Cerebral Palsy (CP)NOMES-CPNCT07069257
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
A study testing Oral Motor Therapy and Neuromuscular Electrical Stimulation (NMES) in people with Cerebral Palsy (CP) and Drooling, run by Aslinur Keles Ercisli, MD, PhD at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP), Drooling
- What is being tested?
- Oral Motor Therapy and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of cerebral palsy (unilateral/bilateral spastic, ataxic, dyskinetic, or mixed type)
- Presence of drooling control problems
- Age between 4 and 17 years
- Gross Motor Function Classification System (GMFCS) levels 2, 3, 4, or 5
- Stable drooling severity for at least one month prior to enrollment
- Drooling Severity and Frequency Scale (DSFS) score of 3 or higher
Who cannot join
- Diagnosis of dysphagia
- Use of medications affecting drooling within the past 72 hours
- Upper respiratory tract infection and/or salivary gland infection during the study period
- History of botulinum toxin injection to the salivary glands
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aslinur Keles contact
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Ataşehir, Istanbul, 34758
Zehra Aycan
Esra Giray, Assoc. Prof.
About this study
Official title: Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Children With Cerebral Palsy Experiencing Drooling Problems: A Randomized Controlled Trial
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).
Read the detailed description
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.
This 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.
Oral 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.
Outcome 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).
This study is approved by the Ethics Committee of Istanbul Medipol University.
- Conditions
- Cerebral Palsy (CP), Drooling
- Being tested
- Oral Motor Therapy, Neuromuscular Electrical Stimulation (NMES), Sham Neuromuscular Electrical Stimulation (Sham NMES)
- Keywords
- Cerebral Palsy, Drooling, Sialorrhea, Oral Motor Therapy, Neuromuscular Electrical Stimulation, Pediatric Rehabilitation, Ultrasound, Masseter Muscle, Orbicularis Oris Muscle
- Medical subject headings
- Cerebral Palsy, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Motor TherapyBehavioural
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.
Neuromuscular Electrical Stimulation (NMES)Device
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.
Sham Neuromuscular Electrical Stimulation (Sham NMES)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Motor Therapy Plus NMES | Experimental | 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. Receives: Behavioral: Oral Motor Therapy; Device: Neuromuscular Electrical Stimulation (NMES) |
| Oral Motor Therapy | Other | Participants assigned to this arm will receive oral motor therapy without any NMES. This is a behavioral therapy. Receives: Behavioral: Oral Motor Therapy |
| Oral Motor Therapy Plus Sham NMES | Sham comparator | Participants assigned to this arm will receive oral motor therapy combined with sham NMES that does not deliver active stimulation. Receives: Behavioral: Oral Motor Therapy; Device: Sham Neuromuscular Electrical Stimulation (Sham NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drooling Severity and Frequency Scale (DSFS) Score
The Drooling Severity and Frequency Scale (DSFS) is a validated clinical tool that assesses drooling in two domains: severity and frequency.
Severity is rated on a 5-point scale from 1 (dry; never drools) to 5 (profuse; clothing, hands, tray, and objects wet).
Frequency is rated on a 4-point scale from 1 (never) to 4 (constantly). Higher scores in each subscale indicate more severe and frequent drooling. The total score reflects the combined impact of both dimensions.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Change in Drooling Impact Scale (DIS) Score
The Drooling Impact Scale (DIS) assesses the impact of drooling on daily life. It consists of 10 items, each scored from 1 (barely) to 10 (extremely), resulting in a total score range of 10 to 100. Higher scores indicate a greater negative impact of drooling on quality of life.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Secondary outcomes (6)
Change in Orofacial Muscle Thickness Measured by Ultrasound
Ultrasound measurement of masseter and orbicularis oris muscle thickness to evaluate changes in muscle structure following intervention.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Change in Visual Analog Scale (VAS) Drooling Severity Score
Participants or caregivers rate the perceived severity of drooling using a 10 cm visual analog scale (VAS), ranging from 0 (no drooling) to 10 (extremely severe drooling). Higher scores indicate greater severity of drooling. The VAS is a widely used subjective assessment tool in clinical settings.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Change in Drooling Quotient (DQ5)
The Drooling Quotient (DQ5) is an observational measure used to quantify the frequency of drooling in individuals with drooling disorders. Observations are conducted during two separate 5-minute periods: one during rest (passive state) and one during activity (active state such as talking or playing).
During each 5-minute period, the presence or absence of drooling is recorded every 15 seconds, for a total of 20 intervals per condition. The DQ5 is calculated as the percentage of intervals in which drooling is observed (e.g., drooling observed in 6 out of 20 intervals = 30%). Higher percentages indicate more frequent drooling. Scores from both rest and activity conditions are reported.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Change in Karaduman Chewing Performance Scale (KCPS) Score
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).
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Change in Tongue Thrust Rating Scale (TTRS) Score
The Tongue Thrust Rating Scale (TTRS) is a clinician-rated observational tool used to assess the severity of tongue thrust during swallowing. It is scored on a 3-point scale:
- = No tongue thrust,
- = Mild; tongue positioned between the teeth,
- = Moderate; tongue positioned between the lips. Higher scores indicate more pronounced tongue thrust behavior during swallowing.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Change in Daily Number of Wet Bibs and Cloths
The total number of bibs and cloths used daily due to drooling, recorded by caregivers. Higher counts reflect increased drooling severity.
Measured: At Baseline and at 4th Week (after completion of 12 therapy sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aslinur Keles Ercisli, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Fatih Sultan Mehmet Training and Research Hospital
- Responsible party
- Sponsor-investigator, Aslinur Keles Ercisli, MD, PhD, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Zehra Aycan, Principal investigator, Health Sciences University Fatih Sultan Mehmet Training and Research HospitalEsra Giray, Assoc. Prof., Study chair, Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research HospitalAslinur Keles Ercisli, MD, PhD, Study director, Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069257
- Sponsor's protocol ID
- 2025-SP-SC-NMESOMT-01
- Other IDs
- Ethics Committee No: 1295 (20-
- Acronym
- NOMES-CP
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to confidentiality concerns and institutional data sharing policies.
Publications
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.
PubMed 36357332Sigan 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.
PubMed 241018132. 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.
1. Fatima et al (2019), Study of the effectiveness of oromotor exercises to reduce drooling in cerebral palsy children