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Trial record 23 of 44 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

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE May 15, 2017
Estimated Primary Completion Date February 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03144102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
  • Change of Independence as captured by Barthel scale [ Time Frame: 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) ]
  • Change of interhemispheric balance as captured by EEG recordings [ Time Frame: 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining tDCS With VR-based Motor Training in Stroke
Official Title  ICMJE The Effects of Combining Transcranial Direct Current Stimulation (tDCS) With VR-based Motor Training in Hemiparetic Stroke Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Virtual Reality Based Therapy
  • Anodal tDCS
  • Occupational Therapy
  • Sham tDCS
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: VR-based motor rehabilitation with tDCS
    Interventions:
    • Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation
    • Device: Anodal transcranial direct-current stimulation (tDCS)
  • Active Comparator: Occupational Therapy with tDCS
    Interventions:
    • Device: Anodal transcranial direct-current stimulation (tDCS)
    • Behavioral: Occupational Therapy for upper-limbs motor rehabilitation
  • Sham Comparator: VR-based motor rehabilitation with sham tDCS
    Interventions:
    • Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation
    • Device: Sham transcranial direct-current stimulation (tDCS)
  • Sham Comparator: Occupational Therapy with sham tDCS
    Interventions:
    • Behavioral: Occupational Therapy for upper-limbs motor rehabilitation
    • Device: Sham transcranial direct-current stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 8, 2019
Estimated Primary Completion Date February 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul Verschure, Prof. 0034935422202 paul.verschure@upf.edu
Contact: Belén Rubio, PhD 0034935422202 belen.rubio@upf.edu
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03144102
Other Study ID Numbers  ICMJE tDCSRGS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Verschure, Universitat Pompeu Fabra
Study Sponsor  ICMJE Universitat Pompeu Fabra
Collaborators  ICMJE Neuroelectrics Corporation
Investigators  ICMJE Not Provided
PRS Account Universitat Pompeu Fabra
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP