Functional Dystonia (Disorder)HYPNODYSNCT05179811
Description of the Evolution of Functional Dysphonia Managed by Hypnotherapy
An observational study of Functional Dystonia (Disorder), run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
HYPNODYS is a single-center study evaluating the evolution of perceived voice-related disability before and after 3 standardized hypnosis sessions in patients with functional dysphonia. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Functional Dystonia (Disorder)
- What is being tested?
- Hypnosis sessions
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2022to 6 Oct 2023
- Phase
- Observational
- 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 95 years
- All sexes
- Adult, Older adult
Study population: Patients with functional dysphonia using the Voice Handicap Index score
Who may be able to join
- Diagnosis of functional neurological disorder according to the DSM-5
- Supported at the Rothschild Foundation as part of a hypnotherapy protocol
- Mastering the understanding of the French language
- Express consent to participate in the study
Who cannot join
- Organic etiology of dysphonia
- Decompensation of a psychiatric pathology
- Discovery during study of an organic etiology not initially identified
Trial locations and contacts
1 site in 1 country.
About this study
HYPNODYS is a single-center study evaluating the evolution of perceived voice-related disability before and after 3 standardized hypnosis sessions in patients with functional dysphonia.
Read the detailed description
Functional or psychogenic voice and speech disorders are characterized by various changes in voice (aphonia or dysphonia) or speech (stuttering, foreign accent syndrome, and childish prosody in adults) without organic damage associated. These disorders have a significant functional impact (physical and mental handicap) and a significant cost for society.
Their management, like that of functional neurological disorders in general, is still poorly codified. Different therapeutic strategies are mentioned, especially in the event of speech therapy failure, in particular behavioural and cognitive psychotherapeutic approaches.
The recent explanatory hypotheses of functional neurological disorders are that the processing of sensory and motor information can be modulated, or even inhibited, by cognitive and attentional mechanisms. Different elements (volition, emotions, attention) can exclude certain psychic representations from consciousness.
Hypnosis, by exercising direct control over attentional resources makes it possible to obtain hypoactivation of the medial prefrontal cortex and hyperactivation of the executive and salience networks, making greater use of the buffer of working memory and activate the para-sympathetic system. Thus, one can observe analgesia, amnesia, a loss of the notion of time, plurimodal hallucinations, a detachment from oneself, a distortion of reality and logic.
Hypnosis has been used since the 19th century in the treatment of functional paralysis. To date, there are only presentations and case series evaluating the value of hypnosis in functional disorders of voice and speech. However, from a clinical standpoint, the use of hypnosis seems to show a significant interest in functional speech disorders.
Functional neurological disorders are located at the crossroads of neurological and psychiatric disorders, psychiatric and psychological evaluation of these patients therefore seems necessary in order to measure their impact on the pathological and recovery processes through hypnotherapy.
- Conditions
- Functional Dystonia (Disorder)
- Being tested
- Hypnosis sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionsProcedure or surgery
- Physical examination
- Psychiatric Assessment
- VHI, SF-36, IPQ-R questionnaires
- Standardized voice recording
- 3 Standardized Hypnotherapy sessions
- CGI-I-Patient Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients with functional dysphonia using the Voice Handicap Index score. Receives: Procedure: Hypnosis sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of perceived voice related disability before and after 3 standardized hypnosis sessions
Description of this evolution using the Voice Handicap Index score VHI.The questionnaire items were grouped into three equal parts which represent three aspects of voice disorders: functional, emotional and physical. The Voice Handicap Index consists of 30 items, or 10 items per game. The questionnaire is completed item by item by choosing one of the following five answers according to frequency: never, almost never, sometimes, almost always and always.The scores assigned to the answers range from zero to four points, knowing that never is zero and always is worth. The average of the total score at VHI obtained by so called normal subjects, without voice disturbance, is 6.86. A subject obtaining a score equal or less than 6.86 does not present a vocal handicap. A score greater than or equal to 26.62 is pathological
Measured: day 0 and 3 months after last hypnosis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start8 Apr 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Why it stopped: lack of recrutement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Dystonia (Disorder)Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Cécile HUBSCH, Principal investigator, Hôpital Fondation A. de RothschildStéphane MOUCHABAC, Study director, Hôpital Saint-Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179811
- Sponsor's protocol ID
- CHH_2021_22
- Acronym
- HYPNODYS
- Status last verified
- Jun 2024
- First submitted
- 10 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Evolution of Functional Dysphonia Managed by Hypnotherapy
- ClinicalTrials.gov ID
- NCT05179811
- Acronym / sponsor ID
- HYPNODYS / CHH_2021_22
- Conditions
- Functional Dystonia (Disorder)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recrutement
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 5 Jan 2022 (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.
