A Study of tDCS for Swallowing Difficulties in Stroke Patients

Stroke Clinical Trial

Official title:

Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02422225
• Other study ID #: PNUYH-03-2015-004
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2015
• Last updated: July 20, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Pusan National University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Education, Science, and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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
• Sham Eldith DC-STIMULATOR

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)		up to 60 sec	No
Secondary	American Speech-LanguageHearing Association(ASHA)-Norms	Change in swallowing function	up to 2 weeks after tDCS	No
Secondary	Korean Version of Modified Barthel Index(K-MBI)	Change in activity of daily living	up to 2 weeks after tDCS	No
Secondary	Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing	Change in swallowing function	2 weeks after tDCS	No