Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:21 AM
Study NCT ID:
NCT07369960
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}, {'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, their guardians, the language therapists providing individualized training, and the outcome assessors conducting language evaluations will all be blinded to group allocation. Outcome assessors will have no involvement in the randomization or intervention processes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules', 'timeFrame': 'Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).', 'description': "The language subscale of the Gesell Developmental Schedules is used to evaluate a child's language development. The result is expressed as a Developmental Quotient (DQ), a continuous score where 100 represents performance at the exact chronological age level. A higher DQ indicates better language abilities."}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Language Developmental Stage via Sign-Significate Relations (S-S) Assessment', 'timeFrame': 'Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).', 'description': 'The S-S method is a standardized tool for the detailed diagnosis and classification of language developmental delay in children. It assesses both language comprehension and expression abilities, assigning the child to a specific developmental stage.The core outcome is the assigned Stage (I to V, with subdivisions). Higher stages indicate more advanced language development. For analysis, stages are often converted to an ordinal numerical score (e.g., Stage I=1, Stage II=2, etc.). The minimum score is 1 (lowest stage), and the maximum is 5 (highest stage).'}, {'measure': 'Number of Participants with the Systematic Assessment for Treatment of Emergent Events (SAFTEE) [Safety and Tolerability]', 'timeFrame': 'From the start of intervention (Day 1) through the final follow-up (Week 4).', 'description': 'Safety will be assessed by recording the incidence and severity of all adverse events (AEs) reported during the study. AEs include but are not limited to: headache, dizziness, scalp discomfort, tinnitus, irritability, and seizures. Severity will be graded as mild, moderate, or severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Delay Disorder', 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Global Developmental Delay', 'Language Disorders in Children']}, 'descriptionModule': {'briefSummary': "This study explores a safe and effective new approach to improve language function in children with Global Developmental Delay (GDD). Conducted at Xiangxi Autonomous Prefecture People's Hospital, the study will recruit approximately 50 children aged 2 to 5 years. Participants will be randomly assigned to one of two groups: one receiving personalized language training combined with non-invasive, painless repetitive Transcranial Magnetic Stimulation (rTMS) to activate language regions of the brain, and a control group receiving personalized training alongside sham stimulation for comparative analysis. The study spans one month, including a two-week intervention period followed by a two-week follow-up to evaluate the efficacy and sustainability of the combined therapy. This study has been rigorously reviewed and approved by the hospital's Ethics Committee."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Children aged 2-5 years old, regardless of gender.\n2. Meet the diagnostic definition of GDD in China's Diagnostic Guidelines for Global Developmental Delay (2024), confirmed by Gesell Developmental Schedules (GDS). Language domain Developmental Quotient (DQ) ≤ 75. A DQ ≤ 75 is found in at least one of the four developmental domains: gross motor, fine motor, adaptive behavior, and personal-social conduct. Mild-moderate GDD is selected for the study.\n3. The presence of significant language developmental delay, the language ability is significantly lower than children of the same age and the same intellectual level, confirmed by the standardized scale of Sign-Significate Relations (S-S) assessment.\n4. The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems.\n5. Written informed consent obtained from the child's legal guardian. Exclusion Criteria\n\n1\\. History of epilepsy or convulsive seizures. 2. Having metal implants in the skull (e.g. aneurysm clips, metal stents, etc.) and electronic devices such as pacemakers and cochlear implants in the body.\n\n3\\. Other serious neurological conditions that may affect language function (e.g., cerebral palsy, progressive neurological disorders, etc.).\n\n4\\. Have a diagnosis of ASD. 5. Have a severe hearing or visual impairment. 6. Participation in other clinical trials that may affect speech function. 7. Skin lesions or infection at the scalp treatment site. 8. The fontanelle has not yet closed. 9. Previous rTMS treatment in the last 3 months. 10. Developmental quotient \\< 40 in any developmental domains; other circumstances that prevented cooperation with the study."}, 'identificationModule': {'nctId': 'NCT07369960', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Randomized, Double-Blind Controlled Study for Repetitive Transcranial Magnetic Stimulation Combined With Language Training in Children With Language Disorders in Children With Global Developmental Delay', 'orgStudyIdInfo': {'id': 'EC-LCKY2025078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial magnetic stimulation', 'description': 'The stimulation protocol consists of the following parameters: frequency of 10 Hz, intensity at 80% of the resting motor threshold (RMT), 30 pulses per train, 3-second train duration, and a 17-second inter-train interval. Each session comprises 1800 pulses in total, lasting 20 minutes. It will be administered 5 minutes prior to individualized language training to take advantage of the post-stimulation "time window" and potentially enhance training efficacy.', 'interventionNames': ['Behavioral: Transcranial magnetic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Children in the control group will receive sham stimulation using a sham stimulation coil with identical parameters, positioning, and procedures. The sham stimulation will also be administered 5 minutes prior to individualized language training.', 'interventionNames': ['Behavioral: Transcranial magnetic stimulation']}], 'interventions': [{'name': 'Transcranial magnetic stimulation', 'type': 'BEHAVIORAL', 'description': 'The stimulation protocol consists of the following parameters: frequency of 10 Hz, intensity at 80% of the resting motor threshold (RMT), 30 pulses per train, 3-second train duration, and a 17-second inter-train interval. Each session comprises 1800 pulses in total, lasting 20 minutes. In addition to language training, participants will receive High-Frequency rTMS as a group-specific intervention. The rTMS will be administered 5 minutes prior to each language training session to leverage the post-stimulation "time window" and potentially enhance training efficacy. Children in the experimental group will receive active rTMS, while those in the control group will receive sham stimulation. The entire study will last approximately 1 months, including 2 weeks of treatment and 2 weeks of follow-up.', 'armGroupLabels': ['Control group', 'Transcranial magnetic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '416000', 'city': 'Jishou', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shentang Li, MD', 'role': 'CONTACT', 'email': 'lstang0828@126.com', 'phone': '+86 18874093634'}], 'facility': "Xiangxi Autonomous Prefecture People's Hospital, The intersection of Century Avenue and Jianxin Road in Qianzhou Sub-district, Jishou (416000), Hunan, China.", 'geoPoint': {'lat': 28.31925, 'lon': 109.73346}}], 'centralContacts': [{'name': 'Fangkun Liu, MD, MD', 'role': 'CONTACT', 'email': 'liufangkun@csu.edu.cn', 'phone': '+86 15874290600'}], 'overallOfficials': [{'name': 'Fangkun Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': "Xiangxi Autonomous Prefecture People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'shenwailiufangkun', 'investigatorAffiliation': 'Xiangya Hospital of Central South University'}}}}