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Trial record 23 of 45 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

Combining tDCS With VR-based Motor Training in Stroke

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ClinicalTrials.gov Identifier: NCT03144102
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Neuroelectrics Corporation
Information provided by (Responsible Party):
Paul Verschure, Universitat Pompeu Fabra

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.


Condition or disease Intervention/treatment Phase
Virtual Reality Based Therapy Anodal tDCS Occupational Therapy Sham tDCS Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation Device: Anodal transcranial direct-current stimulation (tDCS) Behavioral: Occupational Therapy for upper-limbs motor rehabilitation Device: Sham transcranial direct-current stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Combining Transcranial Direct Current Stimulation (tDCS) With VR-based Motor Training in Hemiparetic Stroke Patients
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : February 8, 2019
Estimated Study Completion Date : May 8, 2019

Arm Intervention/treatment
Experimental: VR-based motor rehabilitation with tDCS Behavioral: 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.

Device: Anodal transcranial direct-current stimulation (tDCS)
Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Active Comparator: Occupational Therapy with tDCS Device: Anodal transcranial direct-current stimulation (tDCS)
Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Behavioral: 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.

Sham Comparator: VR-based motor rehabilitation with sham tDCS Behavioral: 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.

Device: Sham transcranial direct-current stimulation (tDCS)
Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.

Sham Comparator: Occupational Therapy with sham tDCS Behavioral: 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.

Device: Sham transcranial direct-current stimulation (tDCS)
Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Change of Independence as captured by Barthel scale [ Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) ]
  2. 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) ]
  3. Change of interhemispheric balance as captured by EEG recordings [ Time Frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) ]
  4. 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) ]
  5. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144102


Contacts
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Contact: Paul Verschure, Prof. 0034935422202 paul.verschure@upf.edu
Contact: Belén Rubio, PhD 0034935422202 belen.rubio@upf.edu

Locations
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Spain
Unitat de Rehabilitació de l'Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Susana Rodríguez, Dr.         
Sponsors and Collaborators
Universitat Pompeu Fabra
Neuroelectrics Corporation

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Responsible Party: Paul Verschure, Prof., Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT03144102     History of Changes
Other Study ID Numbers: tDCSRGS
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

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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