Clinical trial NCT01919112: Fostering Eating After Stroke With Transcranial Direct Current Stimulation
Official title: Non-invasive Brain Stimulation for Swallowing Recovery After a Dysphagic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Stroke
Keywords: Brain stimulation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-08-08
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Eligibility 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 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.

Primary outcomes:
measure: To Assess Changes in Penetration and Aspiration
timeFrame: Scores will be measured before tDCS and after 5 days after completion of stimulation
measure: To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups
timeFrame: During the 5 days of stimulation sessions
measure: 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
timeFrame: During the 5 days of stimulation sessions
measure: To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups
timeFrame: During the 5 days of stimulation sessions
measure: To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups
timeFrame: During the 5 days of stimulation sessions
measure: To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups
timeFrame: Any change between day 1 and day 3 of stimulation session
Secondary outcomes:
measure: To Assess and Compare Changes in Dietary Intake in Each of the Three Groups
timeFrame: At study onset and after 1 month
measure: To Assess Changes in Physiological Measures of Pharyngeal Strength
timeFrame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
measure: To Assess Changes in Physiological Measures of Briskness of Swallow Onset
timeFrame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
measure: To Assess Changes in Physiological Measures of Laryngeal Excursion
timeFrame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
measure: Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment
timeFrame: At day 5 of study participation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Sandeep Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marchina S, Schlaug G, Kumar S. Study design for the fostering eating after stroke with transcranial direct current stimulation trial: a randomized controlled intervention for improving Dysphagia after acute ischemic stroke. J Stroke Cerebrovasc Dis. 2015 Mar;24(3):511-20. doi: 10.1016/j.jstrokecerebrovasdis.2014.09.027. Epub 2014 Dec 19.