Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 2:04 AM
Study NCT ID:
NCT07069257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D012798', 'term': 'Sialorrhea'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are blinded to group assignment. The clinician performing ultrasound assessments is also blinded. The therapist delivering the interventions and administering the scales is not blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to three parallel groups: (1) oral motor therapy plus neuromuscular electrical stimulation (NMES), (2) oral motor therapy alone, and (3) oral motor therapy plus sham NMES.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Drooling Severity and Frequency Scale (DSFS) Score', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'The Drooling Severity and Frequency Scale (DSFS) is a validated tool assessing drooling severity (1-5) and frequency (1-4). Higher scores indicate more severe drooling.'}, {'measure': 'Change in Drooling Impact Scale (DIS) Score', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'The DIS assesses the impact of drooling on daily life, with higher scores indicating greater negative impact.'}], 'secondaryOutcomes': [{'measure': 'Change in Orofacial Muscle Thickness Measured by Ultrasound', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'Ultrasound measurement of masseter and orbicularis oris muscle thickness to evaluate changes in muscle structure following intervention.'}, {'measure': 'Change in Visual Analog Scale (VAS) Drooling Severity Score', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'Participants or caregivers rate drooling severity on a 0-10 visual analog scale, where higher scores indicate more severe drooling.'}, {'measure': 'Change in Drooling Quotient (DQ5)', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'The Drooling Quotient (DQ5) assesses the percentage of time drooling occurs during a 5-minute observation period. Higher percentages indicate more frequent drooling.'}, {'measure': 'Change in Karaduman Chewing Performance Scale (KCPS) Score', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'The Karaduman Chewing Performance Scale (KCPS) evaluates chewing function in children with cerebral palsy, scored from Level 1 (normal chewing) to Level 4 (severely impaired chewing).'}, {'measure': 'Change in Tongue Thrust Rating Scale (TTRS) Score', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'The Tongue Thrust Rating Scale (TTRS) assesses tongue thrust reflex severity during swallowing. Higher scores indicate more pronounced tongue thrusting.'}, {'measure': 'Change in Daily Number of Wet Bibs and Cloths', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'The total number of bibs and cloths used daily due to drooling, recorded by caregivers. Higher counts reflect increased drooling severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Drooling', 'Sialorrhea', 'Oral Motor Therapy', 'Neuromuscular Electrical Stimulation', 'Pediatric Rehabilitation', 'Ultrasound', 'Masseter Muscle', 'Orbicularis Oris Muscle'], 'conditions': ['Cerebral Palsy (CP)', 'Drooling']}, 'referencesModule': {'references': [{'pmid': '36357332', 'type': 'BACKGROUND', 'citation': 'Assoratgoon I, Shiraishi N, Tagaino R, Ogawa T, Sasaki K. Sensory neuromuscular electrical stimulation for dysphagia rehabilitation: A literature review. J Oral Rehabil. 2023 Feb;50(2):157-164. doi: 10.1111/joor.13391. Epub 2022 Nov 28.'}, {'pmid': '24101813', 'type': 'BACKGROUND', 'citation': 'Sigan SN, Uzunhan TA, Aydinli N, Eraslan E, Ekici B, Caliskan M. Effects of oral motor therapy in children with cerebral palsy. Ann Indian Acad Neurol. 2013 Jul;16(3):342-6. doi: 10.4103/0972-2327.116923.'}, {'type': 'BACKGROUND', 'citation': '2. Awan, W. A., Aftab, A., Janua, U. I., Ramzan, R., & Khan, N. (2017). EFFECTIVENESS OF KINESIO TAPING WITH OROMOTOR EXERCISES IN IMPROVING DROOLING AMONG CHILDREN WITH CEREBRAL PALSY: soi: 21-2017/re-trjvol01iss02p21. The Rehabilitation Journal, 1(02), 21-27.'}, {'type': 'BACKGROUND', 'citation': '1. Fatima et al (2019), Study of the effectiveness of oromotor exercises to reduce drooling in cerebral palsy children'}]}, 'descriptionModule': {'briefSummary': 'This randomized, controlled, single-blind trial aims to investigate the effectiveness of neuromuscular electrical stimulation (NMES) combined with oral motor therapy in reducing drooling severity among children with cerebral palsy. Participants will be allocated to an intervention group (oral motor therapy plus NMES), a control group (oral motor therapy alone) and a sham group (oral motor therapy with placebo NMES).', 'detailedDescription': 'Drooling is a common and disabling problem in children with cerebral palsy, adversely affecting health, social participation, and quality of life. Oral motor therapy is frequently used to improve oral control, and neuromuscular electrical stimulation (NMES) has been suggested as an adjunctive treatment to enhance orofacial muscle function.\n\nThis randomized, controlled, single-blind study will include children aged 4 to 17 years diagnosed with cerebral palsy and presenting with moderate to severe drooling (Drooling Severity and Frequency Scale score ≥3). Participants will be randomly assigned to one of three groups: oral motor therapy alone, oral motor therapy plus active NMES, and oral motor therapy with sham NMES. The intervention comprises twelve therapy sessions over four weeks, delivered by a trained therapist.\n\nOral motor therapy involves exercises targeting lips, tongue, cheeks, and jaw, in addition to thermal and tactile stimulation (using brushes, spoons, cold packs, and heat packs). NMES will be applied bilaterally to the masseter muscles and to the orbicularis oris muscle using a Chattanooga NMES device. Sham NMES will simulate the procedure without delivering active stimulation.\n\nOutcome measures will be assessed before and after the intervention and will include both subjective and objective drooling scales: Drooling Severity and Frequency Scale (DSFS), Drooling Impact Scale (DIS), Visual Analog Scale for drooling severity, Drooling Quotient (DQ5), and caregiver reports of bib usage. Orofacial muscle thickness will be measured with ultrasound imaging. Additional assessments will include functional classification systems (GMFCS, MACS, CFCS, VFCS, EDACS, FOIS) and the Pediatric Eating Assessment Tool (PEDI EAT-10).\n\nThis study is approved by the Ethics Committee of Istanbul Medipol University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cerebral palsy (unilateral/bilateral spastic, ataxic, dyskinetic, or mixed type)\n* Presence of drooling control problems\n* Age between 4 and 17 years\n* Gross Motor Function Classification System (GMFCS) levels 2, 3, 4, or 5\n* Stable drooling severity for at least one month prior to enrollment\n* Drooling Severity and Frequency Scale (DSFS) score of 3 or higher\n\nExclusion Criteria:\n\n* Diagnosis of dysphagia\n* Use of medications affecting drooling within the past 72 hours\n* Upper respiratory tract infection and/or salivary gland infection during the study period\n* History of botulinum toxin injection to the salivary glands'}, 'identificationModule': {'nctId': 'NCT07069257', 'acronym': 'NOMES-CP', 'briefTitle': 'Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Children With Cerebral Palsy Experiencing Drooling Problems: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-SP-SC-NMESOMT-01'}, 'secondaryIdInfos': [{'id': 'Ethics Committee No: 1295 (20-', 'type': 'OTHER', 'domain': 'Ethics Committee of Istanbul Medipol University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Motor Therapy Plus NMES', 'description': 'Participants assigned to this arm will receive oral motor therapy combined with active neuromuscular electrical stimulation (NMES) applied to the masseter and orbicularis oris muscles.', 'interventionNames': ['Behavioral: Oral Motor Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Motor Therapy Only', 'description': 'Participants assigned to this arm will receive oral motor therapy without any NMES.', 'interventionNames': ['Behavioral: Oral Motor Therapy', 'Device: Neuromuscular Electrical Stimulation (NMES)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Oral Motor Therapy Plus Sham NMES', 'description': 'Participants assigned to this arm will receive oral motor therapy combined with sham NMES that does not deliver active stimulation.', 'interventionNames': ['Behavioral: Oral Motor Therapy', 'Device: Sham Neuromuscular Electrical Stimulation (Sham NMES)']}], 'interventions': [{'name': 'Oral Motor Therapy', 'type': 'BEHAVIORAL', 'description': 'Structured oral motor exercises will be applied to the lips, tongue, cheeks, and jaw. Facial massage and thermal stimulation (warm and cold) will be performed. Intraoral sensory stimulation will be applied using a brush, lemon juice, and a cold metal probe.', 'armGroupLabels': ['Oral Motor Therapy Only', 'Oral Motor Therapy Plus NMES', 'Oral Motor Therapy Plus Sham NMES']}, {'name': 'Neuromuscular Electrical Stimulation (NMES)', 'type': 'DEVICE', 'description': "Active NMES will be applied bilaterally to the masseter muscles and to the orbicularis oris muscle in addition to oral motor therapy sessions, using a Chattanooga NMES device. Each application will be performed in cycles of 5 seconds of stimulation and 10 seconds of rest. The stimulation parameters will be set to a frequency of 10-15 Hz and a pulse width of 300 microseconds. The current intensity will be gradually increased to a level just above the motor threshold, sufficient to elicit a noticeable pulling sensation without causing discomfort, and will be adjusted according to each participant's tolerance. NMES will be delivered for a total duration of 15 minutes per session. For the electrical stimulation of the orbicularis oris muscle, a pen-type electrode will be used. In this procedure, four regions of the orbicularis oris muscle (upper, lower, right, and left) will be stimulated in two cycles of 45 pulses each.", 'armGroupLabels': ['Oral Motor Therapy Only']}, {'name': 'Sham Neuromuscular Electrical Stimulation (Sham NMES)', 'type': 'DEVICE', 'description': 'Simulated neuromuscular electrical stimulation will be applied without delivering active electrical current after oral motor therapy sessions to mimic the treatment experience without producing physiological effects.', 'armGroupLabels': ['Oral Motor Therapy Plus Sham NMES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Ataşehir', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zehra Aycan', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Esra Giray, Assoc. Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aslinur Keles, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fatih Sultan Mehmet Training and Research Hospital', 'geoPoint': {'lat': 40.9833, 'lon': 29.1167}}], 'centralContacts': [{'name': 'ZEHRA AYCAN', 'role': 'CONTACT', 'email': 'zehrabir.123@gmail.com', 'phone': '+90 553 450 00 22'}], 'overallOfficials': [{'name': 'Zehra Aycan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}, {'name': 'Esra Giray, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital'}, {'name': 'Aslinur Keles Ercisli, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to confidentiality concerns and institutional data sharing policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}