Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Root mean square of successive RR interval differences [RMSSD]
研究概览
简要总结
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.
详细描述
Somatoform disorders [SD] are defined as physiological function or organ disturbances unexplained by a specific diagnosis criterion. Some approaches have recently defended the idea of common factors of vulnerability behind the large variability of the clinical symptoms regarding the SD. In this context, the lead of the neurovegetative disturbances started receiving attention following some studies that suggested the autonomic nervous system [ANS] disturbances concerning a somatoform disorder, independently of its form. Two different neurovegetative endophenotypes (individual autonomic profiles) were highlighted: a functional neurovegetative profile (high vagal tone) and a dysfunctional neurovegetative profile (low vagal tone).
A dysfunctional neurovegetative profile could be accompanied by a chronic decoupling in the brain-visceral axis according as the ANS is considered as a bidirectional communication system linked the central nervous system [CNS] and the viscera. Depending on the types of the neurovegetative profiles, different degrees of cognitive-emotional vulnerability and a higher or a lower level of acceptance of the illness could be supposed. Finally, recent findings defend the idea of the traumatic experiences as a determining factor to develop a SD.
In accordance to the last notions regarding the SD, some therapeutic approaches could be interesting specifically techniques focusing on the vagal nerve. In this context, biofeedback [BFB] could provide a powerful method to restore the clinical and physiological impairments.
As a consequence, the main objective is to evaluate the physiological and clinical effects of the BFB training with patients suffering from SD: Irritable Bowel Syndrome [IBS] or Psychogenic Non Epileptic Seizure [PNES]. The investigators make the prediction that the patients will be more or less responding to the biofeedback depending on their neurovegetative profile. A clustering will be performed in advance to identify the patients having a dysfunctional neurovegetative profile and patients having a functional neurovegetative profile. It will also permit to the investigators to confirm the hypothesis about the existence of two neurovegetative profiles related to a visceral-brain decoupling concerning the SD, independently of its form. To attest to it, 2 types of somatoform disorders will be analyzed: the irritable bowel syndrome manifesting by peripheral symptoms and the psychogenic non-epileptic seizures manifesting by central symptoms. Then the investigators will carry out a psycho-social exploration to demonstrate a higher cognitive-emotional vulnerability and a higher traumatic event incidence in this particular population, depending on their autonomic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 session (T3) 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
- •Somatoform disorders (IBS or PNES) diagnosis must be established by the partner doctors
- •Participants must have home computer
- •Participants must be of the age of majority
- •Participants must be registered for social security
- •Participants must have signed an informed consent
排除标准
- •Specially protected participants (under clauses L1121-5 and L1121-8 by the code of public health): juveniles, pregnant womens, nursing mothers, law's protection peoples
- •Participants suffering from a severe psychiatric disease needing specialised attention
- •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
- •Participants were compensated more than 4500 euros because of his research protocol participation concerning human over the 12 months prior to the actual study
- •Participants being not be able to contact in emergency
- •Participants being in an exclusion period from another study
结局指标
主要结局
Root mean square of successive RR interval differences [RMSSD]
时间窗: Up to 52 days from T1 (T3)
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
High frequency [HF] (0.15-0.40 Hz)
时间窗: Up to 52 days from T1 (T3)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
次要结局
- Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)(Up to 52 days from T1 (T3))
- Gamma frequency (>30Hz)(Up to 52 days from T1 (T3))
- Integrated skin conductance responses [ISCR](Up to 52 days from T1 (T3))
- Standard deviation of all NN intervals [SDNN](Up to 52 days from T1 (T3))
- Pulsatility index variation [PI](Up to 52 days from T1 (T3))
- Low frequency [LF] (0.04-0.15 Hz)(Up to 52 days from T1 (T3))
- Total power (0-0.40 Hz)(Up to 52 days from T1 (T3))
- Breathing rate(Up to 52 days from T1 (T3))
- Ratio Low frequency / High frequency [LF / HF](Up to 52 days from T1 (T3))
- Skin conductance responses [SCR] frequency(Up to 52 days from T1 (T3))
- Dominant power (0-0.15Hz)(Up to 52 days from T1 (T3))
- Total power (0-0.15Hz)(Up to 52 days from T1 (T3))
- Alpha frequency (8-12Hz)(Up to 52 days from T1 (T3))
- Alexithymia score(Up to 16 days from T2)
- Neuroticism score(Up to 16 days from T1)
- Trait and state anxiety scores(Up to 8 days from T1)
- Perceived-stress level(Up to 52 days from T1 (T3))
- Coping flexibility(Up to 52 days from T1 (T3))
- Skin conductance responses [SCR] amplitude(Up to 52 days from T1 (T3))
- Slow-waves frequency (physiological outcome)(Up to 52 days from T1 (T3))
- Style of coping(Up to 16 days from T1)
- Life satisfaction score(Up to 52 days from T1 (T3))
- Frequency, severity and intensity scores(Up to 8 days from T2)
- Delta frequency (0-4Hz)(Up to 52 days from T1 (T3))
- Positive affectivity score(Up to 52 days from T1 (T3))
- Interceptive sensitivity score(Up to 8 days from T1)
- Acceptance score(Up to 52 days from T1 (T3))
- Theta frequency (4-7Hz)(Up to 52 days from T1 (T3))
- Beta frequency (13-30Hz)(Up to 52 days from T1 (T3))
- Social support score(Up to 8 days from T1)
- Depressive symptoms score(Up to 52 days from T1 (T3))
- Metacoping(Up to 52 days from T1 (T3))
- Negative impact scores(Up to 16 days from T2)
- Child Abuse scores(Up to 16 days from T1)
研究者
Essaiclinique_BIOFEESOMATO
Pr. Bruno Bonaz
University Hospital, Grenoble
