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Fostering Eating After Stroke With Transcranial Direct Current Stimulation (FEASt)

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ClinicalTrials.gov Identifier: NCT01919112
Recruitment Status : Active, not recruiting
First Posted : August 8, 2013
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Sandeep Kumar, Beth Israel Deaconess Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dysphagia Stroke Device: tDCS Not Applicable

Detailed Description:
Swallowing impairments are a common and a serious complication of stroke but lack effective therapies. The study investigators herein propose to conduct a prospective clinical study using a non-invasive brain stimulation technique, anodal transcranial direct current stimulation (tDCS), in combination with swallowing exercises for improving dysphagia due to an acute-subacute hemispheric infarction, and obtain data on safety and effect of 2 different doses of tDCS, on swallowing physiology and behavior. Dysphagia from hemispheric strokes occurs due to disruption of the cortical projections to the brainstem swallowing centers while recovery of swallowing functions have been shown to be mediated via the reorganization of the swallowing cortex in the unaffected hemisphere. A recent pilot study conducted by the investigators demonstrated the safety and feasibility of applying 5 consecutive daily sessions of anodal tDCS for 30 minutes to the swallowing cortex on the unaffected hemisphere in the acute-subacute stroke phases and showed a promise in improving dysphagia, when combined with swallowing exercises. The proposed research will be used to further confirm safety of this technique in early stroke phases and explore alternative, more effective doses for promoting swallowing recovery prior to its examination in any confirmatory trials. The investigators will use the study cohort to examine important subject specific parameters which influence response to the proposed intervention in dysphagic stroke patients. The overall aim of this study is to gather additional safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiological and clinically relevant swallowing parameters, examine possible dose effects, and identify candidates who are more likely to benefit from this intervention. The experience gained from this project will guide planning of future confirmatory trials that use relevant clinical outcomes to assess potential benefits of this intervention and utilize important subject specific parameters to refine study inclusion criteria and aid in severity adjusted analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial will randomize subjects to anodal transcranial direct current stimulation (tDCS) versus sham stimulation, both of them carried out in combination with standardized swallowing exercises
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigators and subjects will be masked to the trail arm assignments at randomization. The investigator reviewing outcome data will also be masked to the trial assignments.
Primary Purpose: Treatment
Official Title: Non-invasive Brain Stimulation for Swallowing Recovery After a Dysphagic Stroke
Actual Study Start Date : September 2013
Actual Primary Completion Date : May 31, 2019
Estimated Study Completion Date : August 2019

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
Device: tDCS
Anodal tDCS will be administered with swallowing exercises

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
Device: tDCS
Anodal tDCS will be administered with swallowing exercises

Sham Comparator: Sham Stimulation
Twice daily swallowing exercises only
Device: tDCS
Anodal tDCS will be administered with swallowing exercises




Primary Outcome Measures :
  1. To assess changes in penetration and aspiration [ Time Frame: Scores will be measured before tDCS and after 5 days after completion of stimulation ]
    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.

  2. To Assess safety of tDCS in acute-subacute stroke phase: incidence of seizures in each of the 3 groups [ Time Frame: During the 5 days of stimulation sessions ]
    To compare the anticipated and observed incidence of seizures in each of the 3 groups.

  3. To Assess safety of tDCS in acute-subacute stroke phase: incidence of stroke specific mortality in each of the 3 groups [ Time Frame: During the 5 days of stimulation sessions ]
    To compare the anticipated and observed incidence of stroke specific mortality in each of the 3 groups.

  4. To Assess safety of tDCS in acute-subacute stroke phase: incidence of neurological deterioration in each of the 3 groups [ Time Frame: During the 5 days of stimulation sessions ]
    To compare the anticipated and observed incidence of neurological deterioration in each of the 3 groups. Neurological deterioration will be defined as an increase in the total NIH Stroke Scale 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).

  5. To Assess safety of tDCS in acute-subacute stroke phase: incidence of motor deterioration in each of the 3 groups [ Time Frame: During the 5 days of stimulation sessions ]
    To compare the anticipated and observed incidence of motor deterioration in each of the 3 groups. Motor deterioration will be defined as an increase in the score by 2 or more points in the motor sub-item of the NIHSS between each successive day. The motor sub-item of the NIHSS ranges from 0 (normal) to 16 (worst possible score).

  6. To Assess safety of tDCS in acute-subacute stroke phase: incidence of swallowing deterioration in each of the 3 groups [ Time Frame: Any change between day 1 and day 3 of stimulation session ]
    To compare the anticipated and observed incidence of swallowing deterioration in each of the 3 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).


Secondary Outcome Measures :
  1. To assess changes in dietary intake [ Time Frame: FOIS score will be computed at study onset and after 1 month ]
    Examining durability of any observed effects of tDCS on dietary status as determined 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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. To assess changes in physiological measures of hyolaryngeal excursion [ Time Frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation ]
    Examining effects of differing doses of anodal tDCS versus sham stimulation on measure of actual excursion of the hyoid, larynx and pharynx in centimeters from their resting point to maximal excursion, derived from videofluoroscopic swallowing studies.

  5. To investigate the impact of subject-specific predictors of dysphagia recovery on the outcome of the investigator's proposed intervention. [ Time Frame: At day 5 of study participation ]
    To assess the effect size across subject-specific predictors (baseline NIHSS score, dysarthria, CBT-lesion load and intubation), subgroup analyses will be conducted. For such analysis regression models will be employed that include intervention, covariate and covariate by treatment interactions as predictors and PAS scores as outcomes, to examine the modifying effect of the covariates on the intervention. If a significant interaction is detected, analyses of major efficacy endpoints (PAS scores) will be performed within each group.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919112


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Sandeep Kumar, MD Beth Israel Deaconess Medical Center

Publications:
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Responsible Party: Sandeep Kumar, Associate Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01919112     History of Changes
Other Study ID Numbers: 2013P000067
1R01DC012584-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by Sandeep Kumar, Beth Israel Deaconess Medical Center:
Brain stimulation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases