DepressionNCT06015425
tDCS in Depression in Perinatal Women
A study testing MINDD STIM+ in people with Depression and Pregnancy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is Real-world data(RWD) collection and Real-world evidence(RWE) clinical demonstration study of Transcranial direct current stimulation(tDCS) for the treatment of depression in perinatal women. Participants will apply tDCS by themselves for 4 weeks at home. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Depression, Pregnancy
- What is being tested?
- MINDD STIM+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2023to 31 Dec 2025
- 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 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mild to moderate MDD among perinatal women aged between 19 and 50 years of age
- MDD refers to cases that clinically satisfy the diagnostic criteria for unipolar and nonpsychotic major depressive disorder according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Mild and moderate symptoms are defined as non-severe conditions corresponding to a Beck Depression Inventory-II (BDI-II) score of 18 to 28 points or a Montgomery-Asberg Depression Rating Scale (MADRS) score of 14 to 34 points, which are the main evaluation variables.
- Those who can read and understand the subject explanation and consent form, and have Korean language proficiency at a level capable of responding to questionnaires
- In this study, since tDCS is not an absolute contraindication even for pregnant women, it is possible to participate in clinical demonstration studies unless the subject exclusion criteria are met.
Who cannot join
- Male
- Those who have been diagnosed with Post-Traumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD) among psychiatric comorbid anxiety disorders
- Those diagnosed with bipolar or psychotic major depressive disorder
- Among those diagnosed with Seizure Disorders, those who are judged by the clinician to be inappropriate for this clinical trial
- A person who scores 5 or more in MADRS question 10 (suicidal ideation)
- A person who has attempted suicide within 6 months from the date of screening or a person who, as determined by the clinician, has a suicide risk that requires hospitalization in a protective ward
Show all 15Show fewer
- Those who are judged to have problems with EEG and DC stimulation electrode attachment due to scalp deformities, inflammatory reactions, or other dermatological problems
- A person who is judged to have other reasons for prohibiting the use of tDCS medical devices (refer to the example below)
- A person who inserts a head metal plate
- Users of implantable medical devices such as pacemakers and implantable cardioverter defibrillators.
- Wearers of life-sustaining medical devices such as artificial heart lungs or users of implantable medical devices such as electrocardiographs
- Those who show clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system that affect the application and effectiveness evaluation of medical devices during the study period (e.g., those who have difficulty breathing while sitting still) If you have an endocrine system/central nervous system disease that is not controlled by medication, etc.)
- Those who participated in other clinical trials within 30 days from the date of screening
- Those who have applied transcranial direct current stimulation within 6 months from the date of screening
- In addition to the above, those who have clinically significant findings that are considered inappropriate for this clinical demonstration study as determined medically by the investigator or person in charge
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Republic of Korea, 03080
About this study
Official title: Real-world Data Collection and Real-world Evidence Clinical Demonstration Study of tDCS for the Treatment of Depression in Perinatal Women
The goal of this clinical trial is Real-world data(RWD) collection and Real-world evidence(RWE) clinical demonstration study of Transcranial direct current stimulation(tDCS) for the treatment of depression in perinatal women. Participants will apply tDCS by themselves for 4 weeks at home. Researchers will compare Visit 1 to Visit 3 in one group.
Read the detailed description
The prevalence of postpartum depression is known to be 10-20%, but the number of people who actually experience postpartum depression is reported to be higher. According to the 2018 survey on postpartum care by the Ministry of Health and Welfare(Korea), 50.3% of mothers experienced postpartum depression during the postpartum care period, and 33.9% of mothers aged 9 to 20 months postpartum were at risk of postpartum depression.
To this end, since the 1980s, safer and more effective depression methods such as tDCS and repetitive transcranial magnetic stimulation (rTMS), which are noninvasive brain stimulation methods using electricity and magnetism, have been developed. Research has begun as a treatment technique, and rTMS has been approved for depression by the US FDA in 2008 and the Ministry of Food and Drug Safety in Korea in 2013. It is becoming.
According to the report by Sreeraj (2016), tDCS monotherapy resulted in significant improvement in depressive and anxiety symptoms during pregnancy, and reported that it is likely to build an evidence base to strengthen the clinical usefulness of tDCS during pregnancy.
