A Study of tDCS for Unilateral Neglect in Stroke Patients

Pusan National University

Status: Unknown

Conditions: Stroke

Treatments: Device: Transcranical direct current stimulator; Behavioral: Visual inattention training

Study type: Interventional

Funder types: Other

Identifiers

NCT02506075

PNUYH-03-2015-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

105 participants in 3 patient groups

Pre-tDCS group

Experimental group

Description:

In Pre-tDCS group, total sessions of the transcranical direct current stimulator stimulation(tDCS) was done for each three subgroups and visual inattention training was followed after that. Patient had 2 times of tDCS for 13 minutes with 20minutes of resting interval. After that, additional 2 times of Visual inattention training was done with same protocol.

Treatment:

Behavioral: Visual inattention training

Device: Transcranical direct current stimulator

Simultaneous tDCS group

Experimental group

Description:

In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.

Treatment:

Behavioral: Visual inattention training

Device: Transcranical direct current stimulator

Sham control group

No Intervention group

Description:

without transcranical direct current stimulator(tDCS) or without visual training