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Emotion processing in functional voice disorders

Emotion processing in functional voice disorders - BRAVO2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030196
Enrollment
80
Registered
2022-09-12
Start date
2022-10-12
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F44.4 R49

Interventions

first MRI session (resting state network, ratings of pictures, anatomical scan)
after that voice treatment "laryngeal reposturing, circumlaryngeal massage"
Study time point 2: if the voice is restored, then second MRI session on same day
Group 1: Patients with acute or chronic functional aphonia or functional dysphonia. Study information and consent
Check of inclusion and exclusion criteria
Study time point 1 (same day): Completion of questionnaires on vocal function, personality, and risk factors
if not, continued voice therapy until voice is restored followed by second MRI session again with saliva and blood sampling, questionnaires on vocal function, and MRI protocol from study time point 1
Study time point 3: Follow-up after approximately 2 weeks with procedures as for study time point 2. To assess state mood prior to and after the MRI sessions, the Positive and Negative Affect Schedule
Study time point 1 (same day, if possible): Completion of questionnaires on vocal function, personality, and risk factors
after that voice intervention "laryngeal reposturing, circumlaryngeal massage"
Study time point 2 (same day): Saliva and blood sampling, questionnaires on vocal function, and MRI protocol from study time point 1
Study time point 3: Follow-up after approximately 2 weeks with procedures as for study time point 2. Um die aktuelle Stimmung vor und nach der MRT-Messung zu erfassen, wird der Positive and Negative A

Sponsors

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Bonn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with acute or chronic functional aphonia or dysphonia, asymptomatic participants with a history of acute or chronic functional aphonia or dysphonia and control participants with normal voice matched on age, gender, education, and handedness. Vocal status will be determined by phoniatric diagnostics or screening. Specific clinical inclusion criteria: o Symptomatic patients with ICD-10 F44.4 dissociative movement disorders diagnosis with acute ( 6 months present) in the sense of a psychogenic dysphonia or aphonia respectively intermittent aphonia. Alternative diagnoses are ICD-10 R49.0 or R48.8 dysphonia or 49.1 aphonia with organic and neurological voice disorders excluded and a tentative diagnosis of functional dysphonia or aphonia o Asymptomatic participants with a history of ICD-10 F44.4 dissociative movement disorders diagnosis with acute ( 6 months present) in the sense of psychogenic dysphonia or aphonia respectively intermittent aphonia. Alternative former diagnoses are ICD-10 R49.0 or R48.8 dysphonia or 49.1 aphonia with organic and neurological voice disorders excluded and a tentative diagnosis of functional dysphonia or aphonia

Exclusion criteria

Exclusion criteria: Exclusion criteria for clinical groups: o Certain infection and parasitic diseases (ICD-10 A00-B99), o malignant neoplasms (ICD-10 C00-C97), o organic, including symptomatic, mental disorders (ICD-10 F00-F09), o Mental and behavioral disorders due to psychoactive substance use (ICD-10 F10-F19), o Schizophrenia, schizotypal and delusional disorders (ICD-10 F20-F29), o Mental retardation (ICD-10 F70-F79), o Disorders of psychological development (ICD-10 F80-F89), o Systematic atrophies primarily affecting the central nervous system (ICD-10 G10-G14), o Other degenerative diseases of the nervous system (ICD-10 G30-G32), o Cerebrovascular diseases (ICD-10 I60-I69), o Pregnancy, childbirth and the puerperium (ICD-10 O00-O99). General exclusion criteria: o Missing capacity to consent o Acute suicidal intentions o Past brain surgery o Organic changes of the vocal folds (z. B. vocal fold nodules, phonotraumatic changes of the vocal folds), neurological causes of the voice disorder (in particular vocal fold paralysis) or history of trauma or surgery on the larynx including thyroid gland. Comorbidity of a functional voice disorder with laryngeal dystonia/spasmodic dysphonia (J38.3) or Vocal Cord Dysfunction (J38.5) is not an exclusion criterion since psychological factors may affect these voice disorders. o Contraindications to MRI (e.g., metal in the body). Exclusion criteria control group: o Antiepileptic or psychotropic medications o Current or past diagnoses in the following categories: o Certain infection and parasitic diseases (ICD-10 A00-B99), o Intestinal infectious diseases (ICD-10 A00-A09), o malignant neoplasms (ICD-10 C00-C97), o Inflammatory diseases of the central nervous system (ICD-10 G00-G09), o Extrapyramidal and movement disorders (ICD-10 G20-G26), o Episodic and paroxysmal disorders (ICD-10 G40-G47) o Symptoms and signs involving the nervous and musculoskeletal systems (ICD-10 R25-R29), o Mood (affective) disorders (ICD-10 F30-F39), o Neurotic, stress-related and somatoform disorders (ICD-10 F40-F48), o Disorders of adult personality and behavior (ICD-10 F60-F69) o Behavioral and emotional disorders with onset usually occurring in childhood and adolescence (F90-F98), o organic, including symptomatic, mental disorders (ICD-10 F00-F09), o Mental and behavioral disorders due to psychoactive substance use (ICD-10 F10-F19), o Schizophrenia, schizotypal and delusional disorders (ICD-10 F20-F29), o Mental retardation (ICD-10 F70-F79), o Disorders of psychological development (ICD-10 F80-F89), o Systematic atrophies primarily affecting the central nervous system (ICD-10 G10-G14), o Other degenerative diseases of the nervous system (ICD-10 G30-G32), o Cerebrovascular diseases (ICD-10 I60-I69), o Syncope and collapse (ICD-10 R55), o Other and unspecified convulsions (ICD-10 R56.8), o Pregnancy, childbirth and the puerperium (ICD-10 O00-O99). o Acute voice problems (e.g., hoarseness) or a diagnosis or an organic or functional voice disorders in the past (self-report) o Vocal fatigue ( 14 o Alexithymia per TAS-20 > 61

