Fostering Eating After Stroke With Transcranial Direct Current Stimulation

NCT01919112 | Completed Results DMC

• 2 other identifiers: 2013P0000671R01DC012584-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Stroke

Keywords

Brain stimulation

Outcome Measures

Primary Outcomes (6)

• To Assess Changes in Penetration and Aspiration

  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.

  Scores will be measured before tDCS and after 5 days after completion of stimulation

• To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups

  We will tabulate the number of participants who develop seizures in the High-dose anodal tDCS, Low-dose anodal tDCS and Sham stimulation groups.

  During the 5 days of stimulation sessions

• 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

  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.

  During the 5 days of stimulation sessions

• To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups

  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.

  During the 5 days of stimulation sessions

• To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups

  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.

  During the 5 days of stimulation sessions

• To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups

  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.

  Any change between day 1 and day 3 of stimulation session

Secondary Outcomes (5)

• To Assess and Compare Changes in Dietary Intake in Each of the Three Groups

  At study onset and after 1 month

• To Assess Changes in Physiological Measures of Pharyngeal Strength

  Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation

• To Assess Changes in Physiological Measures of Briskness of Swallow Onset

  Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation

• To Assess Changes in Physiological Measures of Laryngeal Excursion

  Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation

• Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment

  At day 5 of study participation

Study Arms (3)

High dose anodal tDCS

EXPERIMENTAL

High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises

Device: tDCS

Low dose anodal tDCS

ACTIVE COMPARATOR

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

Sham Stimulation

SHAM COMPARATOR

Twice daily swallowing exercises only

Device: tDCS

Interventions

tDCS DEVICE

Anodal tDCS will be administered with swallowing exercises

High dose anodal tDCS; Low dose anodal tDCS; Sham Stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 25534369 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Sandeep Kumar, MD
• Organization: Beth Israel Deaconess Medical Center

skumar@bidmc.harvard.edu

617-632-8917

Study Officials

• Sandeep Kumar, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: September 1, 2013
• Primary Completion: May 31, 2019
• Study Completion: September 1, 2019
• Last Updated: July 21, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-07

Locations

US (1)