Therefore, through the actual use application of tDCS for the treatment of depression in perinatal women who are in the blind spot of drug treatment, RWD and RWE are collected.
- Conditions
- Depression, Pregnancy
- Being tested
- MINDD STIM+
- Keywords
- Transcranial Direct Current Stimulation, Depression, Pregnancy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDD STIM+Device
transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| YMS-201B+ | Experimental | transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 4 weeks (total of 20~28 applications) Receives: Device: MINDD STIM+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
Average change of K-BDI-II at 4 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
Measured: At 4 weeks after treatment
Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms
It is evaluated on 10 items, including outward sadness, spontaneously reported sadness, internal tension, sleep deprivation, loss of appetite, difficulty concentrating, laziness (boredom), loss of feeling, pessimistic thoughts, and suicidal thoughts. It is evaluated as ~6 points, and the total score is 0~60 points, and the change in score after 4 weeks is the Primary Outcome Measure.
Measured: At 4 weeks after treatment
Secondary outcomes (2)
Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms
The CESD developed by Radloff et al. in 1977 for the evaluation of depressive symptoms was revised to reflect the diagnostic criteria for major depressive episodes in the DSM-IV (Eaton, 2004). Dysphoria, anhedonia, psychomotor retardation/agitation, suicide Items reflecting accidents have been added. Self-report 20-item scale, each item measured from 0 to 4 points and the change in score after 4 weeks is the Secondary Outcome Measures.
Measured: At 4 weeks after treatment
Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms
It evaluates the symptoms experienced while experiencing postpartum depression rather than a general depression test. It was developed by Cox et al. in 1987 and adapted and standardized in Korea by Kim Yong-gu et al. in 2005. With a total score of 30, a score of 10 or more, the cut-off point, is evaluated as having depressive symptoms and the change in score after 4 weeks is the Secondary Outcome Measures.
Measured: At 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Ilsan Cha hospital, Bundang CHA Hospital, Ybrain Inc.
- Responsible party
- Principal investigator, CHO HEE YOUNG, Seoul National University Hospital
- Investigators
- Hee Young Cho, Study director, Seoul National University Hospitalsan lee, Principal investigator, Severance HospitalMin-Kyoung Kim, Principal investigator, Ilsan Cha hospitalChun Il Park, Principal investigator, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015425
- Sponsor's protocol ID
- HI23C0297
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Baran J, Leszczak J, Baran R, Biesiadecka A, Weres A, Czenczek-Lewandowska E, Kalandyk-Osinko K. Prenatal and Postnatal Anxiety and Depression in Mothers during the COVID-19 Pandemic. J Clin Med. 2021 Jul 20;10(14):3193. doi: 10.3390/jcm10143193.
PubMed 34300358Caparros-Gonzalez RA, Alderdice F. The COVID-19 pandemic and perinatal mental health. J Reprod Infant Psychol. 2020 Jul;38(3):223-225. doi: 10.1080/02646838.2020.1786910. No abstract available.
PubMed 32615801de Tychey C, Spitz E, Briancon S, Lighezzolo J, Girvan F, Rosati A, Thockler A, Vincent S. Pre- and postnatal depression and coping: a comparative approach. J Affect Disord. 2005 Apr;85(3):323-6. doi: 10.1016/j.jad.2004.11.004.
PubMed 15780702Grimm S, Beck J, Schuepbach D, Hell D, Boesiger P, Bermpohl F, Niehaus L, Boeker H, Northoff G. Imbalance between left and right dorsolateral prefrontal cortex in major depression is linked to negative emotional judgment: an fMRI study in severe major depressive disorder. Biol Psychiatry. 2008 Feb 15;63(4):369-76. doi: 10.1016/j.biopsych.2007.05.033. Epub 2007 Sep 21.
PubMed 17888408Hollins K. Consequences of antenatal mental health problems for child health and development. Curr Opin Obstet Gynecol. 2007 Dec;19(6):568-72. doi: 10.1097/GCO.0b013e3282f1bf28.
PubMed 18007135Kurzeck AK, Kirsch B, Weidinger E, Padberg F, Palm U. Transcranial Direct Current Stimulation (tDCS) for Depression during Pregnancy: Scientific Evidence and What Is Being Said in the Media-A Systematic Review. Brain Sci. 2018 Aug 14;8(8):155. doi: 10.3390/brainsci8080155.
