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EEG Prediction and Clinical Efficacy of tDCS in Major Depression (DM-TDCS-PREDIC)

2026년 7월 3일 업데이트: Ionclinics & Deionic SL

Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors

The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression.

As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

270

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 스페인
      • Valencia, 스페인
        • 모병
        • Hospital Universiatrio Doctor Peset
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Patients aged 18 years or over.
  • Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013).
  • Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960).
  • Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks.
  • Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer.
  • Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant.
  • Have the ability and willingness to commit to the study team to complete all phases of the study.
  • Volunteer to participate and sign the specific informed consent form for this study.

Exclusion Criteria:

  • Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale.
  • Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool.
  • Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration.
  • Any previous hospitalisation for suicidal behaviour.
  • Presenting with current chronic or severe insomnia (< 4 hours' sleep per night) or sleep apnoea.
  • Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator.
  • History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment.
  • History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders.
  • Any exclusion criteria other than those established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):
  • Metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers
  • Brain stimulation within the last 6 months.
  • Clinical or family history of epilepsy or seizure episodes.
  • Presence of dermatological problems (allergic skin reaction at the electrode site, psoriasis, etc.)
  • History of drug or alcohol abuse during the study or in the 3 months prior (with the exception of nicotine).
  • Pending trial or litigation during the course of the trial.
  • Pregnancy.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: High-dose home-tDCS
장치: High-dose home-tDCS
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F8 (right supraorbital region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).
활성 비교기: Conventional home-tDCS
장치: Conventional home-tDCS
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F4 (left dorsolateral prefrontal region), described by Woodham et al., 2024. The application of tDCS will be carried out at home in this group. Each session will consist of 30 minutes of stimulation. Dose: (1) Week 1 to 3: 1ss/day for 5 days; (2) Week 4 to 10: 1ss/day for 3 days (total 36 sessions).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HDRS-17
기간: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).
Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).

2차 결과 측정

결과 측정
측정값 설명
기간
MDRS
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS).
Baseline; end of treatment (3 week experimental; 10 week active comparator).
C-SSRS
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
HAM-A
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
YMRS
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
RAVLT
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Rey-Auditory Verbal Learning Test (RAVLT).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
SDMT
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the Symbol Digit Modalities Test (SDMT).
Baseline; end of treatment (3 week experimental; 10 week active comparator).
Bristol stool scale
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the Bristol Stool Scale.
Baseline; end of treatment (3 week experimental; 10 week active comparator).
Mediterranean Diet Questionnaire
기간: Baseline
Diet habits of the patients assessed with the Mediterranean diet questionnaire.
Baseline
Meal frequency
기간: Baseline
Meal frequency intake of patients prior to the starting of the project.
Baseline
EQ-5D
기간: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the EuroQoL-5D questionnaire (EQ-5D).
Baseline; end of treatment (3 week experimental; 10 week active comparator).
PGI-C
기간: End of treatment (3 week experimental; 10 week active comparator)
Changes of impression at the end of treatment assess with the Patient Global Impression of Change (PGI-C).
End of treatment (3 week experimental; 10 week active comparator)
Resting state EEG
기간: Baseline
32-channel active-electrode EEG (impedances <5 kΩ) recordings in open and close eye conditions.
Baseline
Stool samples
기간: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Changes in stool sample biomarkers from baseline to end of treatment.
Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).

기타 결과 측정

결과 측정
측정값 설명
기간
환자 기대
기간: 기준선
리커트 척도 1에서 5 (1은 기대 없음, 5는 가능한 최고의 기대)를 사용하여 치료 효과에 대한 기대의 영향을 연구합니다.
기준선
Incremental Cost Effectiveness Ratio
기간: Through study completion, an average of 2 years.
Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.
Through study completion, an average of 2 years.
Costs
기간: Through study completion, an average of 2 years.
Direct and indirect medical and non-medical costs will be collected for the cost-effectiveness analysis.
Through study completion, an average of 2 years.
Utility
기간: Through study completion, an average of 2 years.
Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.
Through study completion, an average of 2 years.
MINI
기간: Baseline
Score of items "Psychotic Disorder" in the MINI International. Neuropsychiatric Interview for selection criteria.
Baseline
Responders to tDCS
기간: Through study completion, an average of 2 years.
A subject is considered a responder if: - Improvement of 50% or more in HDRS-17 or MADRS from baseline to immediate post-treatment.
Through study completion, an average of 2 years.
Adverse Effect
기간: End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: From week 1 to 3, 5 days per week; From week 4 to 10, 3 days per week).
A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.
End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: From week 1 to 3, 5 days per week; From week 4 to 10, 3 days per week).
Successful blinding
기간: Through study completion, an average of 2 years
A method 3 x 3 will be used to evaluate the success of the study's evaluator and statistician.
Through study completion, an average of 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ionclinics & Deionic SL

협력자

Hospital Universitario Doctor Peset
Universidad Europea de Valencia

수사관

  • 연구 책임자: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
  • 연구 의자: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
  • 연구 의자: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 14일

기본 완료 (추정된)

2028년 6월 30일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 7일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 3일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ION001_EEG_TDCS_TDM

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

In accordance with the recommendations of the International Committee of Medical Journal Editors, the de-identified individual participant data (IPD) that underlie the results reported in this study will be shared. The data will become accessible one year after the publication of the primary results and will remain available for five years. Access will be provided to researchers who inquire and agree to a data-use agreement through Ionclinics (investigacion@ionclinics.com/ensayos@ionclinics.com). The data will be de-identified and shared in accordance with applicable regulations and the informed consent provided by the participants.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다