Combining tDCS With VR-based Motor Training in Stroke

August 7, 2020 updated by: Paul Verschure, Universitat Pompeu Fabra

The Effects of Combining Transcranial Direct Current Stimulation (tDCS) With VR-based Motor Training in Hemiparetic Stroke Patients

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Barcelona, Spain, 08035
        • Recruiting
        • Unitat de Rehabilitació de l'Hospital Vall d'Hebron
        • Contact:
          • Susana Rodríguez, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR-based motor rehabilitation with tDCS
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.
Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.
Active Comparator: Occupational Therapy with tDCS
Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.
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 Comparator: VR-based motor rehabilitation with sham tDCS
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.
Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.
Sham Comparator: Occupational Therapy with sham tDCS
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.
Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of arm/hand function as captured by the upper extremity Fugl-Meyer assessment scale
Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Independence as captured by Barthel scale
Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of motor function in ADLs as captured by Chedoke Arm and Hand Activity Inventory (CAHAI) scale
Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of interhemispheric balance as captured by EEG recordings
Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of spasticity in proximal and distal muscles as captured by Ashworth scale
Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of spatial hemineglect as captured by the Star cancellation test
Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Anticipated)

December 8, 2020

Study Completion (Anticipated)

June 8, 2021

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • tDCSRGS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Occupational Therapy

Clinical Trials on Virtual Reality-based therapy for upper-limbs motor rehabilitation

3
Subscribe