A Study of tDCS for Swallowing Difficulties in Stroke Patients

NCT ID: NCT02422225

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eldith DC-STIMULATOR group

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)

Group Type: EXPERIMENTAL

Eldith DC-STIMULATOR

Intervention Type: DEVICE

Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients

tDCS intervention]

• Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany
• Stimulation site <Experimental group>

• Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit
• Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex
• Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit <Control group> Sham stimulation

sham-Eldith DC-STIMULATOR group

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

Group Type: SHAM_COMPARATOR

Sham Eldith DC-STIMULATOR

Intervention Type: DEVICE

Interventions

Eldith DC-STIMULATOR

Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients

tDCS intervention]

• Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany
• Stimulation site <Experimental group>

• Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit
• Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex
• Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit <Control group> Sham stimulation

Intervention Type: DEVICE

Sham Eldith DC-STIMULATOR

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong-Il Shin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Yong Il Shin, MD.PhD

Role: primary

rmshin01@gmail.com

82-55-360-2872 ext. 82-55-360-2872

References

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.

Reference Type: BACKGROUND

PMID: 20407308 (View on PubMed)

Other Identifiers

PNUYH-03-2015-004

Identifier Type: -

Identifier Source: org_study_id