Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05877560
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2023-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Near Point of Convergence (NPC)', 'timeFrame': '4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment', 'description': 'A change in the NPC break and recovery values measured in centimeters (cm) from baseline after treatment.'}, {'measure': 'Positive Fusional Vergence (PFV)', 'timeFrame': '4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment', 'description': 'A change in the near PFV blur, break, and recovery values measured in prism diopters (∆) from baseline after treatment.'}], 'secondaryOutcomes': [{'measure': 'Convergence Insufficiency Symptoms Survey (CISS)', 'timeFrame': '8 weeks during treatment; 6 months and 12 months post-treatment', 'description': 'A change in the CISS score from baseline after treatment. The minimum score is 0 and the maximum score is 60. Lower scores indicate a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Convergence Insufficiency', 'Non-invasive Brain Stimulation', 'Office-Based Vergence/Accommodative Therapy', 'Frontal Eye Fields', 'Transcranial Direct Current Stimulation'], 'conditions': ['Convergence Insufficiency']}, 'referencesModule': {'references': [{'pmid': '8092638', 'type': 'BACKGROUND', 'citation': 'Duval JL, Jaubert D, Poizot-Martin I, De Jaureguiberry JP, Lafeuillade A, Giovannini M, Carloz E, Dhiver C, Gastaut JA. [Colonic leishmaniasis in AIDS]. Ann Med Interne (Paris). 1994;145(3):198-9. No abstract available. French.'}, {'pmid': '7744390', 'type': 'BACKGROUND', 'citation': 'Xie Y, Wan B, Li W. [Effect of bee pollen on maternal nutrition and fetal growth]. Hua Xi Yi Ke Da Xue Xue Bao. 1994 Dec;25(4):434-7. Chinese.'}, {'pmid': '2779032', 'type': 'BACKGROUND', 'citation': 'Nakano H, Ida T, Harada A, Horiba K, Sakakibara T, Kawase M, Tatsuno K, Obunai Y, Murata M. [Application of epicardial approach technique to the anterior-paraseptal type Wolff-Parkinson-White syndrome]. Kyobu Geka. 1989 May;42(5):358-62. Japanese.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to test the effectiveness of non-invasive brain stimulation in treating adults with symptomatic convergence insufficiency compared to vergence/accommodative therapy. The main questions it aims to answer are:\n\n1. Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency?\n2. Is non-invasive brain stimulation alone just as effective as office-based vergence/accommodative therapy in treating convergence insufficiency?\n\nThe investigators hypothesize that non-invasive brain stimulation will shorten the treatment time from 12 weeks to 8 weeks of office-based vergence/accommodative therapy and that non-invasive brain stimulation alone would be equally effective as office-based vergence/accommodative therapy in improving symptomatic convergence insufficiency.\n\nParticipants will be randomized into one of three treatment groups:\n\n1. Non-invasive brain stimulation with office-based vergence/accommodative therapy.\n2. Sham stimulation with office-based vergence/accommodative therapy.\n3. Non-invasive brain stimulation only.\n\nResearchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Best-corrected visual acuity of \\> 20/25 in each eye at distance and near\n* Exophoria at near at least 4∆ greater than at far\n* Receded near point of convergence of \\> 6 cm break\n* Insufficient positive fusional vergence at near (\\< 15∆ base-out blur or break)\n* CISS score of 16 and greater for children or 21 and greater for adults\n* Have had a dilated fundus examination within the last 12 months\n* Informed consent and willingness to participate in the study and be randomized\n\nExclusion Criteria:\n\n* Previously treated for convergence insufficiency with home- or office-based vergence/accommodative therapy\n* Amblyopia (\\> 2-line difference in best-corrected visual acuity between the two eyes)\n* Constant strabismus\n* History of strabismus surgery\n* Convergence insufficiency secondary to acquired brain injury or neurological disorder\n* Manifest or latent nystagmus\n* Systemic disease known to affect accommodation, vergence, and ocular motility including multiple sclerosis, Graves disease, myasthenia gravis, Parkinson's disease, cerebral palsy, and diabetes\n* Developmental disability, attention deficit hyperactivity disorder (ADHD), learning disability or cognitive dysfunction that would interfere with treatment\n* Taking medications that can affect normal neurological function including antipsychotics, antiepileptics, and opioids\n* Presence of metal or electronic implants in or on the body, including pacemakers"}, 'identificationModule': {'nctId': 'NCT05877560', 'acronym': 'NIBSCI', 'briefTitle': 'Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Midwestern University'}, 'officialTitle': 'A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency', 'orgStudyIdInfo': {'id': 'CIRB-IL 22013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NIBS-OBVAT', 'description': '8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.', 'interventionNames': ['Device: Anodal-Transcranial Direct Current Stimulation', 'Behavioral: Office-Based Vergence/Accommodative Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NIBS', 'description': '8 sessions of non-invasive brain stimulation only.', 'interventionNames': ['Device: Anodal-Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'OBVAT', 'description': '8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.', 'interventionNames': ['Behavioral: Office-Based Vergence/Accommodative Therapy', 'Device: Sham Transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Anodal-Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS', 'a-tDCS'], 'description': 'Non-invasive brain stimulation will involve the use of anodal transcranial direct current stimulation to apply a 2 milliamp current over the left frontal eye field for approximately 20 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds.', 'armGroupLabels': ['NIBS', 'NIBS-OBVAT']}, {'name': 'Office-Based Vergence/Accommodative Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['OBVAT', 'Orthoptic training'], 'description': 'Office-based vergence accommodative therapy involves weekly in-office appointments with the therapist lasting approximately 60 minutes per visit during which time in-office procedures will be performed, and home therapy procedures will be demonstrated. Participants will be prescribed 15 minutes of home reinforcement therapy procedures to be completed 5 days per week. Therapy will consist of two phases adapted from the Convergence Insufficiency Treatment Trial (CITT). Therapy procedures will include gross convergence, accommodation. non-computer based vergence, and computer-based vergence.', 'armGroupLabels': ['NIBS-OBVAT', 'OBVAT']}, {'name': 'Sham Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['Sham tDCS'], 'description': 'Sham transcranial direct current stimulation will be applied over the left frontal eye field with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 20 minutes.', 'armGroupLabels': ['OBVAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherri Olsen', 'role': 'CONTACT', 'email': 'solsen@midwestern.edu', 'phone': '1-630-515-7368'}, {'name': 'Arijit Chakraborty, PhD', 'role': 'CONTACT'}, {'name': 'Adrienne C Quan, OD', 'role': 'CONTACT'}, {'name': 'Clinton R Prestwich, OD', 'role': 'CONTACT'}], 'facility': 'Midwestern University Eye Institute', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}], 'centralContacts': [{'name': 'Arijit Chakraborty, PhD', 'role': 'CONTACT', 'email': 'achakr@midwestern.edu', 'phone': '630-960-3172'}, {'name': 'Adrienne C Quan, OD', 'role': 'CONTACT', 'email': 'aquan@midwestern.edu', 'phone': '630-960-3183'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Director of Research', 'investigatorFullName': 'Arijit Chakraborty', 'investigatorAffiliation': 'Midwestern University'}}}}