Combining tDCS With VR-based Motor Training in Stroke

NCT ID: NCT03144102

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2021-06-08

Brief Summary

Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. There is a need to deploy new approaches that advance the current rehabilitation methods and enhance their efficiency.

One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices. On the other hand, recent studies have shown the potential of transcranial direct current stimulation (tDCS) to restore motor function in hemiparetic stroke patients. It must be emphasized, however, that so far little work exists on the quantitative assessment of the clinical impact of VR based approaches in combination with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational therapy with tDCS, and 3) occupational therapy without tDCS.

The findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.

Conditions

Virtual Reality Based Therapy; Anodal tDCS; Occupational Therapy; Sham tDCS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VR-based motor rehabilitation with tDCS

Group Type: EXPERIMENTAL

Virtual Reality-based therapy for upper-limbs motor rehabilitation

Intervention Type: BEHAVIORAL

During each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session.

Anodal transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Occupational Therapy with tDCS

Group Type: ACTIVE_COMPARATOR

Anodal transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Occupational Therapy for upper-limbs motor rehabilitation

Intervention Type: BEHAVIORAL

During each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session.

VR-based motor rehabilitation with sham tDCS

Group Type: SHAM_COMPARATOR

Virtual Reality-based therapy for upper-limbs motor rehabilitation

Intervention Type: BEHAVIORAL

During each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session.

Sham transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Occupational Therapy with sham tDCS

Group Type: SHAM_COMPARATOR

Occupational Therapy for upper-limbs motor rehabilitation

Intervention Type: BEHAVIORAL

During each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session.

Sham transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Interventions

Virtual Reality-based therapy for upper-limbs motor rehabilitation

During each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session.

Intervention Type: BEHAVIORAL

Anodal transcranial direct-current stimulation (tDCS)

Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Intervention Type: DEVICE

Occupational Therapy for upper-limbs motor rehabilitation

During each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session.

Intervention Type: BEHAVIORAL

Sham transcranial direct-current stimulation (tDCS)

Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with hemiparesis secondary to first ever ischemic or hemorrhagic stroke (Medical Research Council score > 2).
• Older than 18 years old.
• Sufficient cognitive capacity to understand and follow the experimental instructions (Mini-Mental State Evaluation > 20).

Exclusion Criteria

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Epilepsia and metal implants. A diagnostic EEG will be performed by the Department of Clinical Neurophysiology of the hospital to detect epileptic paroxysmal in order to include or exclude patients in the study.
• Low Cognitive capabilities that prohibits the execution of the experiment Arteriovenous malformation
• Severe associated impairment such as spasticity, communication disabilities (sensorial, mixed or global aphasia or apraxia), major pain or other neuromuscular impairments or orthopaedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale > 3)
• History of serious mental-health problems in acute or sub acute phase
• Refusal to sign the consent form
• Previous surgeries opening the skull.
• Active or recent substance abuse or dependence within the past year.
• Pregnancy, breastfeeding, unwillingness to practice birth control during participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuroelectrics Corporation

INDUSTRY

Sponsor Role: collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role: lead

Responsible Party

Paul Verschure

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Unitat de Rehabilitació de l'Hospital Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Paul Verschure, Prof.

Role: CONTACT

paul.verschure@upf.edu

0034935422202

Belén Rubio, PhD

Role: CONTACT

belen.rubio@upf.edu

0034935422202

Facility Contacts

Susana Rodríguez, Dr.

Role: primary

Other Identifiers

tDCSRGS

Identifier Type: -

Identifier Source: org_study_id