A Study of tDCS for Swallowing Difficulties in Stroke Patients

Pusan National University

Status: Unknown

Conditions: Stroke

Treatments: Device: Sham Eldith DC-STIMULATOR; Device: Eldith DC-STIMULATOR

Study type: Interventional

Funder types: Other

Identifiers

NCT02422225

PNUYH-03-2015-004

Details and patient eligibility

About

The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.

Full description

120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis
• Subjects who have cortical or subcortical brain lesion
• Subjects who was diagnosed as stroke within 6 months
• Subjects ages from 18years to 80years old
• Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury
• Subjects who is possible to receive swallowing function intervention 5 days a week
• Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver
• Subjects who had no effect from brain stimulation or electrical stimulation therapy

Exclusion Criteria

• Subjects who have pre-existing and active major neurological disease
• Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
• Subjects who have brain lesion except cortex or subcortex area
• Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure
• Subjects who is estimated as not appropriate for the study by the investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Eldith DC-STIMULATOR group

Experimental group

Description:

Intervention: 20-minutes of transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (30 applications for each 3 groups: total 90 applications)

Treatment:

Device: Eldith DC-STIMULATOR

sham-Eldith DC-STIMULATOR group

Sham Comparator group

Description:

Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)

Treatment:

Device: Sham Eldith DC-STIMULATOR