Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-22 @ 12:00 PM
Study NCT ID:
NCT01943656
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2013-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eyegaze Systems for Spinal Cord Injury: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire', 'timeFrame': '8 weeks', 'description': 'Change in score between 0 and 8 weeks.'}], 'primaryOutcomes': [{'measure': 'Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire', 'timeFrame': '8 weeks', 'description': 'Change in score between 0 and 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '8 weeks', 'description': 'Change in score between 0 and 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injury'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.smsf.org.uk/research%20projects.htm', 'label': 'Website directing to project description and updates'}]}, 'descriptionModule': {'briefSummary': "As technologies are advancing quickly in the healthcare setting, new solutions have become available helping disable people to enhance their ability to communicate. One of these advances is the introduction of the 'eye gaze system'. Through processing eye movements, this device allows a person to write, speak, use the Internet and even control systems in the home or office. In the currently proposed study we aim to evaluate the psychological and functional effects of using the Tobii™ Eyegaze System by inpatients with tetraplegia who are unable to use arms and legs and sometimes are not able to talk because of an impaired respiratory function.\n\nVolunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™ Eyegaze System by inpatients with tetraplegia results in improved disability perception and independence scores. For the current feasibility study 12 participants will be recruited and assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and 'eyeskills' to instruct the computer system. Positive study outcomes will encourage future studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home environment.", 'detailedDescription': "Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™ Eyegaze System by inpatients with tetraplegia results in improved disability perception and independence scores. For the current feasibility study 12 participants will be recruited and assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and 'eyeskills' to instruct the computer system. Positive study outcomes will encourage future studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home environment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal Cord Injury at C7 level or above\n* American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C or D\n* Age equal or higher than 16 years old\n* Expected to stay least 10 weeks at the National Spinal Injuries Centre\n\nExclusion Criteria:\n\n* History of severe neurological injuries other than Spinal Cord Injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)\n* Planned discharge within 10 weeks time\n* Psychiatric or cognitive conditions that may interfere with the study\n* Patients incapable of providing informed consent'}, 'identificationModule': {'nctId': 'NCT01943656', 'briefTitle': 'Eyegaze Systems for Spinal Cord Injury: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Buckinghamshire Healthcare NHS Trust'}, 'officialTitle': 'A Longitudinal Clinical Feasibility Study to Evaluate the Psychological and Functional Effects of Using the Tobii™ Eyegaze System by Inpatients With Tetraplegia', 'orgStudyIdInfo': {'id': '13/EE/0049 (UK NRES)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobii™ Eyegaze System', 'description': 'Single arm, open label study.', 'interventionNames': ['Device: Tobii™ Eyegaze System']}], 'interventions': [{'name': 'Tobii™ Eyegaze System', 'type': 'DEVICE', 'otherNames': ['Eyegaze System, Eye-tracking Operation System'], 'description': 'Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months.', 'armGroupLabels': ['Tobii™ Eyegaze System']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HP21 8AL', 'city': 'Aylesbury', 'state': 'Buckinghamshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'CONTACT', 'email': 'Joost.vanMiddendorp@buckshealthcare.nhs.uk', 'phone': '+44 1296316783'}, {'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'F Watkins, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'H Landymore, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'C Park, BSc, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Spinal Injuries Centre, Stoke Mandeville Hospital', 'geoPoint': {'lat': 51.81665, 'lon': -0.81458}}], 'centralContacts': [{'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'CONTACT', 'email': 'Joost.vanMiddendorp@buckshealthcare.nhs.uk', 'phone': '+44 1296316783'}], 'overallOfficials': [{'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stoke Mandeville Spinal Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buckinghamshire Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}