Modulation of the Sense of Agency Across Different Neurological Disorders Using Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in objective Performance Agency Task (MBSR)
研究概览
简要总结
A conversion disorder is a dysfunction of the nervous system in which no structural damage can be demonstrated. However, it must be distinguished from other psychiatric disorders such as psychosis or depression. There are a variety of signs of the disease, such as muscle paralysis, uncontrolled tremors or cramps. In rarer cases, blindness, deafness or numbness may occur. Diagnosing this complex disorder has always been a challenge for neurologists and psychiatrists.
This study investigates the effects of transcranial magnetic stimulation (TMS) on the general well-being and symptoms of conversion disorder and other neurological disorders and in comparison to healthy subjects. The TMS method allows to target specific areas of the brain by means of magnetic fields. This technique is not painful and does not have long-lasting effects.
In addition, the study investigates the effects of mindfulness-based stress reduction on the general well-being and symptoms of conversion disorder and other neurological disorders and compared to healthy subjects. This technique is not painful and has no long-lasting effects.
Furthermore, the study examines movement patterns and symptoms of patients compared to healthy controls while they are in a virtual reality.
Finally, the study examines patients' brain activity while playing a game targeting the sense of agency in real time, which is recorded with an MRI scanner.
The study includes a maximum of twelve sessions in total (ten sessions of approximately 1.5-2 hours each and two sessions each overnight). The planned study methods include TMS, (real-time and normal) magnetic resonance tomography of the brain (MRI "tube"), virtual- and augmented reality (AR/VR), questionnaires, blood, saliva, and motion sensors (e.g., fitness bracelet), and participation in the 8-week mindfulness program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of a functional disorder (such as FND, GTS, PPD, anxiety or depression or others) according to DSM-5 diagnostic and ICD-11 criteria, or
- •A diagnosis of an organic neurological disorder such as stroke, multiple sclerosis (MS), neuromuscular, or movement disorder
- •Aged > 16 years old
- •Willing to participate in the study (by signing the ICF)
- •Capable of judgement
- •healthy controls:
- •Aged > 16 years old
- •Willing to participate in the study (by signing the ICF)
- •Capable of judgement
排除标准
- •Presence of comorbid psychiatric disorders such as psychosis, current major and severe depression episode, autistic spectrum disorder
- •Past surgery in the brain
- •History of alcohol or drug abuse
- •Botulinum toxin injection in last 3 month
- •Inability to follow the procedure of the study, e.g., due to language problems
- •For organic disorders only: Active severe aphasia, dementia, neglect and acute confusional state, severe pain
- •For female participants: breastfeeding, pregnancy or intention to become pregnant (assessed with standard urine test prior to the enrolment in the experiment and before each visit)
- •For MRI and TMS part only: Past surgery in the brain
- •For MRI and TMS part only: Implanted medical devices not-compatible with MRI or TMS (e.g., cochlear implants, infusion pumps, neurostimulators, cardiac pacemakers)
- •For TMS part only: History of actual or suspected epilepsy
- •For TMS part only: Suspected or diagnosed labile or hypertensive blood pressure
- •For Virtual Reality only: No cybersickness
结局指标
主要结局
Change in objective Performance Agency Task (MBSR)
时间窗: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4), visit 7 to 11 (12 - 16 weeks)
The objective performance on the behavioural tasks targeting the sense of agency using the score of an agency task played in the MRI scanner, on a computer or in Virtual Reality before and after a therapeutic intervention (mindfulness-based stress reduction, MBSR).The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game \[-\].
Change in subjective Performance Agency Task (TMS)
时间窗: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 7 to 11 (12 - 16 weeks)
The changes in objective and subjective performance on the behavioural tasks targeting the sense of agency using questionnaires before and after brain stimulation. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\].
Change in objective Performance Agency Task (TMS)
时间窗: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 7 to 11 (12 - 16 weeks)
The changes in objective performance on the behavioural tasks targeting the sense of agency using the score of an agency task played in the Magnetic Resonance Imaging (MRI) scanner, on a computer or in Virtual Reality before and after brain stimulation (transcranial magnetic stimulation, TMS). The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game \[-\].
Change in subjective Performance Agency Task (MBSR)
时间窗: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4), visit 7 to 11 (12 - 16 weeks)
The subjective performance on the behavioural tasks targeting the sense of agency using questionnaires before and after a therapeutic intervention (MBSR). Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\].
次要结局
- task-based fMRI measures TMS(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline))
- Subjective stress parameters pre/post(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- DTI measures TMS(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline))
- Neurological Examination TMS(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline))
- Neurological Examination MBSR(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- Sleep(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- Long-term effects on DTI measures MBSR(At follow-up (6 month after visit 5))
- Long-term effects on subjective agency MBSR(At follow-up (6 month after visit 5))
- task-based fMRI measures MBSR(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- resting-state fMRI measures MBSR(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- DTI measures MBSR(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- Objective stress parameters pre/post(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- resting-state fMRI measures TMS(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline))
- Subjective Agency TMS(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline))
- Long-term effects on subjective performance(At follow-up (6 month after visit 5))
- Neurophysiological measures: MEP(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5))
- Subjective Agency MBSR(Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4))
- Long-term effects on resting-state fMRI measures MBSR(At follow-up (6 month after visit 5))
- Long-term effects on objective performance(At follow-up (6 month after visit 5))
- Epigenetic profile(1st visit (baseline))
- Neurofeedback(Visit 7 to 11 (12 - 16 weeks))
- Neurophysiological measures: SICI(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5))
- Stability(Visit 1 (at baseline), and follow up (8 month after visit 1))
- Long-term effects on task-based fMRI measures MBSR(At follow-up (6 month after visit 5))
- Neurophysiological measures: MT(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5))
- Neurophysiological measures: PAS(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5))
- Long-term fluctuations of objective stress parameters(at follow-up (6 month after visit 5))
- Long-term fluctuations of subjective stress parameters(at follow-up (6 month after visit 5))
- Cognition(Visit 1 (at baseline), and follow up (8 month after visit 1))
- Long-term effects on neurological examination MBSR(At follow-up (6 month after visit 5))
- Kinematics of limb movements(at visit 6 (at least one week after visit 5))
- Pain processing(Visit 1 (at baseline), and follow up (8 month after visit 1))
- Neurophysiological measures: LICI(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5))
- Neurophysiological measures CSP(Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5))
- Position of focus of attention(at visit 6 (at least one week after visit 5))