Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01028456
Status:
UNKNOWN
Last Update Posted:
2009-12-09
First Post:
2009-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of Light Therapy for Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-08', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of seizures/month', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Mood', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Seizures', 'Light Therapy'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '23520221', 'type': 'DERIVED', 'citation': "Baxendale S, O'Sullivan J, Heaney D. Bright light therapy for symptoms of anxiety and depression in focal epilepsy: randomised controlled trial. Br J Psychiatry. 2013 May;202(5):352-6. doi: 10.1192/bjp.bp.112.122119. Epub 2013 Mar 21."}, {'pmid': '22658437', 'type': 'DERIVED', 'citation': "Baxendale S, O'Sullivan J, Heaney D. Bright light therapy as an add on treatment for medically intractable epilepsy. Epilepsy Behav. 2012 Jul;24(3):359-64. doi: 10.1016/j.yebeh.2012.04.123. Epub 2012 May 30."}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate whether light therapy may be an effective treatment for some people with epilepsy. Light treatment is already an established treatment for depression. The chemical systems in the brain that are disrupted when someone becomes depressed, overlap with some of those that can be affected during some epileptic seizures. The investigators have designed this study to see whether light therapy may also lead to a decrease in seizures in people who have epilepsy.\n\nThe study will be a placebo controlled trial. This means that half of the participants will receive a therapeutic dose of light therapy from a light box, whilst the other half will only receive a placebo light treatment.', 'detailedDescription': 'The aim of this study is to investigate a new, non invasive treatment for epilepsy that may be useful as an adjunctive therapy for people whose seizures are poorly controlled with anti epileptic drugs. Light therapy is a well established treatment for some forms of depression. From the cellular level to epidemiological studies, there are numerous strands of evidence in the scientific literature that indicate that light therapy could be also an effective treatment for some people with epilepsy.\n\nThe proposed study is a randomised placebo controlled trial of light therapy. One hundred people with medically refractory epilepsy will be recruited. Participants will be randomised to receive either therapeutic or placebo doses of light therapy from an identical device for 30 minutes a day during the treatment phase of the study. The statistical power of this study design is \\>90% to detect a 25% reduction in seizure frequency during the treatment phase. Although this therapeutic approach is more likely to be palliative than curative, it represents a non invasive and relatively inexpensive add-on treatment option for a sub group of patients who may have reached the end of the road in other medical and surgical treatment options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Medically intractable epilepsy\n* Min 4 complex partial seizures/ month\n\nExclusion Criteria:\n\n* Ability to give informed consent\n* Underlying progressive neurological condition'}, 'identificationModule': {'nctId': 'NCT01028456', 'briefTitle': 'Clinical Trial of Light Therapy for Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.', 'orgStudyIdInfo': {'id': '09 H0716 68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '100 lux', 'description': '100 lux / 30 minutes day', 'interventionNames': ['Other: 100 lux']}, {'type': 'EXPERIMENTAL', 'label': 'Light Therapy 10,000 lux', 'description': '10,000 lux / 30 minutes a day for 3 months', 'interventionNames': ['Other: Light Therapy']}], 'interventions': [{'name': 'Light Therapy', 'type': 'OTHER', 'otherNames': ['Diamond 4 light box'], 'description': '10,000 lux / 30 minutes a day', 'armGroupLabels': ['Light Therapy 10,000 lux']}, {'name': '100 lux', 'type': 'OTHER', 'description': 'Placebo light', 'armGroupLabels': ['100 lux']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 3BG', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'National Hospital for Neurology & Neurosurgery', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Action Medical Research', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mr Philip Diamond Senior Research Administrator', 'oldOrganization': 'UCL'}}}}