tDCS in Depression in Perinatal Women

NCT06015425 | Unknown DMC

• 1 other identifier: HI23C0297
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. Researchers will compare Visit 1 to Visit 3 in one group.

Conditions

Depression; Pregnancy

Keywords

Transcranial Direct Current Stimulation; Depression; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At 4 weeks after treatment

Secondary Outcomes (2)

• Center for Epidemiologic Studies Depression Scale (CESD-R) score change for depressive symptoms

  At 4 weeks after treatment

• Korean Version of Edinburgh Postnatal Depression Scale (K-EPDS) score change for depressive symptoms

  At 4 weeks after treatment

Other Outcomes (4)

• Actigraphy/Lifelog Service Use

  At 4 weeks after treatment

• Korean version of the Insomnia Severity Index (ISI-K) score change for Insomnia

  At 4 weeks after treatment

• Korean version of Depression Anxiety Stress Scales-21 items (K-DASS-21) score change for Depression, anxiety, and stress

  At 4 weeks after treatment

Study Arms (1)

YMS-201B+

EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS) application 5 \~7 days a week for 4 weeks (total of 20\~28 applications)

Device: MINDD STIM+

Interventions

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)

YMS-201B+

Eligibility Criteria

• Age: 19 Years - 50 Years
• Gender Eligibility Details: Women who have a uterus and ovaries and are likely to become pregnant and give birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Severance Hospital: collaborator
• Ilsan Cha hospital: collaborator
• Bundang CHA Hospital: collaborator
• Ybrain Inc.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Republic of Korea, 03080, South Korea

Location

Related Publications (17)

• 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.

  PMID: 34300358 BACKGROUND

• Caparros-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.

  PMID: 32615801 BACKGROUND

• de 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.

  PMID: 15780702 BACKGROUND

• Grimm 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.

  PMID: 17888408 BACKGROUND

• Hollins 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.

  PMID: 18007135 BACKGROUND

• Kurzeck 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.

  PMID: 30110930 BACKGROUND

• Stein 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.

  PMID: 2015451 BACKGROUND

• Vigod 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.

  PMID: 25234606 BACKGROUND

• Vigod 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.

  PMID: 31257092 BACKGROUND

• Wu 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.

  PMID: 35486403 BACKGROUND

• Oh 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.

  PMID: 37119219 BACKGROUND

• Bikson 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.

  PMID: 37201865 BACKGROUND

• Lorenzetti 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.

  PMID: 19237202 BACKGROUND

• Das 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.

  PMID: 27965533 BACKGROUND

• Fregni 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.

  PMID: 16542193 BACKGROUND

• Rigonatti SP, Boggio PS, Myczkowski ML, Otta E, Fiquer JT, Ribeiro RB, Nitsche MA, Pascual-Leone A, Fregni F. Transcranial direct stimulation and fluoxetine for the treatment of depression. Eur Psychiatry. 2008 Jan;23(1):74-6. doi: 10.1016/j.eurpsy.2007.09.006. Epub 2007 Nov 19. No abstract available.

  PMID: 18023968 BACKGROUND

• Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.

  PMID: 23389323 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Hee Young Cho

  Seoul National University Hospital

  STUDY DIRECTOR

• san lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Min-Kyoung Kim

  Ilsan Cha hospital

  PRINCIPAL INVESTIGATOR

• Chun Il Park

  Bundang CHA Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Young Cho

CONTACT

+82 10-4127-9823; hycho.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 31, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)