Our findings indicated that chronic stroke survivors seem to benefit from robot-assisted therapy in upper limb function and functional independence.…”

Comparison of wrist actimetry variables of paretic upper limb use in post stroke patients for ecological monitoring

“…In view of the greater sensitivity of the FuncUseRatio to Fugl-Meyer scores, it would be appropriate to use this variable in the longitudinal assessment of patients undergoing therapies programs. We are thinking in particular of therapies based on virtual reality tools and transcranial stimulation [ 24 ]. Like the FuncUseRatio30 developed by Leuenberger et al [ 12 ] correlates linearly with the BBT, we showed that the FuncUseRatio30, the UseHoursRatio and the JR50 correlate linearly with the Fugl Meyer score.…”

Effect of tDCS Concurrent With VR-based Robot on Hemiplegic Upper Limb Function After Ischemic Stroke: A Randomized Controlled Study

“…Studies have used anodal tDCS to stimulate the iM1 to boost M1 excitability and promote neuroplasticity, thereby contributing to the recovery of upper limb function [7,11]. Jamil et al studied the in uence of tDCS on cerebral blood ow through fMRI, and found that tDCS not only stimulated M1, but also other areas such as the premotor and somatosensory cortex, and speculated that tDCS might affect the excitability of interconnected brain networks and cerebral blood ow activities [48].…”

“…Transcranial direct current stimulation (tDCS) is a potential NIBS method which regulates cortical excitability through the application of low levels of current to the scalp [7]. Anodal and cathodal tDCS can upregulate and inhibit cortical excitability, respectively [8].…”