Comparison between objective effect and subjectively perceived improvement of symptoms in patients with focal dystonia six weeks after botulinum toxin therapy.

• Conditions: G24.5; Spasmodic torticollis; Blepharospasm; G24.3

• Registration Number: DRKS00025046
• Lead Sponsor: Klinik für Neurologie Universitätsklinik Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Good general condition
- Diagnosis of cervical dystonia and/or diagnosis of blepharospasm.
- Existing botulinum toxin therapy at regular intervals
- Voluntary participation
- Written consent

Exclusion Criteria

- Simultaneous presence of other serious neurological or psychiatric diseases (e.g. epilepsy, multiple sclerosis, schizophrenia, addiction, etc.).
- Doubts about the capacity to consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(a) Absolute and percentage improvement in objectifiable dystonic symptoms between the two examination dates in terms of TSUI and TWISTRS score (in patients with cervical dystonia) or JRS (in patients with blepharospasm).

Secondary Outcome Measures

Name	Time	Method
(b) Absolute and percentage subjective improvement of dystonic symptoms as measured by the CDQ-24 and visual analog scales (subjective severity of dystonia, pain perception, subjective assessment of the effect of therapy, and therapy satisfaction).<br><br>(c) Determination of the difference in percent objective and subjective improvement. Calculation of the simple correlation as well as the intraclass correlation coefficient (ICC) between the variables mentioned in (a) and (b).<br><br>(d) Determination of the dependence of the variables mentioned in (b) and (c) on the degree of depressiveness (measured by the BDI) as well as social stigma (measured by the LSAD). Predicting the objective therapeutic effect from the subjective assessment (and vice versa), taking into account depressiveness and social stigma.