Functional Neurological Disorder
Conditions
Keywords
Functional Neurological Disorder, Emotional dysregulation, Autonomic nervous system, Endophenotypes, Biofeedback of Heart Rate Variability, Transdiagnostic approach
Brief summary
Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.
Detailed description
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. Firstly, patients with FND will prospectively undergo an comprehensive clinical evaluation considering symptoms, functional capacity, quality of life, and an assessment of the physical and psychological comorbidities. Then patients will complete an emotional task and undergo multimodal autonomic measures. Cluster analyses will be conducted to identify both dysfunctional and functional autonomic profiles associated with the clinical exploration, enabling confirmation of the endophenotypes hypothesis and allowing for specific characterization of the profils. The clinical evaluation of the beneficial effects of HRV BFB will rely on repeated mesures of symptoms, functional capacity, and quality of life at scheduled points in time before and after the both interventions (HRV-BFB and pseudo-BFB). The emotional task and autonomic measures will be repeated simultaneously.
Interventions
Biofeedback (BFB), sometimes referred to as "biological feedback technique," is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as well as emotional states. HRV-BFB has been clinically and experimentally validated as a physiological intervention and has demonstrated its effectiveness. However, it has never been studied in an adult FND population.
OTHERPseudo HRV-BFB
The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Laboratoire de Psychologie et NeuroCognition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
This study consists of 5 visits (V1, V2, V3, V4, V5). At V1, participants will be randomized into two groups: HRV-BFB (experimental group) or Pseudo HRV-BFB (control group). Participants will remain single-blinded after randomization. Depending on the assigned group, participants will practice one specific intervention during the first 30-day period (V1-V2). At V2, participants will switch to the other arm and practice the second intervention during the second 30-day period (V2-V3). At V3, both interventions will end, and participants will be unblinded and encouraged to continue HRV-BFB at home. Clinical evaluation will be repeated 5 times at day 1 (V1), days 30 +/- 10 (V2), days 60 +/- 10 (V2), 6 months (V4) and 1 year (V5). The research team will exercise extreme caution to ensure consistent instructions and feedback, minimizing biases associated with lack of double-blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Clinical Global Impression Score | Day 1 (V1) | 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 | Day 1 (V1) | 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 | Day 1 (V1) | 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 | Day 1 (V1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other physical symptoms score | Day 1 (V1) | The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. |
| Depressive symptoms score | Day 1 (V1) | The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. |
| Trait anxiety score | Day 1 (V1) | The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. |
| Quality of sleep measure | Day 1 (V1) | The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. |
| Dissociative Experiences | Day 1 (V1) | The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. |
| Alexithymia score | Day 1 (V1) | Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items. |
| Brief Illness Perception score | Day 1 (V1) | Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. |
| Emotion Regulation Profile | Day 1 (V1) | The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. |
| Childhood Trauma profile | Day 1 (V1) | The Childhood Trauma profile will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Frenc version Paquette et al., 2004). This scale includes 28 items. |
| Positive Affect and Negative Affects | Day 1 (V1) before the emotional induction task | The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. |
| High Frequency [HF] (>0.15 Hz) | Day 1 (V1) | High Frequency (\>0.15 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 \[HRV\]. |
| Root Mean Square of Successive Differences [RMSSD] | Day 1 (V1) | Root Mean Square of Successive Differences, Frequency-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 \[HRV\]. |
| Skin conductance responses [SCR] frequency | Day 1 (V1) | Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). |
| Skin conductance responses [SCR] amplitude | Day 1 (V1) | Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). |
| Delta frequency (0-4Hz) | Day 1 (V1) | Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. |
| Theta frequency (4-7Hz) | Day 1 (V1) | Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. |
| Alpha frequency (8-12Hz) | Day 1 (V1) | Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. |
| Beta frequency (13-30Hz) | Day 1 (V1) | Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. |
| Gamma frequency (>30Hz) | Day 1 (V1) | Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORDang Khoa Nguyen
Université de Montréal's affiliated hospital research centre
Outcome results
None listed