N/A
N=42
Fostering Eating After Stroke With Transcranial Direct Current Stimulation
Dysphagia · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01919112 ↗Enrolled (actual)
42
Serious AEs
9.5%
Results posted
Jul 2020
Primary outcome: Primary: To Assess Changes in Penetration and Aspiration — -0.4; -0.8; -0.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tDCS (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess Changes in Penetration and Aspiration |
-0.4; -0.8; -0.8 | — |
| PRIMARY To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups |
0; 0; 0 | — |
| PRIMARY 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 |
0; 0; 0 | — |
| PRIMARY To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups |
0; 0; 0 | — |
| PRIMARY To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups |
0; 0; 0 | — |
| PRIMARY To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups |
0; 0; 0 | — |
| SECONDARY To Assess and Compare Changes in Dietary Intake in Each of the Three Groups |
2.9; 2.5; 2.1 | — |
| SECONDARY To Assess Changes in Physiological Measures of Pharyngeal Strength |
-0.01; -0.1; -0.02 | — |
| SECONDARY To Assess Changes in Physiological Measures of Briskness of Swallow Onset |
5.2; -7.3; 0.83 | — |
| SECONDARY To Assess Changes in Physiological Measures of Laryngeal Excursion |
0.07; 0.17; 0.14 | — |
| SECONDARY Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment |
-0.34; -0.81; -0.96 | 0.116 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01919112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.