A Randomized, Sham-controlled Study of Cerebellar Transcranial Direct Current Stimulation (tDCS) and Its Effects on the Neurophysiological Properties of the Sensorimotor Network and Motor Symptom Severity in Patients With Isolated Cervical Dystonia (CD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Changes in sensorimotor network
研究概览
简要总结
Cervical dystonia (CD) is a movement disorder characterized by involuntary muscle contractions of the neck, leading to abnormal head postures and movement, pain and impaired motor function. Current treatments for CD, such as botulinum toxin injections and physical therapy, may not always provide sufficient relief of symptoms and may fail to offer long-term benefits for patients. As a result, new therapeutic approaches are needed. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates neuronal activity. Recent neurophysiological studies suggest that cerebellar tDCS (ctDCS), in particular, could be beneficial in modulating the activity of the sensorimotor network in CD. This clinical trial aims to investigate the effects of ctDCS on the excitability of the sensorimotor network and motor symptom severity in CD patients. Applying transcranial magnetic stimulation (TMS) we will evaluate the effects of anodal, cathodal and sham ctDCS to improve the understanding of the neurophysiological mechanisms underlying CD and the potential therapeutic role of ctDCS.
详细描述
Dystonia is a movement disorder characterized by involuntary, sustained or intermittent muscle contractions, resulting in abnormal movements and postures. CD is the most common form of focal dystonia. It is characterized by abnormal postures or movements of the head. Standard treatment in patients with CD includes regular botulinum toxin injections and physical therapy, but many patients continue to experience symptoms, especially towards the end of the treatment cycle, highlighting the need for alternative treatment options.
One of the challenges in treating CD is the incomplete understanding of its underlying neurophysiological mechanisms. Recently, CD has been recognized as a network disorder, affecting the basal ganglia, the brainstem, the sensorimotor cortex and the cerebellum. So far, there is increasing evidence supporting the role of the cerebellum in the pathophysiology of dystonia, including animal models, neuroimaging and neurophysiological studies, but the exact the role in the proposed dystonia network is only incompletely understood.
TDCS is a form of non-invasive brain stimulation modulating the excitability of superficially located neurons. CtDCS is known to modulate the excitability of neurons of the cerebellar cortex, while the cerebellar nuclei and the brain stem remain unaffected. It has been shown that anodal ctDCS increases and cathodal ctDCS decreases the excitability of the cerebellum.
This randomized and sham-controlled clinical trial aims to investigate the effects of anodal and cathodal ctDCS in CD patients, focusing on both the sensorimotor network excitability and motor symptom severity. Participants will undergo three separated experimental sessions separated by one week, each with a different stimulation condition: anodal, cathodal, and sham ctDCS. Both, the study participants and the experimenter will be blinded to the order of stimulation mode.
The outcome measures will include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of isolated cervical dystonia
- •Written informed consent by the patient
排除标准
- •History of other neurological disorders other than CD
- •Secondary dystonia
- •Severe head tremor
- •Intake of centrally acting medication
- •Contraindications to TMS, such as metallic implants, pregnancy and history of seizures
研究组 & 干预措施
Anodal ctDCS
Patients receive anodal ctDCS stimulation for 20 minutes with 2 mA
干预措施: Anodal and cathodal ctDCS (Device)
Cathodal ctDCS
Patients receive cathodal ctDCS stimulation for 20 minutes with 2 mA
干预措施: Anodal and cathodal ctDCS (Device)
Sham stimulation
Patients receive ctDCS stimulation for 20 minutes with 0 mA
干预措施: Sham stimulation (Device)
结局指标
主要结局
Changes in sensorimotor network
时间窗: Baseline (pre-intervention) and immediately after the intervention
Before and after each tDCS intervention, TMS will be used to assess the neurophysiological properties of the sensorimotor network with four main metrics: 1. Single-pulse TMS (SP-TMS): MEPs will be recorded from the right FDI in response to single-pulse TMS applied over the left primary motor cortex. 2. Short-interval intracortical inhibition (SICI): SICI will be assessed using a paired-pulse TMS protocol, in which two stimuli are delivered at a short interstimulus interval over the primary motor cortex. 3. Short-latency afferent inhibition (SAI): SAI consists of electrical conditioning stimuli to the right index finger preceding the test stimulus delivered by TMS to the left primary motor cortex. 4. Cerebellar-brain-inhibition (CBI): To assess CBI, a conditioning stimulus will be applied over the right cerebellar hemisphere using a second magnetic coil, followed by a cortical test stimulus over the left primary motor cortex.
次要结局
- Clinical symptom severity(Baseline (pre-intervention) and immediately after the intervention)
研究者
Simone Zittel
Dr. med.
Universitätsklinikum Hamburg-Eppendorf