- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03144102
Combining tDCS With VR-based Motor Training in Stroke
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
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul Verschure, Prof.
- Phone Number: 0034935422202
- Email: paul.verschure@upf.edu
Study Contact Backup
- Name: Belén Rubio, PhD
- Phone Number: 0034935422202
- Email: belen.rubio@upf.edu
Study Locations
-
-
-
Barcelona, Spain, 08035
- Recruiting
- Unitat de Rehabilitació de l'Hospital Vall d'Hebron
-
Contact:
- Susana Rodríguez, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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