How botulinum toxin treatment affects people with involuntary neck movements (cervical dystonia)
| ISRCTN | ISRCTN11389213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11389213 |
- Submission date
- 18/10/2025
- Registration date
- 22/10/2025
- Last edited
- 22/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Some people develop a condition called cervical dystonia, which causes involuntary muscle contractions in the neck. This can lead to abnormal head posture and neck pain. The most effective treatment is injecting botulinum toxin type A into specific neck muscles to help them relax.
This study aims to understand how this treatment affects not just movement and muscle control, but also psychological wellbeing, nervous system function, and certain blood markers. Researchers hope this will improve understanding of how the treatment works and help identify signs that show whether it’s working well.
Who can participate?
Adults aged 18–75 years diagnosed with idiopathic cervical dystonia (meaning the cause is unknown) may be eligible to take part.
What does the study involve?
Participants are assessed before and after receiving their usual botulinum toxin treatment. This includes a neurological examination, psychological and nervous system testing, and blood tests to look at biochemical markers.
What are the possible benefits and risks of participating?
There may be no direct benefit to participants, but the results could help improve future treatment and understanding of cervical dystonia. Risks are minimal and mainly related to standard medical procedures like blood tests.
Where is the study run from?
The study is being carried out at the Department of Neurology and Occupational Therapy at the Karol Marcinkowski Medical University in Poznań, Poland.
When is the study starting and how long is it expected to run for?
June 2023 to May 2027
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr A. Drużdż, adruzdz@op.pl
2. Dr M. Dudzic, gosiadudzic@gmail.com
Contact information
Scientific
Szwajcarska 3
Poznań
61285
Poland
 ORCID ID |
0000-0002-4479-4135 |
|---|---|
| Phone | +48 (0)502121222 |
| adruzdz@szpital-strusia.xn--pozna-07a.pl |
Public
Szwajcarska 3
Poznań
62020
Poland
| Phone | +48609050376 |
|---|---|
| gosiadudzic@gmail.com |
Principal Investigator
Święcickiego 6
Poznań
60781
Poland
| Phone | +48 (0)601509967 |
|---|---|
| Khojan@ump.edu.pl |
Study information
| Study design | Observational prospective pre–post comparison study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Laboratory, University/medical school/dental school |
| Study type | Diagnostic, Quality of life, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | 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 |
| Study objectives | The project aimed to comprehensively evaluate patients with dystonia treated with botulinum toxin in the NHF therapeutic program. Most of the examinations were conducted twice – before and after botulinum toxin administration. The evaluation included: 1. Neurological examination 2. Functional examination 3. Neurophysiological examination 4. Radiological examination 5. Serum biochemical concentrations 6. Neuropsychological examination |
| Ethics approval(s) |
Approved 29/06/2023, Bioethics Committee of the Karol Marcinkowski Medical University in Poznań (Bukowska 70, Poznań, 60-820, Poland; +48 (0)618547336; bioetyka.ump@ump.edu.pl), ref: No. 523/2023 |
| Health condition(s) or problem(s) studied | Idiopathic cervical dystonia |
| Intervention | 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 accordance with the NHF's needs, a selected group of patients meeting the inclusion criteria will be asked about participation in the study following their previous injection. After obtaining initial consent, they will be informed about the study according to the study protocol and will have time to review it. After providing initial consent, upon arrival for their scheduled treatment, they will be re-reviewed, allowed to ask questions, and required to sign a consent form. The study will be conducted twice – before the scheduled botulinum toxin administration – in accordance with the NHF program (the toxin doesn't work) and after 4-6 weeks (the toxin works best). The order may be reversed. Patients will only be observed twice during visits when the toxin has finished its action and when it has its best effect. The following data and results will be collected: 1. A questionnaire survey to determine age, gender, education, type of work, time of onset of the first symptoms of dystonia, date of diagnosis, comorbidities, and medications used for chronic and acute treatment. Typical scales of CD – classification of Col-Cap and Toronto. 2. Neuropsychological tests to assess cognitive function and assessment of the severity of anxiety disorders, depression, pain, sleep disorders. 3. Functional assessment – mobility and posture examination. 4. Assessment of autonomic nervous system. 5. Blood tests 6. Analysis of radiological examinations routinely performed as part of the mandatory qualification for treatment (MR or CT of the head or neck). 7. Muscle examination using ultrasound. 8. Neurophysiological examination: assessment of muscles in EMG (F and M waves, SSR), CSP (Cutaneous Silence Period). The collected data will be statistically analyzed and correlated with each other. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Botulinum toxin |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2023 |
| Completion date | 31/05/2027 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 72 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/07/2023 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Poland
Study participating centres
6 Święcicki Street
Poznań
60-781
Poland
Szwajcarska 3
Poznań
61-285
Poland
Sponsor information
Hospital/treatment centre
Department of Neurology
Szwajcarska 3
Poznań
61285
Poland
| Phone | +48 (0)618739420 |
|---|---|
| adruzdz@szpital-strusia.xn--pozna-07a.pl |
Hospital/treatment centre
Department of Occupational Therapy
Swięcickiego 6
Poznan
60781
Poland
| Phone | +48 (0)61 854 65 73 |
|---|---|
| ztz@ump.edu.pl | |
| Website | https://terapiazajeciowa.ump.edu.pl |
"ROR" |
https://ror.org/02zbb2597 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 06/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Individual participant data will not be publicly available due to privacy and ethical restrictions. However, anonymised datasets may be shared upon reasonable request to the corresponding author for research purposes consistent with ethical approval. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/08/2025 | 20/10/2025 | Yes | No | |
| Protocol file | 22/10/2025 | No | No | ||
| Protocol file | 22/10/2025 | No | No |
