Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention (REACT01)

Hospitales Nisa

Status: Completed

Conditions: Stroke; Upper Limb Injury; Hemiparesis; Chronic Stroke

Treatments: Device: REACt system; Other: Physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03528018

TIN2014-61975-EXP (Other Grant/Funding Number)

BES-2014-068218 (Other Grant/Funding Number)

NISA-PHYS-2016/1

Details and patient eligibility

About

Rehabilitation options for stroke survivors who present severe hemiparesis in chronic stages are limited and may end in compensation techniques that involve the use of the less affected arm to achieve some degree of functional independence. Transcranial direct current stimulation (tDCS) is a non-invasive technique that has been used after stroke to promote excitability of the surviving neural architecture in order to support functional recovery. Interestingly, cortical excitability has been reported to increase when tDCS is combined with virtual reality. This synergetic effect could explain the promising results achieved by preliminary experimental interventions that combined both approaches on upper limb rehabilitation after stroke. The objective of this study is to explore the use of these interventions in subjects with severe hemiparesis and to determine its efficacy in comparison to conventional physical therapy

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronicity > six months
• severe paresis of the upper limb defined by the Brunnstrom Approach as stages I or II and by the Upper Extremity subscale of the Fugl-Meyer Assessment as scores below 19
• ability to maintain a sitting position for at least 60 minutes
• fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23.

Exclusion criteria

• pacemakers
• brain implants or other metallic objects (valves, coils, etc.)
• impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45
• severe visual impairments
• emotional or behavioral circumstances that impede adequate collaboration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

14 participants in 2 patient groups

Control

Other group

Description:

Conventional physical therapy

Treatment:

Other: Physical therapy

Experimental

Experimental group

Description:

Combined tDCS and VR-based intervention

Treatment:

Other: Physical therapy

Device: REACt system