HYPNODYS is a single-center study evaluating the evolution of perceived voice-related disability before and after 3 standardized hypnosis sessions in patients with functional dysphonia.
Detailed description
Functional or psychogenic voice and speech disorders are characterized by various changes in voice (aphonia or dysphonia) or speech (stuttering, foreign accent syndrome, and childish prosody in adults) without organic damage associated. These disorders have a significant functional impact (physical and mental handicap) and a significant cost for society.
Their management, like that of functional neurological disorders in general, is still poorly codified. Different therapeutic strategies are mentioned, especially in the event of speech therapy failure, in particular behavioural and cognitive psychotherapeutic approaches.
The recent explanatory hypotheses of functional neurological disorders are that the processing of sensory and motor information can be modulated, or even inhibited, by cognitive and attentional mechanisms. Different elements (volition, emotions, attention) can exclude certain psychic representations from consciousness.
Hypnosis, by exercising direct control over attentional resources makes it possible to obtain hypoactivation of the medial prefrontal cortex and hyperactivation of the executive and salience networks, making greater use of the buffer of working memory and activate the para-sympathetic system. Thus, one can observe analgesia, amnesia, a loss of the notion of time, plurimodal hallucinations, a detachment from oneself, a distortion of reality and logic.
Hypnosis has been used since the 19th century in the treatment of functional paralysis. To date, there are only presentations and case series evaluating the value of hypnosis in functional disorders of voice and speech. However, from a clinical standpoint, the use of hypnosis seems to show a significant interest in functional speech disorders.
Functional neurological disorders are located at the crossroads of neurological and psychiatric disorders, psychiatric and psychological evaluation of these patients therefore seems necessary in order to measure their impact on the pathological and recovery processes through hypnotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: Hypnosis sessionsPatients with functional dysphonia using the Voice Handicap Index score. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with functional dysphonia using the Voice Handicap Index score
Key inclusion criteria (4 listed)
- Diagnosis of functional neurological disorder according to the DSM-5
- Supported at the Rothschild Foundation as part of a hypnotherapy protocol
- Mastering the understanding of the French language
- Express consent to participate in the study
Key exclusion criteria (3 listed)
- Organic etiology of dysphonia
- Decompensation of a psychiatric pathology
- Discovery during study of an organic etiology not initially identified
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 |
|---|---|---|
| Hypnosis sessions* Physical examination * Psychiatric Assessment * VHI, SF-36, IPQ-R questionnaires * Standardized voice recording * 3 Standardized Hypnotherapy sessions * CGI-I-Patient Questionnaire | Procedure or surgery | Cohort |
Primary outcome
Evolution of perceived voice related disability before and after 3 standardized hypnosis sessions
Time frame: day 0 and 3 months after last hypnosis session
Description of this evolution using the Voice Handicap Index score VHI.The questionnaire items were grouped into three equal parts which represent three aspects of voice disorders: functional, emotional and physical. The Voice Handicap Index consists of 30 items, or 10 items per game. The questionnaire is completed item by item by choosing one of the following five answers according to frequency: never, almost never, sometimes, almost always and always.The scores assigned to the answers range from zero to four points, knowing that never is zero and always is worth. The average of the total score at VHI obtained by so called normal subjects, without voice disturbance, is 6.86. A subject obtaining a score equal or less than 6.86 does not present a vocal handicap. A score greater than or equal to 26.62 is pathological
Results and safety
The study was stopped early (reason given: lack of recrutement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Related trials for Functional Dystonia (Disorder)
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Active, not recruitingPhase 4
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
Dystonic Tremor Syndrome
Recruiting
Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia
Laryngeal Dystonia
Recruiting
Effects of Neuromodulation in Laryngeal Dystonia
Laryngeal Dystonia, Focal Dystonia
RecruitingObservational study
Observational Study on "Functional Overlay" in Patients With Movement Disorders
Conversion Disorder, Parkinson Disease
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.
Cécile HUBSCH principal investigator
Hôpital Fondation A. de Rothschild
Stéphane MOUCHABAC study director
Hôpital Saint-Antoine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dystonia (Disorder), run by Fondation Ophtalmologique Adolphe de Rothschild 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Jun 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?
The study was stopped early (reason given: lack of recrutement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of perceived voice related disability before and after 3 standardized hypnosis sessions (time frame: day 0 and 3 months after last hypnosis session). 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 4 Jun 2024.