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

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.

NCT Number	NCT07330687
Lead Sponsor	Shufan Zhao Collaborators: Guangzhou Women and Children's Medical Center, Wenzhou Medical University, National Natural Science Foundation of China
Conditions	Cleft Lip and/or Palate, Speech Disorder, Speech Therapy, Brain, Magnetic Resonance Imaging
Enrollment	164 participants
Start Date	2019-01-06
Primary Completion	2021-05-27 (estimated)
Study Completion	2021-08-21 (estimated)
Updated on ClinicalTrials.gov	2026-02-03