PubMed 30110930Stein A, Gath DH, Bucher J, Bond A, Day A, Cooper PJ. The relationship between post-natal depression and mother-child interaction. Br J Psychiatry. 1991 Jan;158:46-52. doi: 10.1192/bjp.158.1.46.
PubMed 2015451Vigod S, Dennis CL, Daskalakis Z, Murphy K, Ray J, Oberlander T, Somerton S, Hussain-Shamsy N, Blumberger D. Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial. Trials. 2014 Sep 18;15:366. doi: 10.1186/1745-6215-15-366.
PubMed 25234606Vigod SN, Murphy KE, Dennis CL, Oberlander TF, Ray JG, Daskalakis ZJ, Blumberger DM. Transcranial direct current stimulation (tDCS) for depression in pregnancy: A pilot randomized controlled trial. Brain Stimul. 2019 Nov-Dec;12(6):1475-1483. doi: 10.1016/j.brs.2019.06.019. Epub 2019 Jun 19.
PubMed 31257092Wu Y, Espinosa KM, Barnett SD, Kapse A, Quistorff JL, Lopez C, Andescavage N, Pradhan S, Lu YC, Kapse K, Henderson D, Vezina G, Wessel D, du Plessis AJ, Limperopoulos C. Association of Elevated Maternal Psychological Distress, Altered Fetal Brain, and Offspring Cognitive and Social-Emotional Outcomes at 18 Months. JAMA Netw Open. 2022 Apr 1;5(4):e229244. doi: 10.1001/jamanetworkopen.2022.9244.
PubMed 35486403Oh J, Jeon S, Ha TH, Myung W, Lee SH, Ko YH, Kim DH, Lee HY, Chae JH. Effect of Home-based Self-administered Transcranial Direct Stimulation in Patients with Mild to Moderate Major Depressive Disorder: A Single-arm, Multicentral Trial. Clin Psychopharmacol Neurosci. 2023 May 30;21(2):271-278. doi: 10.9758/cpn.2023.21.2.271.
PubMed 37119219Bikson M, Ganho-Avila A, Datta A, Gillick B, Joensson MG, Kim S, Kim J, Kirton A, Lee K, Marjenin T, Onarheim B, Rehn EM, Sack AT, Unal G. Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. Brain Stimul. 2023 May-Jun;16(3):840-853. doi: 10.1016/j.brs.2023.05.008. Epub 2023 May 16.
PubMed 37201865Lorenzetti V, Allen NB, Fornito A, Yucel M. Structural brain abnormalities in major depressive disorder: a selective review of recent MRI studies. J Affect Disord. 2009 Sep;117(1-2):1-17. doi: 10.1016/j.jad.2008.11.021. Epub 2009 Feb 23.
PubMed 19237202Das S, Holland P, Frens MA, Donchin O. Impact of Transcranial Direct Current Stimulation (tDCS) on Neuronal Functions. Front Neurosci. 2016 Nov 30;10:550. doi: 10.3389/fnins.2016.00550. eCollection 2016.
PubMed 27965533Fregni F, Boggio PS, Nitsche MA, Marcolin MA, Rigonatti SP, Pascual-Leone A. Treatment of major depression with transcranial direct current stimulation. Bipolar Disord. 2006 Apr;8(2):203-4. doi: 10.1111/j.1399-5618.2006.00291.x. No abstract available.
PubMed 16542193
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Data Collection and Real-world Evidence Clinical Demonstration Study of tDCS for the Treatment of Depression in Perinatal Women
- ClinicalTrials.gov ID
- NCT06015425
- Acronym / sponsor ID
- HI23C0297
- Conditions
- Depression, Pregnancy
- Keywords
- Transcranial Direct Current Stimulation, Depression, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, Ilsan Cha hospital, Bundang CHA Hospital, Ybrain Inc.
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2023 (actual)
- 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 goal of this clinical trial is Real-world data(RWD) collection and Real-world evidence(RWE) clinical demonstration study of Transcranial direct current stimulation(tDCS) for the treatment of depression in perinatal women. Participants will apply tDCS by themselves for 4 weeks at home. Researchers will compare Visit 1 to Visit 3 in one group.
