Neural Changes After Speech Therapy in Patients With Cleft Palate: A Brain Imaging Study

NCT07330687 | Completed

• 1 other identifier: 2017021923
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Cleft palate is one of the most common maxillofacial congenital malformations, which results in severe speech disorders. Compensatory articulation disorder, also known as non-oral articulation disorder (NOA), is considered as the major pathological change among these patients. However, the outcome of speech therapy, an important treatment method, for NOA is often unsatisfactory. This is attributed to the erroneous articulation patterns and entrenched habits in patients with NOA, which require considerable training intensity and time. According to preliminary results from the investigators' own study, as well as studies by others, structural and functional changes have been clearly identified in some brain regions of patients with NOA, suggesting that abnormal neural networks are involved in the progression of NOA. Thus, the investigators proposed the hypothesis that speech therapy effectively corrects articulation disorders through reconfiguration of pathological neural function and reorganization of the abnormal neural network involved in NOA. In this study, multimodal brain imaging techniques will be applied to investigate differences in brain functional connectivity and structural connectivity networks among groups with oral articulation (OA), varying degrees of NOA in postoperative cleft palate patients, and healthy controls. The relationship between improvement in speech intelligibility and alterations in brain networks before and after intervention will be compared. This study aims to reveal the neural network substrates associated with NOA and speech therapy. Overall, through this comprehensive study, the investigators aim not only to provide new insight into the underlying neural mechanism of NOA but also to accumulate evidence for improving the efficacy of speech therapy and discovering new therapeutic strategies in clinical practice.

Conditions

Cleft Lip and/or Palate; Speech Disorder; Speech Therapy; Brain; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Change in Functional Connectivity of the Speech Related Network

  Change in resting-state functional connectivity, focusing on connections between pre-defined speech-related regions (Broca's and Wernicke's areas) and additionally assessed through whole-brain network analysis, using resting-state fMRI data.

  From baseline assessment to post-training assessment (approximately at Week 12)

• Change in Percent Correct Consonants (PCC)

  Change in the percentage of consonants produced correctly, assessed within both single-word and conversational speech contexts. The measure is derived from standardized speech samples, which are evaluated by blinded, certified speech-language pathologists.

  From baseline assessment to post-training assessment (approximately at Week 12)

Secondary Outcomes (5)

• Change in Grey Matter Volume (GMV) of Articulation-Related Regions

  From baseline to post-training assessment (at Week 12)

• Change in Regional Homogeneity (ReHo) in Speech-Related Cortex

  From baseline to post-training assessment (at Week 12)

• Change in Amplitude of Low-Frequency Fluctuations (fALFF)

  From baseline to post-training assessment (at Week 12)

• Change in Proportion of Compensatory Articulation Errors

  From baseline to post-training assessment (at Week 12)

• Change in White Matter Volume (WMV) of Articulation-Related Regions

  From baseline to post-training assessment (at Week 12)

Study Arms (3)

Non-Oral Articulation(NOA) group

EXPERIMENTAL

Participants receive the investigational behavioral intervention: Structured Speech Decompensation Therapy. This one-on-one therapy uses the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits, integrating multisensory cues. The intervention is administered by a certified speech therapist at a dosage of 1-hour sessions, with a frequency of 3 sessions per week, for a duration of 5 to 12 weeks. Parent participation in sessions and daily prescribed home practice are required components.

Behavioral: Structured Speech Training for Decompensation

Oral Articulation (OA) Group

NO INTERVENTION

Participants do not receive the investigational speech training intervention. This arm serves as the clinical control group.

healthy control(HC)

NO INTERVENTION

Participants do not receive any study-related intervention. This arm serves as the healthy normative control group.

Interventions

Structured Speech Training for Decompensation BEHAVIORAL

This structured, one-on-one speech decompensation therapy targets Non-oral Articulation Disorder (NOA) in postoperative cleft palate patients, using the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits. It follows a structured paradigm from error recognition to generalization, integrating multisensory cues. Delivered by a therapist 3 times/week for 1 hour over 5-12 weeks with parent participation, it includes daily home practice. Completion requires accurate sound production, with daily parent-supervised maintenance practice for one year thereafter.

Non-Oral Articulation(NOA) group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 4 and 16 years.
• For patient groups: Diagnosed with non-syndromic cleft palate and having undergone cleft palate repair surgery at least 1 year prior.
• For the NOA group: Diagnosed with compensatory articulation disorder (Non-oral Articulation, NOA) through standardized speech assessment.
• For the OA group: Confirmed to have no compensatory articulation disorder (Oral Articulation, OA) through standardized speech assessment.
• For the healthy control group: No history of any craniofacial malformations, speech disorders, or neurological diseases.
• Participants and their legal guardians are able to understand and willing to provide written informed consent.
• Able to cooperate with and complete magnetic resonance imaging (MRI) examinations (e.g., no claustrophobia, no contraindicated metal implants).

You may not qualify if:

• Presence of other known syndromes or cognitive impairments (e.g., autism spectrum disorder, intellectual disability).
• History of other neurological diseases that may affect speech function (e.g., cerebral palsy, hearing loss).
• Presence of severe other orofacial anomalies, or an unrepaired palatal fistula.
• Contraindications for MRI examination (e.g., non-removable metal implants, severe claustrophobia).
• Having received systematic speech therapy within the past 6 months.
• Any other condition deemed by the investigator to be unsuitable for participation in the study.

Sponsors & Collaborators

• Shufan Zhao: lead
• Wenzhou Medical University: collaborator
• National Natural Science Foundation of China: collaborator
• Guangzhou Women and Children's Medical Center: collaborator

Study Sites (1)

School & Hospital of Stomatology Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (6)

• Zhang W, Li C, Chen L, Xing X, Li X, Yang Z, Zhang H, Chen R. Increased activation of the hippocampus during a Chinese character subvocalization task in adults with cleft lip and palate palatoplasty and speech therapy. Neuroreport. 2017 Aug 16;28(12):739-744. doi: 10.1097/WNR.0000000000000832.

  PMID: 28658048 RESULT

• Wang Y, Deng C, Li H, Gao Y, Shi B, Huang X, Gong Q. Intranetwork and Internetwork Functional Connectivity Changes Related to Speech Disorders in Adults With Cleft Lip and Palate. Eur J Neurosci. 2025 Apr;61(7):e70077. doi: 10.1111/ejn.70077.

  PMID: 40219708 RESULT

• Zhang W, Guan Z, Cao L, Sun L, Zhang X, Chen R, Li C, Song W. Articulation-function-associated brain developmental changes in cleft lip and palate patients. Brain Res Bull. 2025 Sep;229:111458. doi: 10.1016/j.brainresbull.2025.111458. Epub 2025 Jul 11.

  PMID: 40653058 RESULT

• Zhang W, Zhao C, Sun L, Yang X, Yang L, Liang Y, Zhang X, Du X, Chen R, Li C. Articulation-Function-Associated Cortical Developmental Changes in Patients with Cleft Lip and Palate. Brain Sci. 2023 Mar 25;13(4):550. doi: 10.3390/brainsci13040550.

  PMID: 37190514 RESULT

• Wang S, Fang L, Miao G, Li Z, Rao B, Cheng H. Atypical cortical thickness and folding of language regions in Chinese nonsyndromic cleft lip and palate children after speech rehabilitation. Front Neurol. 2022 Sep 20;13:996459. doi: 10.3389/fneur.2022.996459. eCollection 2022.

  PMID: 36203989 RESULT

• Homoud NN, Ireland AJ, Sherriff M, AlSaffar Z, Davies AJV, Sandy JR. A Review and Meta-Analysis on Altered Brain Structure in Patients Born with Non-Syndromic Cleft Lip and/or Palate. Cleft Palate Craniofac J. 2025 Mar 24:10556656251327526. doi: 10.1177/10556656251327526. Online ahead of print.

  PMID: 40129165 RESULT

MeSH Terms

Conditions

Speech Disorders; Communication Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Attending Physician

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 6, 2019
• Primary Completion: May 27, 2021
• Study Completion: August 21, 2021
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)