Study of the Clinical and Neurophysiological Effects of Transcranial Direct Current Stimulation on Depressive Symptoms in Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory-II (BDI-II)
研究概览
简要总结
Parkinson's disease (PD) is the second most common neurodegenerative disorder, characterized by dopaminergic cell degeneration leading to neurophysiological alterations and a heterogeneous clinical presentation. In addition to motor symptoms, PD patients often experience non-motor symptoms, particularly neuropsychiatric manifestations such as depression, anxiety, and apathy. Depression is one of the most prevalent behavioral symptoms, affecting at least 50% of PD patients, with a higher incidence compared to the general population and other disabling conditions. Two main hypotheses explain the emergence of depressive symptoms: one considers depression a reactive response to progressive disability, while the other links it to the underlying neurobiological mechanisms of PD. Additionally, depression and anxiety frequently co-occur in PD, suggesting shared neurobiological pathways.
Conventional pharmacological treatments only partially address affective symptoms in PD, highlighting the need for innovative non-pharmacological therapies. Transcranial direct current stimulation (tDCS) has gained attention as a potential treatment, showing promising results in improving both motor and affective symptoms in PD. While preliminary studies suggest that tDCS may significantly reduce depressive symptoms, current evidence is insufficient to establish clinical recommendations, necessitating further large-scale, randomized controlled trials.
Objectives
The primary objective of this study is to evaluate the effects of repeated tDCS sessions on depressive symptoms in PD patients. Secondary objectives include:
- Assessing the potential impact of repeated tDCS sessions on anxiety, apathy, sleep quality, and quality of life in PD patients.
- Investigating the neurophysiological mechanisms underlying depression and the effects induced by tDCS.
Methodology
Eligible patients will be randomly assigned to one of two groups:
- Experimental Group: Patients will receive repeated sessions of active tDCS (anodal stimulation). The active electrode (35 cm²) will be placed over the left dorsolateral prefrontal cortex (DLPFC), with the reference electrode (35 cm²) on the contralateral area. Stimulation intensity will be set at 2mA, and each session will last 20 minutes.
- Control Group: Patients will receive sham tDCS sessions. Electrodes will be positioned identically to the active condition, but the current will only be applied for the first 5 seconds to prevent perception of the sham condition while ensuring no neuromodulatory effects. Each session will last 20 minutes.
Both groups will undergo tDCS sessions on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study.
Assessment and Outcome Measures tDCS treatment will be administered in a hospital setting using the Newronika stimulator (CE-certified medical device). The effects on depressive symptoms and neurophysiological mechanisms will be evaluated using validated clinical scales and neurophysiological assessments at multiple time points:
- T0 (Day 1): Baseline assessment before treatment initiation.
- T1 (Day 5): After one week of treatment.
- T5 (Day 33): One week after completing all treatment sessions.
- T6 (Day 54): One month after treatment completion.
This study aims to improve the understanding of tDCS's clinical efficacy and underlying mechanisms in managing affective symptoms in PD. The findings could support the development of evidence-based non-pharmacological interventions for PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society;
- •No dementia (Montreal Cognitive Assessment score ≥ 22/30);
- •Presence of depressive symptoms
- •Pharmacological treatment for motor symptoms stable for at least 1 month
- •Treatment (pharmacological/non-pharmacological) for depressive symptoms stable for at least 3 months.
排除标准
- •Patients with a pacemaker, intracranial electrodes, implanted defibrillators, or any other type of prosthesis;
- •Patients undergoing Deep Brain Stimulation treatment;
- •Patients with epilepsy or a history of seizures;
- •Patients with psychosis;
- •Patients with a history of skull fracture;
- •Pregnant/breastfeeding patients;
- •Patients with suicidal ideation or a suicide attempt in the six months prior to the start of the study;
- •Patients with a history of substance dependence or abuse;
- •Concomitant treatment with medications that may affect tDCS (benzodiazepines, anticonvulsants, pseudoephedrine, dextromethorphan).
研究组 & 干预措施
Sham tDCS
Patients in this group will receive sham transcranial Direct Current Stimulation (tDCS)
干预措施: sham transcranial Direct Current Stimulation (Device)
Active tDCS
Patients in this group will receive active transcranial Direct Current Stimulation (tDCS) (stimulation polarity: anodal).
干预措施: active transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Beck Depression Inventory-II (BDI-II)
时间窗: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
The Beck Depression Inventory-II (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms.
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which mental health professionals use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated from 0 to 6, leading to a total score range of 0 to 60. Higher scores indicate more severe depression.
Visual Analog Scale (VAS)
时间窗: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
The Visual Analog Scale (VAS) for mood is a widely used tool to assess a person's emotional state. It consists of a straight line, usually 100 mm in length, with one end representing the most negative mood state (e.g., very sad, depressed) and the other end representing the most positive mood state (e.g., very happy, elated). The individual marks a point on the line that corresponds to their current mood, and the distance from the "negative" end to the mark is then measured in millimeters, providing a quantitative measure of the individual's emotional state. Scores range from 0 to 10, with higher scores indicating a more positive mood. This scale is easy to use and provides a subjective yet reliable way to track mood changes over time.
次要结局
- State-Trait Anxiety Inventory (STAI)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Apathy Evaluation Scale (AES)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Parkinson's Disease Questionnaire-8 (PDQ-8)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- EEG Peak Frequency in the Beta Band (Hz)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Blink Reflex Area (mV·ms)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Blink Reflex Duration (ms)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Blink Reflex Latency (ms)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Startle Saccadic Reflex Area (mV·ms)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Startle Saccadic Reflex Duration (ms)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))
- Startle Saccadic Reflex Latency (ms)(Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3))