Detailed description
The prevalence of postpartum depression is known to be 10-20%, but the number of people who actually experience postpartum depression is reported to be higher. According to the 2018 survey on postpartum care by the Ministry of Health and Welfare(Korea), 50.3% of mothers experienced postpartum depression during the postpartum care period, and 33.9% of mothers aged 9 to 20 months postpartum were at risk of postpartum depression.
To this end, since the 1980s, safer and more effective depression methods such as tDCS and repetitive transcranial magnetic stimulation (rTMS), which are noninvasive brain stimulation methods using electricity and magnetism, have been developed. Research has begun as a treatment technique, and rTMS has been approved for depression by the US FDA in 2008 and the Ministry of Food and Drug Safety in Korea in 2013. It is becoming.
According to the report by Sreeraj (2016), tDCS monotherapy resulted in significant improvement in depressive and anxiety symptoms during pregnancy, and reported that it is likely to build an evidence base to strengthen the clinical usefulness of tDCS during pregnancy.
Therefore, through the actual use application of tDCS for the treatment of depression in perinatal women who are in the blind spot of drug treatment, RWD and RWE are collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YMS-201B+ | Experimental | Device: MINDD STIM+transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 4 weeks (total of 20~28 applications) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with mild to moderate MDD among perinatal women aged between 19 and 50 years of age
- MDD refers to cases that clinically satisfy the diagnostic criteria for unipolar and nonpsychotic major depressive disorder according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Mild and moderate symptoms are defined as non-severe conditions corresponding to a Beck Depression Inventory-II (BDI-II) score of 18 to 28 points or a Montgomery-Asberg Depression Rating Scale (MADRS) score of 14 to 34 points, which are the main evaluation variables.
- Those who can read and understand the subject explanation and consent form, and have Korean language proficiency at a level capable of responding to questionnaires
- In this study, since tDCS is not an absolute contraindication even for pregnant women, it is possible to participate in clinical demonstration studies unless the subject exclusion criteria are met.
Key exclusion criteria (15 listed)
- Male
- Those who have been diagnosed with Post-Traumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD) among psychiatric comorbid anxiety disorders
- Those diagnosed with bipolar or psychotic major depressive disorder
- Among those diagnosed with Seizure Disorders, those who are judged by the clinician to be inappropriate for this clinical trial
- A person who scores 5 or more in MADRS question 10 (suicidal ideation)
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 |
|---|---|---|
| MINDD STIM+transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | YMS-201B+ |
Primary outcome
Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms
Time frame: At 4 weeks after treatment
Average change of K-BDI-II at 4 weeks after treatment compare to the base respectively. This scale contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.The lower the total score, the better the symptoms.
Montgomery-Åsberg Depression Rating Scale (MADRS) score change for depressive symptoms
Time frame: At 4 weeks after treatment
It is evaluated on 10 items, including outward sadness, spontaneously reported sadness, internal tension, sleep deprivation, loss of appetite, difficulty concentrating, laziness (boredom), loss of feeling, pessimistic thoughts, and suicidal thoughts. It is evaluated as ~6 points, and the total score is 0~60 points, and the change in score after 4 weeks is the Primary Outcome Measure.
2 secondary outcomes
Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms
Time frame: At 4 weeks after treatment
Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms
Time frame: At 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 34300358Baran J, Leszczak J, Baran R, Biesiadecka A, Weres A, Czenczek-Lewandowska E, Kalandyk-Osinko K. Prenatal and Postnatal Anxiety and Depression in Mothers during the COVID-19 Pandemic. J Clin Med. 2021 Jul 20;10(14):3193. doi: 10.3390/jcm10143193.
- Background: PubMed 32615801Caparros-Gonzalez RA, Alderdice F. The COVID-19 pandemic and perinatal mental health. J Reprod Infant Psychol. 2020 Jul;38(3):223-225. doi: 10.1080/02646838.2020.1786910. No abstract available.
- Background: PubMed 15780702de Tychey C, Spitz E, Briancon S, Lighezzolo J, Girvan F, Rosati A, Thockler A, Vincent S. Pre- and postnatal depression and coping: a comparative approach. J Affect Disord. 2005 Apr;85(3):323-6. doi: 10.1016/j.jad.2004.11.004.
