DRKS00030196Recruiting未知
Emotion processing in functional voice disorders - BRAVO2
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Bonn0 sites80 target enrollmentStarted: September 12, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
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:
- •oSymptomatic patients with ICD-10 F44.4 dissociative movement disorders diagnosis with acute (< 6 months present) or chronic symptoms (> 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
- •oAsymptomatic participants with a history of ICD-10 F44.4 dissociative movement disorders diagnosis with acute (< 6 months present) or chronic symptoms (> 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 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 (< 10 Vocal Fatigue Index)
- •o Past voice therapy
- •o History of trauma or surgery on the larynx including thyroid gland
- •o Acute respiratory infections or symptoms, e.g., from colds, allergies, asthma, or reflux, that impact the voice
- •o Smoking (past 5 years)
- •o Depression per BDI-II > 14
- +1 more not shown
Investigators
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