Clinical trial NCT02506075: A Study of tDCS for Unilateral Neglect in Stroke Patients
Official title: Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Medwill hospital
First posted: 2015-07-22
Enrollment: 105
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 confirm and compare the effect of methods of transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients

Detailed 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.

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 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

Primary outcomes:
measure: Behavioral Inattention Test
timeFrame: up to 2 min
measure: Behavioral Inattention Test
timeFrame: up to 2 min
Secondary outcomes:
measure: Behavioral Inattention Test
timeFrame: 60 min, 120 min, 24 hrs after intervention
measure: Behavioral Inattention Test
timeFrame: 60 min, 120 min, 24 hrs after intervention
measure: ADL assssement
timeFrame: 60 min, 120 min, 24 hrs after intervention
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
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1179/016164103771953853.