Mild Cognitive ImpairmentNCT02320890
Study of tDCS for Mild Cognitive Impairment
A study testing YBand (YDT-201N) in people with Mild Cognitive Impairment, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
The primary objective of this study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI) Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- YBand (YDT-201N)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Oct 2015
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects who have a subjective memory impairment
- Subjects who have Korean version of Mini Mental Status Examination score 22 or more
- Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
- Subjects who have had other cognitive impairments besides memory
- Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
- Subjects who are not dementia of Alzheimer's type
Show all 9Show fewer
- Subjects who are right-handed
- Subjects who are able to read and write
- Subject or legally responsible caregiver has provided informed consent
Who cannot join
- Subjects who have a history of stroke and seizures
- Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a treatment ischemic attack.
- Subjects who have neurologic problems on physical examination that cuase memory disturbances
- Subjects who have a history of DSM-IV Axis I disorders
- Subjects who have extremely sensitive skin
- Subjects who have suffered from the cancer in 3 years
Show all 15Show fewer
- Subjects who have had a cerebrovascular neurosurgery in medical history
- Subjects who have dyspnea in sitting position
- Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack.
- Subjects who have a history of drug or alcohol abuse (in the past 5 years)
- Subjects who have a history of mental or emotional disorders (in the past 5 years)
- Subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia
- Subjects who have a history of hospitalization due to head injury
- Subjects who are unable to read even with glasses
- Subject who are unable to understand the conversation due to the hearing defect (even with the hearing aid)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study for the Short- and Long-term Improvement of Cognitive Function (Evaluated by PET-CT and SNSB) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment
The primary objective of this study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)
Read the detailed description
Twenty-four patients were recruited and randomized to receive either real- or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. The patients were evaluated at baseline and at Week 12.
- Conditions
- Mild Cognitive Impairment
- Being tested
- YBand (YDT-201N), sham-YBand (YDT-201N)
- Keywords
- transcranial direct current stimulation, tDCS, Mild Cognitive Impairment, MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YBand (YDT-201N)Device
transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left(anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
sham-YBand (YDT-201N)Device
transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| YBand (YDT-201N) | Experimental | transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 applications) Receives: Device: YBand (YDT-201N) |
| sham-Yband (YDT-201N) | Sham comparator | sham-tDCS application 3 days a week for 12 weeks (total of 36 applications) Receives: Device: sham-YBand (YDT-201N) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PET-CT images
Measured: from baseline to Week 12
Secondary outcomes (4)
Change in Cognitive function
Measured by SNSB
Measured: from baseline to Week 12
Change in Cognitive function
Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR)
Measured: from baseline to Week 12
Change in activities of daily living
Measured by B-ADL
Measured: from baseline to Week 12
Change in Geriatric Depression Scale
Measured: from baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Principal investigator, Yong An Chung, Incheon St.Mary's Hospital
- Investigators
- Yong-An Chung, M.D., Ph.D., Principal investigator, Professor, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320890
- Sponsor's protocol ID
- OC14OISI0045
- Status last verified
- Aug 2018
- First submitted
- 16 Dec 2014
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Short- and Long-term Improvement of Cognitive Function (Evaluated by PET-CT and SNSB) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02320890
- Acronym / sponsor ID
- OC14OISI0045
- Conditions
- Mild Cognitive Impairment
- Keywords
- transcranial direct current stimulation, tDCS, Mild Cognitive Impairment, MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Dec 2014 (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 investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)
Detailed description
Twenty-four patients were recruited and randomized to receive either real- or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. The patients were evaluated at baseline and at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YBand (YDT-201N) | Experimental | Device: YBand (YDT-201N)transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 applications) |
| sham-Yband (YDT-201N) | Sham comparator | Device: sham-YBand (YDT-201N)sham-tDCS application 3 days a week for 12 weeks (total of 36 applications) |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Subjects who have a subjective memory impairment
- Subjects who have Korean version of Mini Mental Status Examination score 22 or more
- Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
- Subjects who have had other cognitive impairments besides memory
- Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
Key exclusion criteria (15 listed)
- Subjects who have a history of stroke and seizures
- Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a treatment ischemic attack.
- Subjects who have neurologic problems on physical examination that cuase memory disturbances
- Subjects who have a history of DSM-IV Axis I disorders
- Subjects who have extremely sensitive skin
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 |
|---|---|---|
| YBand (YDT-201N)transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left(anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | YBand (YDT-201N) |
| sham-YBand (YDT-201N)transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | sham-Yband (YDT-201N) |
Primary outcome
Change in PET-CT images
Time frame: from baseline to Week 12
4 secondary outcomes
Change in Cognitive function
Time frame: from baseline to Week 12
Change in Cognitive function
Time frame: from baseline to Week 12
Change in activities of daily living
Time frame: from baseline to Week 12
Change in Geriatric Depression Scale
Time frame: from baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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-An Chung, M.D., Ph.D. principal investigator
Professor, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YBand (YDT-201N) in people with Mild Cognitive Impairment, run by Incheon St.Mary's Hospital 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 8 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PET-CT images (time frame: from baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2018.