HIGH-DEFINITON TRANSCRANIAL DIRECT CURRENT STIMULATION PRIMED THETA BURST STIMULATION IN TREATMENT RESISTANT DEPRESSION AS MEASURED BY NERVE GROWTH FACTOR: A RANDOMISED SHAM-CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression Scale (CGI) after 2 weeks of HDtDCS primed iTBS in patients of Treatment Resistant Depression.
研究概览
简要总结
Treatment Resistant Depression is a common problem clinicians’ worldwide face. There are no widely agreed upon treatment strategies that satisfactorily solve this problem. rTMS has shown promise as an effective tool for treatment resistant depression with significant lowering of scores in depression rating scales over sham rTMS. Its widespread use has been limited by the number of patients who can be treated by existing protocols and concerns about efficacy and clinical relevance f these results. These concerns can be addressed by studying efficacy of HDtDCS primed iTBS in depression where the iTBS protocol will help reduce the time duration spent on therapy of a single patient and priming has shown promising results towards improving the efficacy of neuromodulation. NGF levels have been studied in depressed individuals as well as patients receiving treatment for depression via various modalities (antidepressants, therapy and neuromodulation). The research findings have not provided enough conclusive evidence to establish NGF as a depression biomarker. To the best of our knowledge no study has been conducted so far to see the association of NGF with HDtDCS primed iTBS in treatment resistant depression.
AIM/KEY RESEARCH QUESTIONS Key questions to be addressed in this study are as follows:
1. Whether HDtDCS priming improves the efficacy of iTBS in treatment resistant depression?
2. Whether application of HDtDCS primed iTBS in patients with Treatment Resistant Depression causes a change in Nerve Growth Factor levels in the serum?
3. Whether NGF levels in active HDtDCS primed group differ significantly from NGF levels in sham HDtDCS primed group?
OBJECTIVES 1. To compare the efficacy of High-Definition transcranial Direct Current Stimulation primed iTBS in treating Treatment Resistant Depression between active and sham HDtDCS priming.
2. To measure levels of Nerve Growth Factor in serum of individuals with Treatment Resistant Depression before and after HDtDCS priming in iTBS.
3. To compare the levels of Nerve Growth Factor levels in the serum of patients receiving Active HDtDCS primed iTBS and Sham HDtDCS primed iTBS.
ALTERNATIVE HYPOTHESIS
1. Active HDtDCS primed iTBS will be more effective in treating treatment resistant depression than sham HDtDCS primed iTBS.
2. Nerve Growth Factor levels in the serum in patients with Treatment Resistant Depression after High-Definition Transcranial Direct Current Stimulation primed intermittent Theta Burst Stimulation will be higher than before treatment.
3. Nerve Growth Factor levels in the serum of patients receiving Active HDtDCS primed iTBS will be higher than Sham HDtDCS primed iTBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Depression using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization,1993)
- •Age between 18- 60 years of either sex
- •The Hamilton Rating Scale for Depression-17 score of at least
- •No response to at least two separate trials of antidepressants of adequate dose and duration.
- •Right-handed.
- •Patients giving written informed consent.
排除标准
- •Lifetime history of non-response to an adequate ECT trial (minimum of 8 sessions).
- •Patient with co morbid active substance dependence in the last 6 months, except nicotine and caffeine.
- •Suicidal intent or any psychiatric emergency.
- •Pregnancy
- •Patients with active psychotic symptoms.
- •Cardiac Pacemaker or Intracranial implant.
- •Neurological comorbidity that could substantially influence depression.
- •Unstable medical illness
- •Patients who have been co prescribed BZD >1mg Clonazepam equivalent or anti-epileptic drugs.
结局指标
主要结局
Improvement in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression Scale (CGI) after 2 weeks of HDtDCS primed iTBS in patients of Treatment Resistant Depression.
时间窗: Improvement in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression Scale (CGI) after 2 weeks of HDtDCS primed iTBS in patients of Treatment Resistant Depression.
次要结局
- Changes in Nerve Growth Factor levels in the serum measured using ELISA kits after treatment with HDtDCS primed iTBS.(Baseline-T1)