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Dysphagia clinical trials

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NCT ID: NCT04164420 Completed - Stroke Clinical Trials

Oral Neuromuscular Training in Stroke Patients With Dysphagia

Start date: December 2006
Phase: N/A
Study type: Interventional

This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia. Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.

NCT ID: NCT04086355 Completed - Dysphagia Clinical Trials

Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy

CP
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This study was conducted to evaluate the effectiveness of masticatory muscles electrical stimulation on oromotor skills, feeding level progress and child growth in children with dyaphagia. Forty children diagnosed as spastic cerebral palsy, from both genders, age ranging from 2 to 5 years were enrolled in the current study. They were randomly allocated in to study group (A) received oromotor exercises and neuromuscular electrical stimulation on masseter and digastric muscles and control group (B) received same exercises but placebo electrical stimulation. The result showed significant improvement in all variables in both groups. However, the study group showed significant different in feeding level in compare with control group.

NCT ID: NCT04052178 Completed - Stroke Clinical Trials

Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia.

FIS2014
Start date: February 10, 2016
Phase: N/A
Study type: Interventional

Study design: Multicenter, experimental, randomized, crossed, double blind study (patient and results analysis). Aim: To evaluate the effect of different neurostimulation techniques on the neurophysiological and biomechanical swallowing mechanisms of patients with dysphagia associated with chronic stroke and select those techniques with the best results to be evaluated in the second phase of the study (medium-term effects). Outcome measures: - Videofluoroscopy: prevalence of impaired efficacy and safety of swallow (penetrations and aspirations), penetration aspiration scale (PAS: from 0 to 8), biomechanical parameters (time to laryngeal vestibule closure, upper esophageal sphincter opening). - Pharyngeal sensory evoked potentials (pSEP): latency and amplitude of obtained evoked potentials. Higher latency (0 onwards) means worse outcome and higher amplitude (0 onwards) means better outcome. - Pharyngeal motor evoked potentials (pMEP): latency, amplitude, duration and area of obtained evoked potentials. Higher latency (0 onwards) means worse outcome and higher amplitude (0 onwards) means better outcome. Treatments and patients: 36 post-stroke patients with oropharyngeal dysphagia (PAS superior or equal to 2) randomized patients in 3 treatment arms (3 groups of 12 patients). - Active and sham repetitive transcranial magnetic stimulation (rTMS): 90% of the resting motor threshold, 1250 pulses, 5 Hz. - Active and sham Intrapharyngeal Electrical Stimulation (PES): 75% of tolerance threshold, pulses of 0.2 ms, 5 Hz, 10 min. - Oral Capsaicin (active intervention, 10-5M, TRPV1 agonist) and placebo solution (sham): 100 mL, single administration. Administration of study therapies: The study will be performed in two visits separated for one week. In each visit patients will randomly receive active or sham treatment and a pre-post evaluation of biomechanics of deglutition (with VFS) and neurophysiological mechanisms (swallowing afferent and efferent pathways) will be performed in each visit. Acute randomized administration -> 1 active session (pre/post evaluation with VFS/pSEP/pMEP) + 1 separate control session 1 week apart (pre/post evaluation with VFS/pSEP/pMEP).

NCT ID: NCT04040803 Completed - Dysphagia Clinical Trials

tACS and tRNS Studies on Brain Control of Swallowing

Start date: May 3, 2019
Phase: N/A
Study type: Interventional

Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory. Swallowing problems are life-threatening symptom among patients with brain impairments and elderly people. Until now, there are no studies investigating whether tACS and tRNS can have a beneficial effect on swallowing function in human. Our aim is to examine the effects of different strengths of tACS and tRNS to determine the best approach for brain stimulation that controls swallowing action, before using these techniques in patients with (neurological) swallowing disorders. Participants: Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.

NCT ID: NCT03997188 Completed - Clinical trials for Breast Cancer Female

Zinc-L-Carnosine Prevents Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Start date: December 21, 2015
Phase: Phase 3
Study type: Interventional

Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients.

NCT ID: NCT03889041 Completed - Quality of Life Clinical Trials

Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Start date: April 1, 2019
Phase:
Study type: Observational

Children with esophageal atresia and tracheoesophageal fistula (EA-TEF) may experience feeding and swallowing difficulties, which result in stressful interactions between children and caregivers, and potentially impact the concerns of caregivers. The aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

NCT ID: NCT03882450 Completed - Dysphagia Clinical Trials

Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.

NCT ID: NCT03834896 Completed - Dysphagia Clinical Trials

Madrid - Tolerance and Acceptability Study

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Tolerance and Acceptability of a gum based thickener.

NCT ID: NCT03831789 Completed - Dysphagia Clinical Trials

The Effects of Bilateral Cerebellar rTMS on Cortical Function

Start date: April 8, 2019
Phase: N/A
Study type: Interventional

Swallowing function is controlled by two swallowing centres (one on each half of the brain). There is a dominant and non-dominant swallowing centre. Damage to any part of the brain can lead to swallowing problems, for example in strokes. Recovery of the ability to swallow is associated with increased activity (compensation) over the undamaged centre. The cerebellum is an area of the brain involved in the control and modulation of muscle movements. It is found at the back of the skull. Over the past few years studies have tried to improve swallowing function using techniques to stimulate regions of the brain and encourage compensation. Repetitive transcranial magnetic stimulation (rTMS) is a technique which can temporarily increase or suppress activity over regions of the brain. This study will use cerebellar rTMS to attempt to increase activity over the cortical swallowing centres. It will also temporarily suppress activity over the dominant swallowing centre (a virtual lesion) before using cerebellar targeted rTMS to attempt to reverse this suppressive electrical and behavioural effect. The investigators aim to compare the effectiveness of rTMS over the two halves of the cerebellum to rTMS over one half of the cerebellum in increasing activity over the swallowing centres and reversing the suppressive effects of low frequency rTMS 'virtual lesion' over the dominant swallowing centre.

NCT ID: NCT03753841 Completed - Dysphagia Clinical Trials

FEES to Determine Neurological Intensive Care Patients' Oral Diet

Start date: January 14, 2014
Phase: N/A
Study type: Interventional

Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.