A Study of tDCS for Unilateral Neglect in Stroke Patients

NCT ID: NCT02506075

Last Updated: 2015-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-tDCS group

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.

Group Type EXPERIMENTAL

Transcranical direct current stimulator

Intervention Type DEVICE

approved by Conformity European as safe treatment device for stroke patients

Visual inattention training

Intervention Type BEHAVIORAL

Simultaneous tDCS group

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

Group Type EXPERIMENTAL

Transcranical direct current stimulator

Intervention Type DEVICE

approved by Conformity European as safe treatment device for stroke patients

Visual inattention training

Intervention Type BEHAVIORAL

Sham control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranical direct current stimulator

approved by Conformity European as safe treatment device for stroke patients

Intervention Type DEVICE

Visual inattention training

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medwill hospital

UNKNOWN

Sponsor Role collaborator

Pusan National University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yong-il Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yong-Il Shin

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yong-Il Shin, Ph.D.

Role: CONTACT

82-55-360-2872

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yong-Il Shin, Ph.D.

Role: primary

82-55-360-2872

Min Su Park, MS

Role: backup

82-55-360-4154

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14669519 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PNUYH-03-2015-005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of tDCS on Cognition in MCI: A RCT
NCT05584748 NOT_YET_RECRUITING NA
Cognitive Stimulation Study
NCT02067689 COMPLETED NA