Impact of Theta Burst Repetitive Transcranial Magnetic Stimulation on the Patient's Self-reported Improvement in Their Motor Functional Neurological Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Difference in PGIC (Patient Global Impression of Change) score before versus after treatment.
研究概览
简要总结
Functional neurological disorder (FND) is a condition that causes significant suffering and disability. It is defined by the presence of neurological symptoms that interfere with an individual's functioning and are not consistent with any known anatomical lesion but that causes significant functional impairment. The investigators are particularly interested in motor symptoms (abnormal movements or motor deficits).
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and acceptable treatment that has proven effective in certain chronic pain conditions, depression, and OCD. The investigators would like to evaluate the impact of rTMS on the patient's overall perception of change, particularly on the clinical symptoms of motor FND. Secondary objectives include evaluating the overall effect on symptoms from the clinician's perspective, the effect on quality of life, on depressive and anxiety symptoms and associated dissociation, as well as evaluating any changes in the sense of agency and identifying the side effects of rTMS treatment.
详细描述
Functional neurological disorder (FND) is a condition that causes significant suffering and disability, as well as considerable cost to society. It is defined by the presence of neurological symptoms that interfere with an individual's functioning and are not consistent with any known anatomical lesion. Motor FNDs, i.e., those with motor neurological symptoms, are the best defined. In recent years, much progress has been made in terms of recognition, diagnosis, and medical care. However, in terms of treatment, the options remain limited.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and acceptable treatment that has proven effective in certain chronic pain conditions, depression, and OCD. It involves applying repeated magnetic pulses to a specific area of the brain in order to modify the electrical current in the concerned area and the connectivity of associated regions. Several studies have shown the effectiveness of this therapy in patients with FND, although discrepancies remain, particularly in the neuroanatomical target and evaluation criteria.
Recent advances in neuroimaging of FNDs have led to a better understanding of the pathophysiology of FNDs and have resulted in certain recommendations for the clinical evaluation of FNDs in research. The most widely shared theoretical model of motor FNDs is that of movement prediction. It suggests a predominant role for the right temporo-parietal junction (rTPJ) in FNDs.
From a neuroimaging perspective, Voon et al. demonstrated in 2010 that eight subjects with functional tremors exhibited hypoactivity in the rTPJ. This area of the brain appears to be strongly involved in the sense of agency, yet this function is impaired in subjects with FND. A study of seven patients with FND of the dissociative functional seizure type showed a reduction in the number of seizures per week following 30 sessions of rTMS targeting the rTPJ at an excitatory frequency.
More recently, S. Aybek's team demonstrated a change in brain activity in the rTPJ in a fMRI in patients with FND after a session of theta burst (tb) rTMS. Theta burst stimulation allows for more effective stimulation in a shorter time. The intermittent excitatory tb-rTMS protocol showed a tendency to increase the rTPJ activity. In this study, tolerance was evaluated as a secondary outcome measure. No adverse effects were reported other than asthenia and headaches, which are well-known and documented adverse effects of rTMS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients over 18
- •Patients with FND, either deficits or abnormal movements, diagnosed by a neurologist.
- •Patients with an indication for validated neuronavigated rTMS treatment.
- •Patients who have indicated that they do not object to participating in the study.
排除标准
- •Patients subject to legal protection (legal guardianship, conservatorship, trusteeship)
- •Patients deprived of liberty
结局指标
主要结局
Difference in PGIC (Patient Global Impression of Change) score before versus after treatment.
时间窗: From enrollment to the end of the data collecting process : 1 month and 3 weeks
The aim is to measure the impact of a course of thetaburst rTMS targeting the rTPJ on the patient's overall impression of change. 5 days before the treatment patients are assessed for all aspects of patients' health using the PGIC. Patients take the test again on the last day of the treatment and again one month after the end of treatment. Score ranges from 1 to 7, the bigger the score, the better the change is.
次要结局
- Difference in CGI-I (Clinical Global Impressions - Improvement) score before versus after treatment(From enrollment to end of data collecting : 1 month and 3 weeks)
- Difference in CGI-Severity (CGI-S) score before versus after treatment.(From enrollment to the end of the data collecting process : about three months)
- Difference in Simplified-functional movement disorder rating scale (S-FMDRS) score before versus after treatment(From enrollment to the end of the data collecting process : about three months)
- Difference in MADRS (Montgomery-Asberg Depression Rating Scale) score before versus after treatment(From enrollment to the end of the data collecting process : about three months)
- Difference in Fatigue Severity Scale (FSS) score before versus after treatment(From enrollment to the end of the data collecting process : about three months)
- Difference in the Dissociative Experience Scale score before versus after treatment.(From enrollment to the end of the data collecting process : 1 month and 3 weeks)
- Difference in Hospital Anxiety and Depression (HAD) score before versus after treatment.(From enrollment to the end of the data collecting process : 1 month and 3 weeks)
- Difference in the French version of the Sense of Agency Scale (F-SoAS) score before versus after treatment.(From enrollment to the end of the data collecting process : 1 month and 3 weeks)
- Difference in the 36-Item Short Form Health Survey (SF-36) score before versus after treatment.(From enrollment to the end of the data collecting process : 1 month and 3 weeks)
- Difference in PGIC score throughout the treatment process.(From enrollment to the end of the data collecting process : 1 month and 3 weeks)
- Evaluation of the side effects of rTMS(From enrollment to the end of the data collecting process : 1 month and 3 weeks)
- Difference in PGIC (Patients' global impressions of change) score throughout the treatment process.(From enrollment to the end of the data collecting process : 1 month and 3 weeks)