- Background: PubMed 17888408Grimm S, Beck J, Schuepbach D, Hell D, Boesiger P, Bermpohl F, Niehaus L, Boeker H, Northoff G. Imbalance between left and right dorsolateral prefrontal cortex in major depression is linked to negative emotional judgment: an fMRI study in severe major depressive disorder. Biol Psychiatry. 2008 Feb 15;63(4):369-76. doi: 10.1016/j.biopsych.2007.05.033. Epub 2007 Sep 21.
- Background: PubMed 18007135Hollins K. Consequences of antenatal mental health problems for child health and development. Curr Opin Obstet Gynecol. 2007 Dec;19(6):568-72. doi: 10.1097/GCO.0b013e3282f1bf28.
- Background: PubMed 30110930Kurzeck AK, Kirsch B, Weidinger E, Padberg F, Palm U. Transcranial Direct Current Stimulation (tDCS) for Depression during Pregnancy: Scientific Evidence and What Is Being Said in the Media-A Systematic Review. Brain Sci. 2018 Aug 14;8(8):155. doi: 10.3390/brainsci8080155.
- Background: PubMed 2015451Stein A, Gath DH, Bucher J, Bond A, Day A, Cooper PJ. The relationship between post-natal depression and mother-child interaction. Br J Psychiatry. 1991 Jan;158:46-52. doi: 10.1192/bjp.158.1.46.
- Background: PubMed 25234606Vigod S, Dennis CL, Daskalakis Z, Murphy K, Ray J, Oberlander T, Somerton S, Hussain-Shamsy N, Blumberger D. Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial. Trials. 2014 Sep 18;15:366. doi: 10.1186/1745-6215-15-366.
- Background: PubMed 31257092Vigod SN, Murphy KE, Dennis CL, Oberlander TF, Ray JG, Daskalakis ZJ, Blumberger DM. Transcranial direct current stimulation (tDCS) for depression in pregnancy: A pilot randomized controlled trial. Brain Stimul. 2019 Nov-Dec;12(6):1475-1483. doi: 10.1016/j.brs.2019.06.019. Epub 2019 Jun 19.
- Background: PubMed 35486403Wu Y, Espinosa KM, Barnett SD, Kapse A, Quistorff JL, Lopez C, Andescavage N, Pradhan S, Lu YC, Kapse K, Henderson D, Vezina G, Wessel D, du Plessis AJ, Limperopoulos C. Association of Elevated Maternal Psychological Distress, Altered Fetal Brain, and Offspring Cognitive and Social-Emotional Outcomes at 18 Months. JAMA Netw Open. 2022 Apr 1;5(4):e229244. doi: 10.1001/jamanetworkopen.2022.9244.
- Background: PubMed 37119219Oh J, Jeon S, Ha TH, Myung W, Lee SH, Ko YH, Kim DH, Lee HY, Chae JH. Effect of Home-based Self-administered Transcranial Direct Stimulation in Patients with Mild to Moderate Major Depressive Disorder: A Single-arm, Multicentral Trial. Clin Psychopharmacol Neurosci. 2023 May 30;21(2):271-278. doi: 10.9758/cpn.2023.21.2.271.
- Background: PubMed 37201865Bikson M, Ganho-Avila A, Datta A, Gillick B, Joensson MG, Kim S, Kim J, Kirton A, Lee K, Marjenin T, Onarheim B, Rehn EM, Sack AT, Unal G. Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. Brain Stimul. 2023 May-Jun;16(3):840-853. doi: 10.1016/j.brs.2023.05.008. Epub 2023 May 16.
- Individual participant dataSharing planned: Yes
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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.
Hee Young Cho study director
Seoul National University Hospital
san lee principal investigator
Severance Hospital
Min-Kyoung Kim principal investigator
Ilsan Cha 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 MINDD STIM+ in people with Depression and Pregnancy, run by Seoul National University 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 5 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 31 Aug 2023. 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 Hee Young Cho (+82 10-4127-9823, hycho.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean-Beck Depression Inventory-II (K-BDI-II) score change for depressive symptoms (time frame: At 4 weeks after treatment). 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 NCT06015425, which also lists 17 linked publications.
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 31 Aug 2023.