Mild Cognitive ImpairmentNCT02227966
A Pilot Study of tDCS for Mild Cognitive Impairment
A study testing Yband (YDT-201N) in people with Mild Cognitive Impairment, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The primary objective of this preliminary 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 80 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
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Dec 2014
- 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 80 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 24 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 with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem
- Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
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- Subjects who are right-handed
- Subjects who are able to read and write
- Both subject and legally responsible caregiver have provided informed consent
- According to the latest MRI result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm
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 transient ischemic attack.
- Subjects who have neurologic problems on physical examination that cause 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
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- 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
- Subjects 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.
South Korea1 site
Samsung Medical Center
Seoul, 135-710
Duk L Na, MD, PhD, +82-2-3410-2594, dukna@naver.com
About this study
Official title: A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 13) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment
The primary objective of this preliminary 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 patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients or their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Yband (YDT-201N), Sham-Yband (YDT-201N)
- Keywords
- Mild Cognitive Impairment, MCI, tDCS, transcranial Direct Current Stimulation
- 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
tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| YBand (YDT-201N) | Experimental | transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications) Receives: Device: Yband (YDT-201N) |
| sham-YBand (YDT-201N) | Sham comparator | sham-tDCS application 7 days a week for 12 weeks (total of 84 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 Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13)
Measured: from baseline to Week 6 and Week 12
Secondary outcomes (7)
Change in questionnaire
Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire
Measured: from baseline to Week 12
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
Measured: from baseline to Week 12
Change in tDCS feedback
Measured by tDCS feedback questionnaire
Measured: Week 2, 4, 6 and 12
Change in activities of daily living
Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)
Measured: from baseline to Week 12
Change in Korean version of Geriatric Depression Scale (K-GDS)
Measured: from baseline to Week 6 and Week 12
Change in cognitive function
Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), Clinical Dementia Rating - Sum of Boxes(CDR-SOB), Free and Cued Selective Reminding Test (FCSRT), Cambridge Neuropsychological Test Automated Battery (CANTAB battery), COWAT (Controlled Oral Word Association Test), Stroop test, Digit symbol coding, and Trail making test (TMT)
Measured: from baseline to Week 6 and Week 12
Change in Multifactorial Memory Questionnaire (MMQ)
Measured: from baseline to Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Principal investigator, Duk Lyul Na, Samsung Medical Center
- Investigators
- Duk L. Na, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227966
- Sponsor's protocol ID
- SMC 2014-04-026
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 13) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02227966
- Acronym / sponsor ID
- SMC 2014-04-026
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, MCI, tDCS, transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Aug 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 preliminary 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 patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients or their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YBand (YDT-201N) | Experimental | Device: Yband (YDT-201N)transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications) |
| sham-YBand (YDT-201N) | Sham comparator | Device: Sham-Yband (YDT-201N)sham-tDCS application 7 days a week for 12 weeks (total of 84 applications) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Subjects who have a subjective memory impairment
- Subjects who have Korean version of Mini Mental Status Examination score 24 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 with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem
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 transient ischemic attack.
- Subjects who have neurologic problems on physical examination that cause 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)tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex | Device | sham-YBand (YDT-201N) |
Primary outcome
Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13)
Time frame: from baseline to Week 6 and Week 12
7 secondary outcomes
Change in questionnaire
Time frame: from baseline to Week 12
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
Time frame: from baseline to Week 12
Change in tDCS feedback
Time frame: Week 2, 4, 6 and 12
Change in activities of daily living
Time frame: from baseline to Week 12
Change in Korean version of Geriatric Depression Scale (K-GDS)
Time frame: from baseline to Week 6 and Week 12
Change in cognitive function
Time frame: from baseline to Week 6 and Week 12
Change in Multifactorial Memory Questionnaire (MMQ)
Time frame: from baseline to Week 6 and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Duk L. Na, MD, PhD principal investigator
Samsung Medical Center
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 Samsung Medical Center 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 10 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: status not confirmed, as of the sponsor's last update on 3 Sep 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duk-Lyul Na, MD, PhD (+82-2-3410-3594, dukna@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13) (time frame: from baseline to Week 6 and 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 3 Sep 2014.