StrokeNCT02506075
A Study of tDCS for Unilateral Neglect in Stroke Patients
A study testing Transcranical direct current stimulator and Visual inattention training in people with Stroke, run by Pusan National University at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranical direct current stimulator and Visual inattention training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 626-770
Yong-Il Shin, Ph.D., 82-55-360-2872, rmshin01@gmail.com
Min Su Park, MS, 82-55-360-4154, minsu.park.otr@gmail.com
About this study
Official title: Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke
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
Read the 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.
- Conditions
- Stroke
- Being tested
- Transcranical direct current stimulator, Visual inattention training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranical direct current stimulatorDevice
approved by Conformity European as safe treatment device for stroke patients
Visual inattention trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranical direct current stimulator; Behavioral: Visual inattention training |
| Simultaneous tDCS group | Experimental | In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously. Receives: Device: Transcranical direct current stimulator; Behavioral: Visual inattention training |
| Sham control group | No intervention | without transcranical direct current stimulator(tDCS) or without visual training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inattention Test
Line bisection test
Measured: up to 2 min
Behavioral Inattention Test
Letter cancellation test
Measured: up to 2 min
Secondary outcomes (3)
Behavioral Inattention Test
Line bisection test
Measured: 60 min, 120 min, 24 hrs after intervention
Behavioral Inattention Test
Letter cancellation test
Measured: 60 min, 120 min, 24 hrs after intervention
ADL assssement
Catherine Bergego Scale
Measured: 60 min, 120 min, 24 hrs after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Medwill hospital
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University
- Investigators
- Yong-Il Shin, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506075
- Sponsor's protocol ID
- PNUYH-03-2015-005
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14669519
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke
- ClinicalTrials.gov ID
- NCT02506075
- Acronym / sponsor ID
- PNUYH-03-2015-005
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Medwill hospital
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-tDCS group | Experimental | Device: Transcranical direct current stimulator, Behavioral: Visual inattention trainingIn 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. |
| Simultaneous tDCS group | Experimental | Device: Transcranical direct current stimulator, Behavioral: Visual inattention trainingIn Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously. |
| Sham control group | No intervention | –without transcranical direct current stimulator(tDCS) or without visual training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranical direct current stimulatorapproved by Conformity European as safe treatment device for stroke patients | Device | Pre-tDCS group, Simultaneous tDCS group |
| Visual inattention training | Behavioural | Pre-tDCS group, Simultaneous tDCS group |
Primary outcome
Behavioral Inattention Test
Time frame: up to 2 min
Line bisection test
Behavioral Inattention Test
Time frame: up to 2 min
Letter cancellation test
3 secondary outcomes
Behavioral Inattention Test
Time frame: 60 min, 120 min, 24 hrs after intervention
Behavioral Inattention Test
Time frame: 60 min, 120 min, 24 hrs after intervention
ADL assssement
Time frame: 60 min, 120 min, 24 hrs after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Background: PubMed 14669519Adkins-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.
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-Il Shin principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranical direct current stimulator and Visual inattention training in people with Stroke, run by Pusan National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Il Shin, Ph.D. (82-55-360-2872, rmshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Inattention Test (time frame: up to 2 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.