The Effects of tDCS on Depressive Symptoms,Neurocognitive Function and HRV in Unipolar Depression and Bipolar Depression
To Investigate the Effect of Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms, Neurocognitive Function and Heart Rate Variability in Unipolar Depression and Bipolar Depression
연구 개요
상세 설명
Background
Transcranial direct current stimulation encompasses the induction of a relatively weak constant current flow through the cerebral cortex via scalp electrodes . Dependent on stimulation polarity, this results in a modulation of cortical excitability and spontaneous neural activity. The technique was established in the 1950s and 1960s primarily in animals. In these early studies it was shown that subthreshold DC stimulation increases spontaneous neuronal activity if the anode is placed above or within the cortex, while exposure to cathodal polarity results in reduced activity. This is caused by a subthreshold membrane depolarization by anodal and a hyperpolarization by cathodal stimulation. It was demonstrated in humans that the after-effects of tDCS depend on modifications of NMDA receptor-efficacy. The after-effects of tDCS are blocked by the NMDA receptor antagonist dextromethorphan, and prolonged by the partial NMDA receptor-agonist D-cycloserine. This tDCS polarity-dependent alteration of NMDA receptor function seems to be initiated by the respective membrane potential shift and probably by the accompanying cortical activity modification,because it is prevented by the sodium channel blocker carbamazepine. Intraneuronal calcium concentration also contributes, because calcium channel antagonists eliminate the excitability-enhancing after-effects of anodal tDCS. Recently, tDCS has been reported to be a novel, non-invasive and safe therapeutic tool to treat neuropsychiatric disorders including depression. This therapeutic tool has been reported to show promising effect in treating unipolar and bipolar depression. However, the sample sizes have been small. Further work is needed to see if these early promising studies replicate. Much evidence has indicated that patients with depression show hypoactivity over left dorsolateral prefrontal cortex (DLPFC) and hyperactivity over right DLPFC. We therefore hypothesize that tDCS over DLPFC with anode placed at left DLPFC and cathode placed at right DLPFC would reduce depressive symptoms in patients with unipolar depression and bipolar depression.
The study aimed to investigate whether tDCS over DLPFC could modify depressive symptoms, neurocognitive function and heart rate variability of unipolar and bipolar depression.
Study design: open-label study.
Participants: 60 patients with unipolar depression and 60 with bipolar depression.
Others: see Arms and Interventions, Eligibility Criteria or Outcome Measures.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만, 114
- Tri-Service General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients who met DSM-IV-TR criteria for major depressive disorder and bipolar depression and had moderate to severe depression severity (HAM-D score more than 17) were included in the study.
Exclusion Criteria:
- pregnancy or breastfeeding.
- having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence.
- having contraindications for transcranial electrical/magnetic stimulation.
- having intracranial metal foreign bodies.
- having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: tDCS over DLPFC
Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www.
neuroconn.de/dc-stimulator_plus_en/)
was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2).
The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4.
Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays.
The twice daily sessions were separated by at least 3 hours.
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We applied tDCS over dorsolateral prefrontal cortex (DLPFC) for these depressed patients.
Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www.
neuroconn.de/dc-stimulator_plus_en/)
was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2).
The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4.
Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays.
The twice daily sessions were separated by at least 3 hours.
All patients were maintained on their treatment throughout the study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes from baseline score of Hamilton Depression Rating Scale (HAM-D) at the timepoint immediately after tDCS, at one week and one month after tDCS
기간: One month
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Depression severity
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One month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes from baseline score of Young Mania Rating Scale (YMRS) at the timepoint immediately after tDCS, at one week and one month after tDCS
기간: One month
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Hypomania/mania severity
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One month
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Changes from baseline score of Hamilton Anxiety Rating Scale (HAM-A) at the timepoint immediately after tDCS, at one week and one month after tDCS
기간: One month
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Anxiety severity.
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One month
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Changes from basline heart rate variability (HRV) at the timepoint immediately after tDCS, at one week and one month after tDCS
기간: One month
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Index of autonomic functioning.
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One month
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Changes from baseline results of continuous performance test (CPT) at the timepoint immediately after tDCS, at one week and one month after tDCS
기간: One month
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Performance of prefrontal-mediated task.
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One month
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
tDCS over DLPFC에 대한 임상 시험
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