- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919112
Fostering Eating After Stroke With Transcranial Direct Current Stimulation (FEASt)
Non-invasive Brain Stimulation for Swallowing Recovery After a Dysphagic Stroke
Swallowing difficulties are common after a stroke and can lead to serious complications like pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving swallowing in stroke patients.
Previous investigations have shown that recovery of swallowing functions occurs from reorganization ("rewiring") of the non-involved cerebral hemisphere. In this study, the investigators propose to investigate a new intervention, which combines, swallowing exercises with brain stimulation targeted to the non-involved cerebral hemisphere, using low intensity current in acute stroke patients. The investigators plan to assess the safety of this technique in this patient population and also assess its effect on improving swallowing functions and swallowing physiology. During this time trial participants will undergo standardized swallowing and neurological assessments as well as brain MRI scans.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 21 years or older in age since safety of non-invasive cortical stimulation in children.
- Between 25 hours (day 2) to 144 (day 6) hours since stroke onset.
- Unilateral hemispheric infarction (cortical or subcortical infarction) documented by imaging.
- Moderate to severe dysphagia with a score of 4 or more on Penetration and Aspiration Scale (PAS)
Exclusion Criteria:
- Prior history of swallowing difficulties.
- Drowsiness or marked cognitive impairment that interferes with participation in swallowing maneuvers.
- Unable to undergo an MRI due to claustrophobia or presence of electrically, magnetically or mechanically activated implant (including cardiac pacemaker), intracerebral vascular clips or any other electrically sensitive support system, metal in any part of the body, including metallic injury to eye, or pregnancy).
- History of seizures or unexplained episodes of loss of consciousness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High dose anodal tDCS
High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises
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Anodal tDCS will be administered with swallowing exercises
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Active Comparator: Low dose anodal tDCS
This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises
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Anodal tDCS will be administered with swallowing exercises
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Sham Comparator: Sham Stimulation
Twice daily swallowing exercises only
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Anodal tDCS will be administered with swallowing exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Assess Changes in Penetration and Aspiration
Time Frame: Scores will be measured before tDCS and after 5 days after completion of stimulation
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This will be assessed using the Penetration and Aspiration Scale (PAS) scores, a validated 8 point ordinal scale that quantifies penetration and aspiration events observed during Videofluoroscopic Swallowing Evaluation.
PAS ranges from 1 (best score) representing no aspiration or penetration to 8 (worst score) representing severe aspiration.
An average PAS score will be computed based on 9 swallows for this outcome.
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Scores will be measured before tDCS and after 5 days after completion of stimulation
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To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups
Time Frame: During the 5 days of stimulation sessions
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We will tabulate the number of participants who develop seizures in the High-dose anodal tDCS, Low-dose anodal tDCS and Sham stimulation groups.
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During the 5 days of stimulation sessions
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To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Deaths in Each of the 3 Groups Attributable to the Direct Effects of Stroke
Time Frame: During the 5 days of stimulation sessions
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We will tabulate the number of deaths in High-dose tDCS, Low-dose tDCS and Sham stimulation groups, that are attributable to the direct effects of the qualifying stroke.
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During the 5 days of stimulation sessions
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To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups
Time Frame: During the 5 days of stimulation sessions
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We will tabulate the number of participants who develop neurological deterioration in the High-dose tDCS, Low-dose tDCS and Sham groups.
Neurological deterioration will be defined as an increase in the total National Institute of Health Stroke Scale (NIHSS) Score by 4 or more points between each successive day.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss.
NIHSS ranges from 0 (normal) to 42 (worst possible score).
Higher scores mean worse neurological functions.
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During the 5 days of stimulation sessions
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To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups
Time Frame: During the 5 days of stimulation sessions
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We will tabulate the number of participants with deterioration in their motor functions in the High-dose tDCS, Low-dose tDCS and Sham groups.
Motor deterioration will be defined as an increase in the motor sub-item of the National Institute of Health Stroke Scale (NIHSS) score by 2 or more points between each successive day of stimulation.
The motor sub-item of the NIHSS ranges from 0 (normal) to 16 (worst possible score), with higher scores indicating a worse motor exam.
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During the 5 days of stimulation sessions
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To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups
Time Frame: Any change between day 1 and day 3 of stimulation session
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We will tabulate the number of participants with swallowing deterioration in the High-dose tDCS, Low-dose tDCS and sham groups Swallowing deterioration will be defined as an increase in the score by 2 or more points in the Functional Oral Intake Scale (FOIS).
FOIS provides a validated measure of diet level.
FOIS is an ordinal scale ranging from 7 (normal diet) to 0 (no oral intake), with lower scores indicating a worse diet.
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Any change between day 1 and day 3 of stimulation session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Assess and Compare Changes in Dietary Intake in Each of the Three Groups
Time Frame: At study onset and after 1 month
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The durability of any observed effects of the intervention on dietary status will be estimated by changes in Functional Oral Intake Scale (FOIS) score.
FOIS is an ordinal scale ranging from 1 (worst) to 7 (normal oral diet) and provides a reliable measure of dietary intake.
The change in FOIS scores across each group will be compared.
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At study onset and after 1 month
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To Assess Changes in Physiological Measures of Pharyngeal Strength
Time Frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
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Examining effects of differing doses of anodal tDCS versus sham stimulation on Pharyngeal Constriction Ratio (PCR), derived from videofluoroscopic swallowing studies.PCR is a measure of the pharyngeal area visible in the lateral radiograph view at the point when a bolus is held in the oral cavity divided by the pharyngeal area at the point of maximum pharyngeal constriction during the swallow.
A higher PCR indicates a weak swallow leading to increased food residue in the pharynx.
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Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
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To Assess Changes in Physiological Measures of Briskness of Swallow Onset
Time Frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
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Examining effects of differing doses of anodal tDCS versus sham stimulation on Pharyngeal Delay Time (PDT) , derived from videofluoroscopic swallowing studies.
PDT is defined as the time in centiseconds that the bolus is present in the hypopharynx before the swallow is triggered.
PDT is a temporal measure of the briskness of the swallow onset.
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Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
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To Assess Changes in Physiological Measures of Laryngeal Excursion
Time Frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
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Examining effects of differing doses of anodal tDCS versus sham stimulation on measure of actual excursion of the larynx in centimeters from their resting point to maximal excursion, derived from videofluoroscopic swallowing studies.
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Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
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Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment
Time Frame: At day 5 of study participation
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We will examine the effects of the intervention in a linear model by using it as a predictor for dysphagia recovery along with other variables of interest [age, baseline National Institute of Health Stroke Scale and Penetration and Aspiration Scale (PAS) scores], with a change in PAS scores from baseline to day 5 of the intervention, as being the outcome of interest.
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At day 5 of study participation
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P000067
- 1R01DC012584-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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