Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
概览
- 阶段
- 不适用
- 干预措施
- Transcranial Direct Current Stimulation
- 疾病 / 适应症
- Idiopathic Parkinson's Disease
- 发起方
- Johns Hopkins University
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
- 状态
- 暂停
- 最后更新
- 2个月前
概览
简要总结
This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.
研究者
入排标准
入选标准
- •Abel to provide written informed consent is obtained in the English language
- •Age 18 to 95 years old
- •Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease
- •Report disabling depressive or neuropsychiatric symptoms prior to study entry
- •Capacity to understand the nature of the study;
排除标准
- •Known structural brain disease such as a neoplasm, abscess etc.
- •Pre-existing skull / scalp defects that would impede standardized electrode placement
- •Current electronic or metal implants
- •Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
- •Concurrent treatment with medication which may affect tDCS (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine)
- •Endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
- •History of substance abuse or dependence in the 2 months prior to screening;
- •Considered to be at significant risk of committing homicide;
- •Unstable medical condition;
- •Score less than 22 on the Montreal Cognitive Assessment (MoCA)
研究组 & 干预措施
Sham tDCS
Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA
干预措施: Transcranial Direct Current Stimulation
Active tDCS
Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA
干预措施: Transcranial Direct Current Stimulation
结局指标
主要结局
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
时间窗: 1 months
Primary outcome measure will be the number of participants who demonstrate remission of depressive symptoms OR improvement of 50% (i.e. response) on the Montgomery-Asberg Scale of Depression (MADRS)
次要结局
- Subjective improvement of Anxiety Symptoms via Rating Scale(1 month)
- Performance on abbreviated cognitive battery(1 month)
- Subjective Depression Severity rated via self-report on depression inventory(1 months)
- Apathy Scores as measure by a self-report scale (the Apathy Scale)(1 months)
- Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report(1 month)
- Improvement of Parkinsonian Motor Symptoms(1 month)