How botulinum toxin treatment affects people with involuntary neck movements (cervical dystonia)

Comprehensive assessment of patients with cervical dystonia treated with botulinum toxin, including neurological examination, functional and neurophysiological tests, radiological findings, serum biochemical concentrations, and neuropsychological tests

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11389213

Enrollment

100

Registered

2025-10-22

Start date

2023-07-26

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Idiopathic cervical dystonia Nervous System Diseases

Interventions

The study will involve patients with cervical dystonia receiving standard injection therapy as part of the National Health Fund (NHF) treatment program. Based on available documentation collected in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Ability to provide written informed consent 2. Adults (18–75 years) diagnosed with idiopathic cervical dystonia 3.Eligible for botulinum toxin type A treatment

Exclusion criteria

Exclusion criteria: 1. Secondary or symptomatic dystonia 2. Other neurological or psychiatric disorders 3. Recent medication changes affecting motor or cognitive function 4. Contraindications to botulinum toxin therapy

Design outcomes

Primary

Measure	Time frame
Measured before and after botulinum toxin administration: 1. Neuropsychological tests: 1.1. Cognitive function assessed using the Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), ACE-I EpiTrack 1.2. Anxiety disorders assessed using the Liebowitz Social Anxiety Scale 1.3. Depression assessed using the Beck Depression Scale 1.4. Pain assessed using the Numerical Rating Scale (NRS) 1.5. Sleep disorders assessed using the Epworth Sleep Scale 2. Functional assessment – mobility and posture examination: 2.1. Posturography: 2.1.1. Average displacement velocity (anteroposterior [AP] and mediolateral [ML]) 2.1.2. Path length 2.1.3. Romberg index 2.1.4. Root mean square (RMS) (AP and ML) 2.2. Up-And-Go Test 2.3. Tinetti test 3. Schellong test: 3.1. Systolic blood pressure (SBP) 3.2. Diastolic blood pressure (DBP) 3.3. Heart rate (HR) Measured during lying and standing position 4. Laboratory tests: S100 calcium-binding protein B (S100B molecule), neuron-specific enolase (NSE), occludin (OCLN), claudin-5 (CLN5), zonula occludens-1 (zo-1), sPECAM-1, sICAM-1, myoglobin, creatine kinase CK, light neurofilaments, creatinine and eGFR, urea, sodium, potassium, iron, ferritin, blood count 5. Ultrasound of cervical muscles assessed using the Hakkmatt scale 6. Neurophysiological study: 6.1. F wave 6.2. M wave 6.3. Cut. Silent Period 6.4. Symp. Skin. Response	—

Measure

Time frame

Measured before and after botulinum toxin administration: 1. Neuropsychological tests: 1.1. Cognitive function assessed using the Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), ACE-I EpiTrack 1.2. Anxiety disorders assessed using the Liebowitz Social Anxiety Scale 1.3. Depression assessed using the Beck Depression Scale 1.4. Pain assessed using the Numerical Rating Scale (NRS) 1.5. Sleep disorders assessed using the Epworth Sleep Scale 2. Functional assessment – mobility and posture examination: 2.1. Posturography: 2.1.1. Average displacement velocity (anteroposterior [AP] and mediolateral [ML]) 2.1.2. Path length 2.1.3. Romberg index 2.1.4. Root mean square (RMS) (AP and ML) 2.2. Up-And-Go Test 2.3. Tinetti test 3. Schellong test: 3.1. Systolic blood pressure (SBP) 3.2. Diastolic blood pressure (DBP) 3.3. Heart rate (HR) Measured during lying and standing position 4. Laboratory tests: S100 calcium-binding protein B (S100B molecule), neuron-specific enolase (NSE), occludin (OCLN), claudin-5 (CLN5), zonula occludens-1 (zo-1), sPECAM-1, sICAM-1, myoglobin, creatine kinase CK, light neurofilaments, creatinine and eGFR, urea, sodium, potassium, iron, ferritin, blood count 5. Ultrasound of cervical muscles assessed using the Hakkmatt scale 6. Neurophysiological study: 6.1. F wave 6.2. M wave 6.3. Cut. Silent Period 6.4. Symp. Skin. Response

—

Secondary

Measure	Time frame
1. Clinical severity of cervical dystonia assessed using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) before and after botulinum toxin administration 2. Patient-reported quality of life measured using Cervical Dystonia Questionnaire (CDQ-24) before and after botulinum toxin administration	—

Countries

Poland

Contacts

Public ContactMalgosia Dudzic

gosiadudzic@gmail.com+48609050376

Outcome results

None listed

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