Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by TDCS in Patients with Motor Conversion Disorder - Multicentre Randomized Double Blind Assay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder 3 months after the intervention.
研究概览
简要总结
Conversion disorder refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments and symptoms persist in 35% of patients after 12 years of evolution. Despite a poor prognosis, no treatments have been validated to date.
The development of non-invasive brain stimulation techniques has allowed the creation of treatments focused on dysfunctional brain regions associated with motor conversion disorder. Hypoactivation of prefrontal dorso-lateral cortex underlies the course of functional motor symptoms. Results of the HYCORE study conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.
However, in most repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted and the clinical improvement was related to self-suggestion induced by the motor response produced.
Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.
详细描述
Conversion disorder, also called "functional neurological disorder" (DSM-5), refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments (Carson et al. 2000) and the symptoms persist in 35% of patients after 12 years of evolution (Stone et al. 2003). Despite a poor prognosis, no treatments have been validated to date.
The development of non-invasive brain stimulation techniques has allowed the creation of focused treatments on dysfunctional brain regions associated with motor conversion disorder. A hypoactivation of prefrontal dorso-lateral cortex (PFDLC) underlies the course of functional motor symptoms (Spence et al. 2000); (Voon et al.2011); (Conejero et al. 2017). Results of the HYCORE study that the investigators conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.
However, in the majority of repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted (Pollak et al. 2014) and the clinical improvement was related to self-suggestion induced by the motor response produced.
Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will then be randomized and assigned to one of the 2 groups: the first group will receive a series of 10 effective stimulation sessions (experimental group "active tDCS") and the second group will receive a series of 10 placebo stimulation sessions (control group "sham tDCS").
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
- 否
入选标准
- •The patient must have given his/her informed and signed consent.
- •The patient is at least (≥) 18 years old and 65 years old at the most (≤). The risk of an increased frequency of somatic comorbidity, drug co-prescription, and cognitive impairment prompts us to limit recruitment to age 65 in this study.
- •The patient is hospitalized or followed in consultation.
- •Patient is available for a follow-up of 6 months.
- •With current DSM-5 criteria for conversion disorder during more than 10 days, motor type (i.e. with paralysis or motor weakness) and initial EDSS score ≥ 3 or initial WHO Score is ≥ 2
排除标准
- •The patient is participating in another interventional trial.
- •The patient refuses to sign the consent.
- •It is impossible to correctly inform the patient.
- •The patient is pregnant or breastfeeding.
- •Specialized neurological clinical examination and the performing of brain and medullary MRI reveal an organic neurological involvement.
- •Current episode of mania, hypomania, diagnosis of substance abuse/dependence (excluding smoking), diagnosis of schizophrenia over lifetime, severe neurological pathology (epilepsy, stroke, brain tumor).
- •Patient with a contraindication to MRI (for patients enrolled in Nîmes).
- •Acute eczema at the electrodes loci.
结局指标
主要结局
Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder 3 months after the intervention.
时间窗: 3 months after the intervention
Evaluation of the efficacy of tDCS stimulation of the left PFDLC to treat motor disability in patients with conversion disorder at 3 months after the stimulation procedure with the EDSS (Expanded Disability Status Scale). The Expanded Disability Status Scale is a rating scale of disability divided into eight systems or functional parameters, four major: pyramidal function, cerebellar function, sensory function and brainstem function; four minor: sphincters,vision, mind and others. An encrypted score of increasing severities (0 to 6 or 7) is given to each functional parameter. The overall score of the scale is measured on a scale of 20 levels (0 to 10 per half-point). Up to level 3.5, the score obtained in each functional parameter and the number of affected functional parameters automaticaly determines the EDSS score. From 4 to 7, the definition of each level is also given by the inability to walk (ability to walk without stopping - need for assistance).
次要结局
- Evaluation of the efficacy on motor disability with EDSS score at D7.(7 days after the intervention)
- WHO score at 1 month(1 month after the intervention)
- Evaluation of the efficacy on motor symptoms at D7 with NIHSS(7 days after the intervention)
- Evaluation of the persistence of efficacy on motor symptoms at 1 month(1 month after the intervention)
- WHO score at D7(7 days after the intervention)
- Evaluation of disability related to abnormal movements - CGI at 1 month.(1 month after the intervention)
- Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at D7(7 days after the intervention)
- Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 1 month(1 month after the intervention)
- Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 6 months(6 months after the intervention)
- Tolerance to tDCS stimulation D2 - D6 Brunoni(From 2 days to 6 days after the intervention)
- WHO score at 3 months(3 months after the intervention)
- Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 3 months .(3 months after the intervention)
- Correlation between putative modification of motor symptoms and changes in activity (rest / motor imagery task) of the PFDLC monitored by brain fMRI at Day 0 and Day 7.(Day 0 and Day 7)
- Evaluation of the persistence of efficacy on motor symptoms at 3 months(3 months after the intervention)
- Evaluation of the persistence of efficacy on motor symptoms at 6 months(6 months after the intervention)
- Evaluation of the persistence of efficacy on motor disability with EDSS at 1 month(1 month after the intervention)
- WHO score at 6 months(3 months after the intervention)
- CGI (Clinical Global Impression) scores at Day 7(7 days after the intervention)
- Evaluation of disability related to abnormal movements - CGI at D7.(7 days after the intervention)
- Evaluation of the persistence of efficacy on motor disability with EDSS at 6 months.(6 month after the intervention)
- CGI (Clinical Global Impression) score at 6 months(6 months after the intervention)
- Modified Rankin (mRS) score at D7(7 days after the intervention)
- Modified Rankin (mRS) score at 3 months(3 months after the intervention)
- Modified Rankin (mRS) score at 6 months(6 months after the intervention)
- Evaluation of disability related to abnormal movements - CGI at 3 months.(3 months after the intervention)
- CGI (Clinical Global Impression) score at 3 months(3 months after the intervention)
- Modified Rankin (mRS) score at 1 month(1 month after the intervention)
- Evaluation of disability related to abnormal movements - CGI at 6 months.(6 months after the intervention)
- Evaluation of Dissociative Experiences Scale(6 month after the intervention)
- Evaluate the evolution of dissociation Experiences Scale(6 month after the intervention)
- Efficacy on depression and anxiety level assessed with the HAD score (HADS) at D7(7 days after the intervention)
- Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 1 month(1 month after the intervention)
- Interaction between time from symptom onset to inclusion in the study, initial severity of abnormal movements and efficacy of motor symptom treatment measured with EDSS at 3 months(3 months after the intervention)
- Efficacy on depression and anxiety level assessed with the HAD score (HADS) at 6 months.(6 months after the intervention)
- Evaluate the concordance of the CGI scale between the neurologist's assessment and the psychiatrist's assessment.(6 month after the intervention)