Comparing the effect of Transcranial direct current stimulation versus Transauricular vagus nerve stimulation on depressive symptoms in cancer patients undergoing radiation therapy- A Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- PHQ-9 scale is used to assess the depression and is assessed post intervention
研究概览
简要总结
This study focuses on addressing the high prevalence of depression in cancer patients receiving radiotherapy, which negatively affects their quality of life, treatment adherence, and outcomes. Since pharmacological options may add side effects in patients already on multiple medications, this study explores two non-invasive neuromodulation techniques—tDCS and taVNS—as safer alternatives. Using a randomized clinical trial design with 22 participants, patients will be assigned to receive either tDCS or taVNS along with conventional physiotherapy for two weeks, and outcomes will be assessed using PHQ-9, Fatigue severity scale, and EORTC QLQ-C30 scales. The aim is to compare the effectiveness of tDCS and taVNS in reducing depressive symptoms, fatigue, and improving quality of life in this patient group.
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 Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant diagnosed with cancer who are in the age group of 40 to 80 years of both genders.
- •2.Participants willing to participate.
- •Participants with beck depression inventory more than 13.
排除标准
- •1.Participants having any metal implants.
- •2.Participants who are undergoing any forms of psychotherapy.
- •3.Participants having history of uncontrolled epilepsy.
- •4.Participants having pacemaker.
- •6.Participants with cardiovascular risk or unstable cardiac disease.
- •7.Participants with unstable medical conditions.
- •8.Participants with active skin disease at electrode sites.
结局指标
主要结局
PHQ-9 scale is used to assess the depression and is assessed post intervention
时间窗: baseline and at 2 weeks
次要结局
- fatigue severity scale is used to assess fatigue level of the patient(baseline & at 2 weeks)
- EORTC QOL-C30 scale is used to assess the quality of life(baseline & at 2 weeks)
研究者
Gayatri Govindankutty Marar
KLE Institute of Higher Education and Research Center