NCT02506075

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

July 21, 2015

Last Update Submit

July 21, 2015

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Behavioral Inattention Test

    Line bisection test

    up to 2 min

  • Behavioral Inattention Test

    Letter cancellation test

    up to 2 min

Secondary Outcomes (3)

  • Behavioral Inattention Test

    60 min, 120 min, 24 hrs after intervention

  • Behavioral Inattention Test

    60 min, 120 min, 24 hrs after intervention

  • ADL assssement

    60 min, 120 min, 24 hrs after intervention

Study Arms (3)

Pre-tDCS group

EXPERIMENTAL

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.

Device: Transcranical direct current stimulatorBehavioral: Visual inattention training

Simultaneous tDCS group

EXPERIMENTAL

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

Device: Transcranical direct current stimulatorBehavioral: Visual inattention training

Sham control group

NO INTERVENTION

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

Interventions

Transcranical direct current stimulatorDEVICE

approved by Conformity European as safe treatment device for stroke patients

Pre-tDCS groupSimultaneous tDCS group
Visual inattention trainingBEHAVIORAL
Pre-tDCS groupSimultaneous tDCS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

RECRUITING

Related 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. doi: 10.1179/016164103771953853.

    PMID: 14669519BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yong-Il Shin

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Il Shin, Ph.D.

CONTACT

82-55-360-2872rmshin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 22, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

KR(1)