StrokePhase 2NCT00306501
Volitional Swallowing in Stroke Patients With Chronic Dysphagia
A Phase 2 study testing Swallowing Training in people with Stroke and Dysphagia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Swallowing Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2006to 16 Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusive ages of 18 to 75
- The healthy volunteers will be without cardiac, neurological, psychiatric, speech or swallowing problems as determined by medical history and examination by a physician
Who cannot join
- History of epileptic seizure
- History of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) or a cardiac pacemaker in place
- History of past brain injury or neurological disorders
- Currently on medications for a psychiatric disorder
- Presence of progressive neurodegenerative disorders, such as dementia, Parkinson's Disease, multiple sclerosis, peripheral neuropathy, and amyotrophic lateral sclerosis
- History of swallowing problems
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- Pregnant women will be excluded from participation because the study involves MRI
- Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) and presence of certain tattoos with ferromagnetic metal or permanent makeup will exclude subjects from participating in MRI and TMS procedures due to the exposure to high magnetic force through these procedures. Subjects who were metal workers as a previous occupation will also be excluded from MRI and TMS due to the possibility of unknown/undetected metal in their body.
- Presence of broken skin in the area of the tDCS or TMS stimulating electrodes will exclude persons from those procedures.
- Presence of darkly pigmented skin as defined by types V-VI on the Fitzpatrick scale will exclude subjects from participating in fNIRs. A skin type of V-VI will not exclude healthy volunteers from participating in other study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Induction of Volitional Swallowing in Chronic Dysphagia Post Stroke: A Novel Mechanism-Based Intervention
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).
Read more
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.
Read the detailed description
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.
Study Population:
Healthy volunteers and patients with chronic pharyngeal dysphagia following brain injury will be studied.
Design:
Healthy control subjects will be assessed first in three studies:
- A study comparing the effects of air puff versus vibrotactile stimulation on inducing swallowing
- A study of the transcranial magnetic stimulation to elicit responses from pharyngeal and submental muscles
- A study using near infrared spectroscopy to examine brain activation responses to sensory stimulation, brain laterality for swallowing and the effects of transcranial direct current stimulation (tDCS) on brain responses to sensory stimulation and brain activation for swallowing.
Patients with chronic pharyngeal dysphagia following brain injury will participate in a clinical trial evaluating swallowing motor retraining with and without sensory stimulation. This study will be a randomized, blinded Phase 2 clinical trial in which patients will be assigned to two training conditions: training with sham sensory stimulation and training with vibrotactile sensory stimulation.
A non-invasive, external vibrotactile stimulator on the throat will provide external sensory stimulation. Pre-training testing, training sessions, and post-training testing will be provided in up to 20 visits for each subject.
Outcome Measures:
The primary outcome variables will be measures of swallowing function before and after training and at 3 and 6 months post training. These will include the NIH Swallowing Safety Scale scored from masked videofluoroscopy recordings and the Water Test, a non-invasive assessment of swallowing. Both will be scored by speech pathologists blinded to patient training group identity or condition before or after training.
To assess the relationship of improvements in training with changes in neuronal function, transcranial magnetic stimulation with surface electromyography recordings will be used to assess changes in corticobulbar conduction following training.
To assess whether functional activation within the brain (particularly in the region of M1) is related to improvement in swallowing following each type of training, near infrared spectroscopy NIRS will be used to examine blood oxygenation level dependent changes in brain function for swallowing following training. All outcome measures will be scored without knowledge of training group or condition (pre vs. post training or training group).
- Being tested
- Swallowing Training
- Keywords
- Training, Cortical Stimulation, Sensory Stimulation, Brain Imaging, Transcranial Magnetic Stimulation (TMS), Swallowing, Dysphagia, Stroke, CVA, Cerebral Vascular Accident, Healthy Volunteer, HV
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing TrainingProcedure or surgery
Swallowing Training with press of button
| Study group | Role | What they receive |
|---|---|---|
| Button Press | Other | Training with button press Receives: Procedure: Swallowing Training |
| Vibtrotactile | Other | Sensory Stimulation - Vibrotactile device with button press to initiate swallowing during retraining Receives: Procedure: Swallowing Training |
| Cortical Stimulation | Other | Training with Cortical stimulation - cortical stimulation during training with button press Receives: Procedure: Swallowing Training |
| Combined | Other | Combined vibrotactile and cortical stimulation with button press training Receives: Procedure: Swallowing Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing safety
Measured: Immediately following training
Secondary outcomes (1)
SWAL_QUAL Patient questionnaire
Measured: Immediately following training and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study start17 Mar 2006
- Primary completion16 Dec 2009
- Study completion16 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306501
- Sponsor's protocol ID
- 060120
- Other IDs
- 06-N-0120
- Status last verified
- 29 Oct 2010
- First submitted
- 22 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Adkins-Muir DL, Jones TA. Cortical electrical stimulation combined with rehabilitative training: enhanced functional recovery and dendritic plasticity following focal cortical ischemia in rats. Neurol Res. 2003 Dec;25(8):780-8. doi: 10.1179/016164103771953853.
PubMed 14669519Agnew WF, McCreery DB. Considerations for safety with chronically implanted nerve electrodes. Epilepsia. 1990;31 Suppl 2:S27-32. doi: 10.1111/j.1528-1157.1990.tb05845.x.
