Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT02678494
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain-Train Home Based Pain Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in intensity of pain as measured by the Visual Numerical Scale'}], 'secondaryOutcomes': [{'measure': 'Brain activity', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in brain activity as measured by EEG'}, {'measure': "Patients' perspective of home-based neuro-therapy training", 'timeFrame': '3 months', 'description': "Qualitative assessment of patient's perspective of treatment as assessed by questionnaire and one-to-one semi-structured interview"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injury'], 'conditions': ['Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'A study examining the effectiveness of neurofeedback therapy for the treatment of Central Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly device which can be operated by patients at home.', 'detailedDescription': "Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation from the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury.\n\nIn 30% to 40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.\n\nIn a previous study, some characteristic 'signatures' of brain waves that are related to CNP were defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Costly laboratory devices were used and once the study was over, an adequate alternative could not be offered to patients.\n\nIn this study, a cheap, portable, wireless and user friendly, Conformité Européenne (CE) marked EEG device will be used to train 10 patients to self-administer the therapy in the comfort of their homes. Participants will be given initial training to use the equipment then will be asked to use the system at home for 3 months - initially, 3-5 times a week then, if/when pain subsides, at least once a week or as required.\n\nThe primary purpose of the study is to determine whether a portable system for neuromodulation is a useful tool for administering therapy for pain (intensity of pain will be measured by the visual numerical scale (VNS)).\n\nThe secondary purpose of the study is a quantitative analysis of changes in the brain activity due to therapy, as measured by EEG; patients' perspective of the home based neuro-therapy (assessed by questionnaires and one-to-one, semi-structured interviews)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal or corrected to normal vision\n* no history of brain disease or injury\n* incomplete/complete injury at level C5 to T12\n* central neuropathic pain (below the level of injury)\n* intensity of pain 4 or above (VNS)\n* stable medication regime (expected not to change during the period of the study), responding to some extent to CNP medication treatment\n* patient or caregiver minimum computer literacy (owning a computer, laptop, tablet, ipad etc)\n\nExclusion Criteria:\n\n* chronic or acute muscular or visceral pain larger than 4 VNS\n* epilepsy\n* diagnosed mental health problems\n* active intervention of pain team (changing existing treatments)'}, 'identificationModule': {'nctId': 'NCT02678494', 'briefTitle': 'Brain-Train Home Based Pain Treatment', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Home Based Brain-Train Treatment of Central Neuropathic Pain Following Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'GN15NE124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback training', 'description': 'Neurofeedback training: self-administered at home for 3 months. 3-5 sessions per week initially, then at least once a week. Each session consists of 5-6 blocks of 5 minute training.', 'interventionNames': ['Other: Neurofeedback training']}], 'interventions': [{'name': 'Neurofeedback training', 'type': 'OTHER', 'armGroupLabels': ['Neurofeedback training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth National Spinal Injuries Unit', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Aleksandra Vuckovic, Dipl Ing MSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}