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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025046

Enrollment

Registered

2021-05-03

Start date

2021-06-01

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

G24.3 G24.5

Interventions

Group 1: Patients with focal dystonia (blepharospasm, cervical dystonia) under therapy with botulinum toxin, 2 examination appointments (each before and 6 weeks after botulinum toxin injection)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
(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

Measure	Time frame
(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). (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). (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.	—

Measure

Time frame

(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). (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). (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.

—

Countries

Germany

Contacts

Public ContactSimon Baudrexel

Klinik für Neurologie Universitätsklinikum Frankfurt

simon.baudrexel@kgu.de069 6301 7468

Outcome results

None listed

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