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临床试验/NCT00306501
NCT00306501已完成2 期

Induction of Volitional Swallowing in Chronic Dysphagia Post Stroke: A Novel Mechanism-Based Intervention

National Institute of Neurological Disorders and Stroke (NINDS)2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2006年3月17日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
34
试验地点
2
主要终点
Swallowing safety

研究概览

简要总结

This study will compare several techniques designed to improve the ability to swallow in stroke patients with chronic dysphagia (difficulty swallowing).

Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a stroke resulting in swallowing problems may be eligible for this study. Volunteers are screened with a medical history, physical examination, and urine test for women to rule out pregnancy. Stroke patients are screened additionally with a chest x-ray, physical examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of the nasal passages in the back of the throat using a lighted telescopic instrument) and FEESST (passage of a thin, flexible telescope through the nose to the voice box), videofluoroscopy (x-ray of the head and neck during swallowing) and button press training (learning how to press a button on a table in coordination with swallowing).

All participants undergo the following procedures:

  • Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a pulse of energy to the brain through the scalp. The muscle response to the pulse is recorded from the muscles in the throat that are associated with swallowing.
  • Electromyography: A needle is used to insert tiny wires in specific muscles of the throat to record the muscle response to the TMS pulses.
  • Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and images of the brain are taken.

In addition to the above tests, stroke patients undergo the following:

  • Water test: The subject swallows a small amount of water and the number of times required to clear the throat or cough is counted. This test is repeated five times.

  • Experimental training. Subjects have a total of 12 60-minute training sessions, one session a day for up to 5 sessions a week.

  • Button press training: The subject swallows small amounts of water. A device placed on the throat senses when swallowing occurs. The subject learns how to coordinate pressing a button on a table in coordination with swallowing.

  • Vibrotactile stimulator training: A device that uses a buzzing vibration is placed on the throat at times during the swallowing training.

  • Transcranial direct current stimulation (tDCS): Wires attached to sponge electrodes are placed on the scalp and over the eye. Small electric currents are delivered to areas of the brain involved with swallowing. This is done at times during the swallowing training.

Participants may receive one of several combinations of training approaches; all receive the volitional (button-press) training. Within 5 days of completing training, subjects repeat the tests. TMS, MRI, MEG and x-ray study of swallowing function are also repeated to see if any changes have occurred in the brain or in the ability to swallow after training. Patients are contacted by telephone and in writing 3 and 6 months after training for follow-up on their swallowing status and oral intake.

详细描述

Objectives:

Chronic pharyngeal dysphagia is a life threatening disorder following brain injury. Repeated occurrences of aspiration pneumonia result in expensive hospital stays and reduced survival. The purpose of this investigation is to compare two novel training methods: 1) training to initiate swallowing while pressing a switch; 2) training to initiate swallowing while pressing a switch with coincident peripheral vibrotactile stimulation.

Some preliminary studies will be conducted in healthy volunteers to determine the feasibility of using near infrared spectroscopy (fNIRS) for measuring change in brain activation for swallowing before and after treatment and to determine the physiological effects of direct current stimulation on brain activation for swallowing, during sensory stimulation and at rest.

Patients will be randomly assigned to one of two training groups and the results of 12 training sessions will be contrasted using blinded assessment. The hypothesis being tested is that training methods involving simultaneous peripheral-sensory stimulation will reduce the risk of aspiration or penetration during swallowing in patients with chronic pharyngeal dysphagia post brain injury.

Two additional questions address the neural mechanisms involved in the training effects. To determine whether changes occur in cortical control of the hyo-laryngeal musculature involved in swallowing, patients will also be studied before and after training using transcranial magnetic stimulation to assess muscle responses to cortical stimulation. Finally, to determine if training effects are related to changes in cortical neuroplasticity, we will use near infrared spectroscopy to measure functional change in brain activation in M1, for swallowing to determine if cortical control is enhanced in the different training groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Swallowing safety

时间窗: Immediately following training

次要结局

  • SWAL_QUAL Patient questionnaire(Immediately following training and 3 months later)

研究者

研究点 (2)

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