Probing the Heart Rate Variability Biofeedback as an Innovative and Non-invasive Treatment for Functional Neurological Disorders Guided by a Multimodal Approach of Autonomic Nervous System.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Patient Clinical Global Impression Score
研究概览
简要总结
Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.
详细描述
Although Functional Neurological Disorders (FND) represent one of the most common reasons for consultation in Neurology, the pathological mechanisms remain unexplained. Recent studies suggest disrupted emotional processes in patients with FND and disturbed autonomic nervous system profiles, highligting the hypothesis of autonomic endophenotypes among the FND population.
The Heart Rate Variability Biofeedback (HRV-BFB) is an innovative and non-invasive approach, based on the self-regulation of autonomic physiological processes. It has shown promising results in clinical and non-clinical populations but has never been assessed in an adult FND population.
Therefore, this approach appears particularly promising for understanding the mechanisms underlying FND and developing personalized therapy.
The main objective is to investigate the clinical effects of HRV-BFB on FND patients compared to placebo in a single-blind crossover design.
The investigators predict that depending on their autonomic profile, patients will respond to HRV-BFB to varying degrees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participants won't be informed of the condition to which they belong. A debriefing will be done at the end of the last intervention (V3) for each participant.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional Neurological Disorders (FND) diagnosis must be medically established
- •Participants must have a smartphone (android ou Iphone)
- •Participants must be of the age of majority
- •Participants must have signed an informed consent
- •Sufficiently fluent in French to understand study documents and instructions
- •Consistency in performing repeated questionnaires
- •Normal or corrected-to-normal visual acuity
排除标准
- •Specially protected participants: juveniles, pregnant womens, nursing mothers, law's protection peoples
- •Participants suffering from a severe psychiatric disease needing specialised attention
- •History of severe neurosurgical pathology
- •Alcohol dependence or drug use
- •Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)
- •Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)
- •Participants placing under judicial or administrative supervisions
研究组 & 干预措施
Experimental group (HRV-BFB training)
Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV.
干预措施: Heart rate variability Biofeedback [HRV-BFB] (Other)
Placebo Control group (Pseudo HRV-BFB training)
Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV.
干预措施: Pseudo HRV-BFB (Other)
结局指标
主要结局
Patient Clinical Global Impression Score
时间窗: Up to 360 days from V1 (V5)
The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.
Clinician Clinical Global Impression Score
时间窗: Up to 360 days from V1 (V5)
The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items.
Quality of life Score
时间窗: Up to 360 days from V1 (V5)
The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.
Self-perception of Occupation Score
时间窗: Up to 360 days from V1 (V5)
The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.
次要结局
- Emotion Regulation Profile(Up to 360 days from V1 (V5))
- Trait anxiety score(Up to 360 days from V1 (V5))
- Depressive symptoms score(Up to 360 days from V1 (V5))
- Beta frequency (13-30Hz)(Up to 80 days from V1 (V3))
- Gamma frequency (>30Hz)(Up to 80 days from V1 (V3))
- Other physical symptoms score(Up to 360 days from V1 (V5))
- Alexithymia score(Day 1 (V1))
- Theta frequency (4-7Hz)(Up to 80 days from V1 (V3))
- Quality of sleep measure(Up to 360 days from V1 (V5))
- Dissociative Experiences(Up to 360 days from V1 (V5))
- Childhood Trauma profile(Day 1 (V1))
- Root Mean Square of Successive Differences [RMSSD](Up to 360 days from V1 (V5))
- Brief Illness Perception score(Up to 360 days from V1 (V5))
- Skin conductance responses [SCR] frequency(Up to 360 days from V1 (V5))
- Skin conductance responses [SCR] amplitude(Up to 360 days from V1 (V5))
- Delta frequency (0-4Hz)(Up to 80 days from V1 (V3))
- Positive Affect and Negative Affects(Up to 40 days from V1 (V2) after the emotional re-exposure task)
- High Frequency [HF] (>0.15 Hz)(Up to 360 days from V1 (V5))
- Alpha frequency (8-12Hz)(Up to 80 days from V1 (V3))