Design outcomes

Primary

MeasureTime frame
Voice quality of life (raw data, Voice Handicap Index, VHI, study session 1,2,3) Vocal fatigue (raw data, Vocal Fatigue Index, VFI, study session 1,2,3) Vocal tract discomfort (raw data, Vokaltrakt-Beschwerden Skala, VTD, study session 1,2,3) MRI activation in regions of interest (BOLD area 4p, SMA, ACC, MCC, Amygdala, PAG, OFC, precuneus, striatum, cerebellum, lingual/fusiform gyrus, angular gyrus in mean %, functional connectivity mPFC und amygdala) for tasks with varying emotional valence (study session 1,2,3) Saliva and blook to measure candidate genes (Studientermin 1,2,3)

Secondary

MeasureTime frame
(all study session 1) Personality (T-scores, Multidimensional Personality Questionnaire, MPQ) Personality social anxiety (raw data, Liebowitz Social Anxiety Scale) Personality self-esteem (raw data, Rosenberg self-esteem scale) Personality perfectionism (raw data, Frost Multidimensional Perfectionism Scale – Deutsch, FMPS-D) Behavioral inhibition and activation (raw data, BIS/BAS scales) Stress/life events (T-scores, Trier Inventory of Chronic Stress, TICS; raw data, Life Events Checklist, LEC-5) Dissociation (raw data, Fragebogen zu dissoziativen Symptomen, FDS) Emotion regulation and anxiety symptoms (raw data, State-Trait-Angstinventar, STAI; Affective Style Questionnaire, ASQ; Emotionsregulations-Inventar, ERI) Handedness (raw data, Edinburgh Händigkeitsfragebogen, EHI) Additional questionnaires regarding risk factors (all study session 1 or 2) Fragebogen zur Persönlichkeit bei zerebralen Erkrankungen, FPZ Borderline Symptom Liste Kurzversion, BSL-23 Fünf-Faktoren-Inventar, NEO-FFI Childhood Trauma Questionnaire, CTQ Clinician Administered PTSD Scale, CAPS Posttraumatic Stress Disorder Checklist, PCL-5 Cambridge Depersonalisation Scale, CDS (FDS) State-Trait-Ärgerausdrucks-Inventar, STAXI Wender Utah Rating Scale, WURS-k ADHS-Selbstbeurteilungsskala, ADHS-SB Somatic Symptom Scale 8, SSS-8 Mehrfach-Wortschatz-Intelligenztest, MWT-B Fragebogen zur Ursachenaufklärung von FNEA Soziodemographie

Countries

Germany

Contacts

Public ContactKatrin Blum

Medizinische Fakultät, Universität Bonn

s4kablum@uni-bonn.de0228-287-31064

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026