Efficacy of precision-based HD-tDCS over conventional HD-tDCS as measured by functional neuroimaging and cortical inhibition paradigms in young-onset mania: An active comparison study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement of symptoms of young onset mania, as measured by YMRS Score and severity of illness, as measured by CGI scores after receiving adjunctive precision-based HD-tDCS.
研究概览
简要总结
As more accurate neuromodulation systems combining high-resolution EEG and anatomical biomarkers develop, it is prudent to evaluate how refined and effective precision neuromodulation is as compared to conventional techniques. Young onset mania provides an ideal challenge for such a comparison considering its poorer prognosis and pharmacological refractoriness. This study aims to be the first to directly compare precision and conventional neuromodulation in child and adolescent populations. It also seeks to study and compare, for the first time, changes in neuroimaging parameters caused due to precision and conventional techniques. By correlating perturbation-induced changes in cortical inhibition paradigms and functional connectivity of cerebral circuits, we aim to introduce a more objective measure of therapeutic efficacy and response, as opposed to relying solely on subjective clinical scales. Furthermore, we aim to study for the first time, task-based differential activation of brain areas in young onset mania.
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
- 10.00 Year(s) 至 20.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Bipolar type I disorder (6A60) with current episode manic according to the International Classification of Diseases, Eleventh Revision (ICD-11) (WHO, 2019).
- •The age of onset of mania less than 18 years of age belonging to either sex.
- •The current age of the patient is between 10 to 20 years of age.
- •Written informed assent/consent on behalf of participant, parents, guardians or caregivers as applicable.
排除标准
- •Presence of comorbid other psychiatric or neurological disorders.
- •History of major medical illness.
- •History of epilepsy, sustained brain damage or any neurological procedures.
- •Subjects who have received ECT/rTMS in the past two months.
- •Developmental delay or mental retardation.
- •Any contraindication to undergo fMRI, TMS or HD-tDCS
- •Mixed episodes of depression and mania measured as a score of more than six on HAM-D.
结局指标
主要结局
Improvement of symptoms of young onset mania, as measured by YMRS Score and severity of illness, as measured by CGI scores after receiving adjunctive precision-based HD-tDCS.
时间窗: Primary outcomes are assessed 2 and 6 weeks after intervention.
次要结局
- Improvement of functional connectivity, as measured by neuroimaging and enhancement of cortical inhibition as measured by cortical inhibition paradigms in young onset mania after receiving adjunctive precision-based HD-tDCS.(Secondary outcomes are assessed 2 and 6 weeks after intervention.)
研究者
Dr Srijan Das
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI