Psychogenic DystoniaECoDysNCT04777825
Heart Rate Variability Biofeedback Training in Psychogenic Disorders
A study testing Heart rate variability biofeedback training (Symbiocenter) and psychoeducation session in people with Psychogenic Dystonia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
To study whether Heart Rate Variability (HRV) biofeedback training can improve abnormal head posture and painful symptomatology in patients with "cervical dystonia" not selected for DBS after extensive screening in a specialized unit but diagnosed " dysfunctional ". Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psychogenic Dystonia
- What is being tested?
- Heart rate variability biofeedback training (Symbiocenter) and psychoeducation session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2021to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75
- Responding to somatoform disorder characteristics as described in ICD-10 (F45: "The onset of physical symptoms associated with an insistent medical quest, persisting despite repeated negative assessments and statements by physicians that the symptoms have no organic basis. If there is a genuine physical disorder, it does not account for the nature or severity of the symptoms, or the distress or concerns of the subject. The multidisciplinary team will determine whether or not the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"] is associated with the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"], selected by the multidisciplinary team after a phase 1 assessment.
- Patient benefiting from a social security scheme
Who cannot join
- Simulation identified with obvious search for secondary benefit according to the ICD-10 classification ( Z76.5 Simulator: Person pretending to be ill (with obvious motivation"), or DSM-V(V65.2)
- Any other specific PAT-specific CEP (botulinum toxin, psychotherapy and/or relaxation provided by a professional (CBT, ACT, Mindfulness, etc.)) scheduled within 6 months, with the exception of the usual analgesics (Tier I or II)Presenting significant cognitive impairment (MoCa test ≤ 24/30),
- Absence foreseeable at least 30% of the sessions,
- Lack of informed consent.
- Pregnancy or planned pregnancy during the study period, Pregnant or breastfeeding women
- Major protected by law or patient under guardianship or curatorship
- Participation in other ongoing research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier
Emily SANREY, MSc, 467337445 ext. +33, e-sanrey@chu-montpellier.fr
Valérie GIL, CTA, 467337464 ext. +33, v-gil@chu-montpellier.fr
About this study
Official title: Evaluation of the Effectiveness of a Heart Rate Variability Biofeedback Training in the Management of Dysfunctional (Somatoform) Disorders
To study whether Heart Rate Variability (HRV) biofeedback training can improve abnormal head posture and painful symptomatology in patients with "cervical dystonia" not selected for DBS after extensive screening in a specialized unit but diagnosed " dysfunctional ".
Patients of the respiratory coherence group will receive HRV biofeedback training for 12 sessions during a 6 months-period. The hypothesis is that this kind of physiological noninvasive therapy increasing coherence respiratory, will reduce pain and patient's complain about their psychogenic abnormal head posture. Improvement of anxiety, depression and quality of life are expected.
Read the detailed description
Patients presenting with an isolated abnormal head posture, first diagnosed as cervical dystonia, demonstrated in fact, after neurological screening, to be of psychogenic origine. These patients are not candidate for functional surgery and, furthermore, usually refuse psychotherapy leading them to medical nomadism. This study proposes to evaluate the efficacy of an innovative intervention program based on Heart Rate Variability (HRV) biofeedback that promotes self-regulatory skills in dysfunctional movement disorders (DMD) patients in order to improve their condition and symptomatology.
Heart rate is under the control of efferent sympathetic and vagal activities directed to the sinus node, which are modulated by central brain stem (vasomotor and respiratory centers) and peripheral oscillators (oscillation in arterial pressure and respiratory movements). Spectral analysis of HRV is a reliable quantitative method for analyzing the modulatory effects of neural mechanisms on the sinus node. Several biofeedback protocols and assistive electronic technologies, such as proposed by SymbioCenter©, exist to enhance increase HRV and synchronize respiration with the heart rhythm. HRV biofeedback training appears to be an opportunity in the patient's management in order of preventing medical overconsuming. It is offering a safe and non-pharmacological alternative approach managed by a multidisciplinary team in a functional neurosurgery unit. It is expected that developing respiratory coherence in these patients will improve their painful symptomatology.
- Conditions
- Psychogenic Dystonia
- Being tested
- Heart rate variability biofeedback training (Symbiocenter), psychoeducation session
- Keywords
- Cervical dystonia, Psychogenic disorder, Heart Rate Variability, Functional neurosurgery
- Medical subject headings
- Dystonic Disorders, Torticollis, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedback training (Symbiocenter)Other
12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training
psychoeducation sessionOther
Each patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications).
| Study group | Role | What they receive |
|---|---|---|
| HRV biofeedback training | Experimental | During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. This group of patients will also benefit from the HRV biofeedback training. Receives: Other: Heart rate variability biofeedback training (Symbiocenter); Other: psychoeducation session |
| control | Other | During the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. Receives: Other: psychoeducation session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of the cervical dystonia at 6 months
Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)
Measured: 6 months
Secondary outcomes (11)
Variability of the cervical dystonia at 3 months
Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)
Measured: 3 months
Quality of life assessment in cervical dystonia at 3 months
Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale
Measured: 3 months
Quality of life assessment in cervical dystonia at 6 months
Measured by the Craniocervical Dystonia Questionnaire (CDQ24) scale
Measured: 6 months
Quality of life assessment at 3 months
Measured by SF-36 scale
Measured: 3 months
Quality of life assessment at 6 months
Measured by SF-36 scale
Measured: 6 months
Assessment of the severity of depression at 3 month
Measured by Beck Depression Inventory (BDI-II) scale
Measured: 3 months
Assessment of the severity of depression at 6 month
Measured by the Beck Depression Inventory (BDI-II) scale
Measured: 6 months
Assessment of the anxiety at 3 month
Measured by the State-Trait Anxiety Inventory (STAI A \& B) scale
Measured: 3 months
Assessment of the anxiety at 6 month
Measured by the State-Trait Anxiety Inventory (STAI A \& B) scale
Measured: 6 months
satisfaction with the care
satisfaction's VAS
Measured: 6 months
medical nomadism index
The index of "presumed nomadism" is the difference between the number of different doctors consulted and the number of different specialties of these same doctors. Any patient whose index is ≥ 3 over a period of 6 months is presumed nomadic.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start30 Apr 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychogenic DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe COUBES, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777825
- Sponsor's protocol ID
- RECHMPL19_0346
- Acronym
- ECoDys
- Status last verified
- May 2024
- First submitted
- 8 Sep 2020
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Heart Rate Variability Biofeedback Training in the Management of Dysfunctional (Somatoform) Disorders
- ClinicalTrials.gov ID
- NCT04777825
- Acronym / sponsor ID
- ECoDys / RECHMPL19_0346
- Conditions
- Psychogenic Dystonia
- Keywords
- Cervical dystonia, Psychogenic disorder, Heart Rate Variability, Functional neurosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study whether Heart Rate Variability (HRV) biofeedback training can improve abnormal head posture and painful symptomatology in patients with "cervical dystonia" not selected for DBS after extensive screening in a specialized unit but diagnosed " dysfunctional ".
Patients of the respiratory coherence group will receive HRV biofeedback training for 12 sessions during a 6 months-period. The hypothesis is that this kind of physiological noninvasive therapy increasing coherence respiratory, will reduce pain and patient's complain about their psychogenic abnormal head posture. Improvement of anxiety, depression and quality of life are expected.
Detailed description
Patients presenting with an isolated abnormal head posture, first diagnosed as cervical dystonia, demonstrated in fact, after neurological screening, to be of psychogenic origine. These patients are not candidate for functional surgery and, furthermore, usually refuse psychotherapy leading them to medical nomadism. This study proposes to evaluate the efficacy of an innovative intervention program based on Heart Rate Variability (HRV) biofeedback that promotes self-regulatory skills in dysfunctional movement disorders (DMD) patients in order to improve their condition and symptomatology.
Heart rate is under the control of efferent sympathetic and vagal activities directed to the sinus node, which are modulated by central brain stem (vasomotor and respiratory centers) and peripheral oscillators (oscillation in arterial pressure and respiratory movements). Spectral analysis of HRV is a reliable quantitative method for analyzing the modulatory effects of neural mechanisms on the sinus node. Several biofeedback protocols and assistive electronic technologies, such as proposed by SymbioCenter©, exist to enhance increase HRV and synchronize respiration with the heart rhythm. HRV biofeedback training appears to be an opportunity in the patient's management in order of preventing medical overconsuming. It is offering a safe and non-pharmacological alternative approach managed by a multidisciplinary team in a functional neurosurgery unit. It is expected that developing respiratory coherence in these patients will improve their painful symptomatology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV biofeedback training | Experimental | Other: Heart rate variability biofeedback training (Symbiocenter), Other: psychoeducation sessionDuring the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. This group of patients will also benefit from the HRV biofeedback training. |
| control | Other | Other: psychoeducation sessionDuring the inclusion visit, all patients will benefit from a psychoeducation session supervised by the psychologist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75
- Responding to somatoform disorder characteristics as described in ICD-10 (F45: "The onset of physical symptoms associated with an insistent medical quest, persisting despite repeated negative assessments and statements by physicians that the symptoms have no organic basis. If there is a genuine physical disorder, it does not account for the nature or severity of the symptoms, or the distress or concerns of the subject. The multidisciplinary team will determine whether or not the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"] is associated with the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) [ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"], selected by the multidisciplinary team after a phase 1 assessment.
- Patient benefiting from a social security scheme
Key exclusion criteria (7 listed)
- Simulation identified with obvious search for secondary benefit according to the ICD-10 classification ( Z76.5 Simulator: Person pretending to be ill (with obvious motivation"), or DSM-V(V65.2)
- Any other specific PAT-specific CEP (botulinum toxin, psychotherapy and/or relaxation provided by a professional (CBT, ACT, Mindfulness, etc.)) scheduled within 6 months, with the exception of the usual analgesics (Tier I or II)Presenting significant cognitive impairment (MoCa test ≤ 24/30),
- Absence foreseeable at least 30% of the sessions,
- Lack of informed consent.
- Pregnancy or planned pregnancy during the study period, Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedback training (Symbiocenter)12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training | Other | HRV biofeedback training |
| psychoeducation sessionEach patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications). | Other | HRV biofeedback training, control |
Primary outcome
Variability of the cervical dystonia at 6 months
Time frame: 6 months
Measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale. The total score is 0 (better outcome) to 85 (worse outcome)
11 secondary outcomes
Variability of the cervical dystonia at 3 months
Time frame: 3 months
Quality of life assessment in cervical dystonia at 3 months
Time frame: 3 months
Quality of life assessment in cervical dystonia at 6 months
Time frame: 6 months
Quality of life assessment at 3 months
Time frame: 3 months
Quality of life assessment at 6 months
Time frame: 6 months
Assessment of the severity of depression at 3 month
Time frame: 3 months
Assessment of the severity of depression at 6 month
Time frame: 6 months
Assessment of the anxiety at 3 month
Time frame: 3 months
Assessment of the anxiety at 6 month
Time frame: 6 months
satisfaction with the care
Time frame: 6 months
medical nomadism index
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe COUBES, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback training (Symbiocenter) and psychoeducation session in people with Psychogenic Dystonia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily SANREY, MSc (467337445 ext. +33, e-sanrey@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of the cervical dystonia at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.