Clinical trial NCT02422225: A Study of tDCS for Swallowing Difficulties in Stroke Patients
Official title: Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Pusan National University
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
timeFrame: up to 60 sec
Secondary outcomes:
measure: American Speech-LanguageHearing Association(ASHA)-Norms
timeFrame: up to 2 weeks after tDCS
measure: Korean Version of Modified Barthel Index(K-MBI)
timeFrame: up to 2 weeks after tDCS
measure: Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing
timeFrame: 2 weeks after tDCS
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-Il Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2.