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Completed Phase 2 Interventional

Volitional Swallowing in Stroke Patients With Chronic Dysphagia

ClinicalTrials.gov ID: NCT00306501

Public ClinicalTrials.gov record NCT00306501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 4:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00306501
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
34 participants

Conditions and interventions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 16, 2006
Primary completion
Dec 15, 2009
Completion
Dec 15, 2009
Last update posted
Jul 1, 2017

2006 – 2009

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00306501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2017 · Synced Sep 9, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00306501 live on ClinicalTrials.gov.

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