PubMed 2226363Aydogdu I, Ertekin C, Tarlaci S, Turman B, Kiylioglu N, Secil Y. Dysphagia in lateral medullary infarction (Wallenberg's syndrome): an acute disconnection syndrome in premotor neurons related to swallowing activity? Stroke. 2001 Sep;32(9):2081-7. doi: 10.1161/hs0901.094278.
PubMed 11546900
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Volitional Swallowing in Chronic Dysphagia Post Stroke: A Novel Mechanism-Based Intervention
- ClinicalTrials.gov ID
- NCT00306501
- Acronym / sponsor ID
- 060120
- Keywords
- Training, Cortical Stimulation, Sensory Stimulation, Brain Imaging, Transcranial Magnetic Stimulation (TMS), Swallowing, Dysphagia, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 17 Mar 2006
- Primary completion
- 16 Dec 2009 (actual)
- Study completion
- 16 Dec 2009 (actual)
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study Population:
Healthy volunteers and patients with chronic pharyngeal dysphagia following brain injury will be studied.
Design:
Healthy control subjects will be assessed first in three studies:
- A study comparing the effects of air puff versus vibrotactile stimulation on inducing swallowing
- A study of the transcranial magnetic stimulation to elicit responses from pharyngeal and submental muscles
- A study using near infrared spectroscopy to examine brain activation responses to sensory stimulation, brain laterality for swallowing and the effects of transcranial direct current stimulation (tDCS) on brain responses to sensory stimulation and brain activation for swallowing.
Patients with chronic pharyngeal dysphagia following brain injury will participate in a clinical trial evaluating swallowing motor retraining with and without sensory stimulation. This study will be a randomized, blinded Phase 2 clinical trial in which patients will be assigned to two training conditions: training with sham sensory stimulation and training with vibrotactile sensory stimulation.
A non-invasive, external vibrotactile stimulator on the throat will provide external sensory stimulation. Pre-training testing, training sessions, and post-training testing will be provided in up to 20 visits for each subject.
Outcome Measures:
The primary outcome variables will be measures of swallowing function before and after training and at 3 and 6 months post training. These will include the NIH Swallowing Safety Scale scored from masked videofluoroscopy recordings and the Water Test, a non-invasive assessment of swallowing. Both will be scored by speech pathologists blinded to patient training group identity or condition before or after training.
To assess the relationship of improvements in training with changes in neuronal function, transcranial magnetic stimulation with surface electromyography recordings will be used to assess changes in corticobulbar conduction following training.
To assess whether functional activation within the brain (particularly in the region of M1) is related to improvement in swallowing following each type of training, near infrared spectroscopy NIRS will be used to examine blood oxygenation level dependent changes in brain function for swallowing following training. All outcome measures will be scored without knowledge of training group or condition (pre vs. post training or training group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Button Press | Other | Procedure: Swallowing TrainingTraining with button press |
| Vibtrotactile | Other | Procedure: Swallowing TrainingSensory Stimulation - Vibrotactile device with button press to initiate swallowing during retraining |
| Cortical Stimulation | Other | Procedure: Swallowing TrainingTraining with Cortical stimulation - cortical stimulation during training with button press |
| Combined | Other | Procedure: Swallowing TrainingCombined vibrotactile and cortical stimulation with button press training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusive ages of 18 to 75
- The healthy volunteers will be without cardiac, neurological, psychiatric, speech or swallowing problems as determined by medical history and examination by a physician
Key exclusion criteria (10 listed)
- History of epileptic seizure
- History of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) or a cardiac pacemaker in place
- History of past brain injury or neurological disorders
- Currently on medications for a psychiatric disorder
- Presence of progressive neurodegenerative disorders, such as dementia, Parkinson's Disease, multiple sclerosis, peripheral neuropathy, and amyotrophic lateral sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowing TrainingSwallowing Training with press of button | Procedure or surgery | Button Press, Combined, Cortical Stimulation, Vibtrotactile |
Primary outcome
Swallowing safety
Time frame: Immediately following training
1 secondary outcome
SWAL_QUAL Patient questionnaire
Time frame: Immediately following training and 3 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 14669519Adkins-Muir DL, Jones TA. Cortical electrical stimulation combined with rehabilitative training: enhanced functional recovery and dendritic plasticity following focal cortical ischemia in rats. Neurol Res. 2003 Dec;25(8):780-8. doi: 10.1179/016164103771953853.
- Background: PubMed 2226363Agnew WF, McCreery DB. Considerations for safety with chronically implanted nerve electrodes. Epilepsia. 1990;31 Suppl 2:S27-32. doi: 10.1111/j.1528-1157.1990.tb05845.x.
- Background: PubMed 11546900Aydogdu I, Ertekin C, Tarlaci S, Turman B, Kiylioglu N, Secil Y. Dysphagia in lateral medullary infarction (Wallenberg's syndrome): an acute disconnection syndrome in premotor neurons related to swallowing activity? Stroke. 2001 Sep;32(9):2081-7. doi: 10.1161/hs0901.094278.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Swallowing Training in people with Stroke and Dysphagia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing safety (time frame: Immediately following training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00306501, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.