Role of Integrated Treatment in Patients With Functional Neurological Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes and improvement in clinical condition
研究概览
简要总结
The project will investigate the effectiveness of patient-centered integrated treatment.
The correlations between physiotherapy indices, non-invasive brain stimulation, connectivity and psychological support will be analyzed.
详细描述
At the time of recruitment (T0) a multidimensional evaluation will be performed consisting of clinical, neuropsychological, neurophysiological, MRI, data obtained from peripheral blood sampling (10ml). After completing the program (12 weeks), the effect will be assessed according to objectives (T1). The study will also include a follow-up evaluation after 6 months (T2) and 12 months (T3) from the beginning of the treatment to evaluate the persistence of the beneficial effects after some time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent
- •Diagnosis of Functional Neurological Disorder of movement clinically established according to DSM-5 criteria
- •Age between 18 and 65 years (inclusive)
- •Ability to participate in the study protocol
排除标准
- •Inability to provide written informed consent
- •Pregnant women
- •In case of use of non-invasive brain stimulation techniques: the subjects must not present any of the contraindications specific to this method (for further specifications see the "Methods" and the "Stimulation Evaluation Questionnaire" attached to this proposal)
- •Presence of unstable clinical conditions or infections
- •In the case of the use of non-invasive brain stimulation techniques: concomitant use of drugs that can alter the transmission and synaptic plasticity (cannabinoids, L-dopa, antiepileptics, nicotine, baclofen, Selective Serotonin Reuptake Inhibitors (SSRI), botulinum toxin)
- •Inability to support physiotherapy or psychotherapy sessions
结局指标
主要结局
Changes and improvement in clinical condition
时间窗: 1-12 months
the Clinical global impression scale will be used. It is a brief 3-item observer-rated scale that assess severity of illness with assignable scores ranging from 0 to 7 (at every time time point), the global improvement with assignable scores ranging from 0 to 7 (from the second time point), and the efficacy index with assignable scores ranging from 1 to 16 (relationship between therapeutic efficacy and undesirable effects). Higher scores on these scales mean a worse outcome.
Changes in executive functions and attention - step 2
时间窗: 1-12 months
Stroop test
Changes in quality of life
时间窗: 1-12 months
The Short Form Health Survey 36 (SF-36) will be used. It is a generic, multidimensional tool, consisting of 36 questions that can be divided into 8 scales (Physical functioning, limitations due to physical health, limitations due to emotional problems, energy and fatigue, emotional well-being, social activities, pain, general health perception) expressed as percentage values 0-100%. Higher scores on these scales mean a better quality of life.
Evaluation of genetic polymorphisms
时间窗: 1-12 months
A blood sample (10 ml) will be collected to investigate whether genetic polymorphisms related to patients' neuronal plasticity can be related to the response to the protocol.
Changes in executive functions and attention - step 1
时间窗: 1-12 months
Will be used the Symbol Digit Modalities Test, which measures the processing speed, in the oral version of this test (Nocentini et al., 2006). The assignable performance's scores ranging from 0 to 110. The cut-off for normality in italian population for this oral version was 34.2. Higher scores on these scales mean a better processing speed.
Changes in neuroplasticity
时间窗: 1-12 months
Transcranial Magnetic Stimulation (TMS) will be used to evaluate the change of neuronal plasticity in a subgroup of patients who will not present contraindications to the method. The TMS uses short-lived magnetic fields and high intensity applied at the scalp level to activate the neurons of a small region of the cerebral cortex through an electromagnetic induction. When these impulses are applied repeatedly, it is possible to induce plastic modification of cortical excitability. Any increase or decrease in amplitude, which persists after the end of TMS repetitive stimulation, indicates that there have been changes in the cortical, long term potentiation (LTP) or depression (LTD).
次要结局
- Changes in behavioral aspects - step 2(1-12 months)
- Changes in behavioral aspects - step 3(1-12 months)
- Changes in behavioral aspects - step 1(1-12 months)
研究者
Diego Centonze
Professor
Neuromed IRCCS