A Study of tDCS for Unilateral Neglect in Stroke Patients

Stroke Clinical Trial

Official title:

Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506075
• Other study ID #: PNUYH-03-2015-005
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 21, 2015
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Pusan National University School of Medicine
• Contact: Yong-Il Shin, Ph.D.
• Phone: 82-55-360-2872
• Email: rmshin[@]gmail.com
• 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 confirm and compare the effect of methods of transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients

Description:

Total 105 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into two types; Pre-tDCS group and Simultaneous tDCS group. Two groups are again divided into three groups; Dual stimulation group, Unilateral stimulation group and Sham control group, respectively.

In Pre-tDCS group, total a sessions of the tDCS stimulation was done for each three subgroups and visual inattention training was followed after that. In Simultaneous tDCS group, tDCS and visual inattention training was done simultaneously. For each subgroups, tDCS was attached at following locations; unilateral cathodal tDCS on unaffected PPC(postparietal cortex), P3 , dual cathodal tDCS on P3 and anodal tDCS on affected PPC, P4.

The patients were initially evaluated at baseline, immediately, 60min, 120min, 24 hrs after the training session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• 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 ages older than 18years old

• Subjects who have 19 of K-MMSE score

• Subjects who has unilateral neglect with BIT-C less than 129

• 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

• Subjects whose dominant side are confirm by Edinburgh Handedness Inventory

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:
• Transcranical direct current stimulator
approved by Conformity European as safe treatment device for stroke patients

Behavioral:
• Visual inattention training

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University School of Medicine	Medwill hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Adkins-Muir DL, Jones TA. Cortical electrical stimulation combined with rehabilitative training: enhanced functional recovery and dendritic plasticity following focal cortical ischemia in rats. Neurol Res. 2003 Dec;25(8):780-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Inattention Test	Line bisection test	up to 2 min	No
Primary	Behavioral Inattention Test	Letter cancellation test	up to 2 min	No
Secondary	Behavioral Inattention Test	Line bisection test	60 min, 120 min, 24 hrs after intervention	No
Secondary	Behavioral Inattention Test	Letter cancellation test	60 min, 120 min, 24 hrs after intervention	No
Secondary	ADL assssement	Catherine Bergego Scale	60 min, 120 min, 24 hrs after intervention	No