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Interactive Motor Imagery in Virtual Reality

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ClinicalTrials.gov Identifier: NCT02149186
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This project will build and test the first rehabilitation system employing virtual reality (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and motor dysfunction in participants with an incomplete spinal cord injury or another neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for legs). Patients using the system will control virtual representations of their legs to engage in entertaining gaming interactions.

Condition or disease Intervention/treatment
Spinal Cord Injury Stroke Device: iCTuS-L

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : October 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rehabilitation Device: iCTuS-L


Outcome Measures

Primary Outcome Measures :
  1. Sensorimotor Assessment [ Time Frame: 16 weeks ]
    Questionnaire assessing distinct pain qualities associated with neuropathic pain, structured pain interview, questionnaire for assessing patients diagnosed as depressed and detects depression among the normal population, transcutaneous electrical stimulation of superficial nerves, information about the motor level of the lesion, the sensory levels of the lesion (light touch and pin prick), questionnaire assessing activities of daily life and independence in subjects with spinal cord lesion, walking aids and/or personal assistance, examining gait speed, transcranial magnetic stimulation


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 16 and 80
  • clinically incomplete spinal cord injury (time since injury: chronic > 1 year; acute < 3 months)
  • ASI C or D
  • neuropathic pain and/or motor deficits
  • diagnosed neurological disorder, eg. stroke

Exclusion Criteria:

  • any disease limiting training
  • epilepsy
  • major depression or psychosis
Contacts and Locations

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): NCT02149186


Contacts
Contact: Michael Villiger, PhD michael.villiger@supsi.ch

Locations
Switzerland
Curt, Armin, MD Recruiting
Zurich, Switzerland, 8008
Contact: Armin Curt, Prof., MD    +41 44 386 39 01    armin.curt@balgrist.ch   
Sponsors and Collaborators
University of Zurich
More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02149186     History of Changes
Other Study ID Numbers: EK-24 2009/PB_2016-00545
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries