UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]

NCT07233993 | Recruiting

• 1 other identifier: CUSTODY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain. The main questions it aims to answer are:

• Do ultrasound-guided BoNT injections improve quality of life more than injections without ultrasound?
• Are ultrasound-guided injections as safe as injections without ultrasound? Researchers will compare:
• BoNT injections with ultrasound guidance
• BoNT injections without ultrasound guidance (based only on body landmarks) Participants will:
• Receive both types of injections during the study (one first, then the other)
• Complete questionnaires about quality of life, movement, pain, and mood
• Attend follow-up visits over about 8 months About 37 adults with cervical dystonia will take part. The study will take place at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy.

Conditions

Idiopathic Cervical Dystonia

Keywords

Cervical dystonia; Idiopathic cervical dystonia; Botulinum toxin; BoNT injections; Ultrasound-guided injections; Anatomical landmark; Quality of life; Motor symptoms; Non-motor symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score

  Total score on the Cervical Dystonia Impact Profile (CDIP-58), a patient-reported outcome measure of quality of life in cervical dystonia. Score range: 0-100, with higher scores indicating greater impact on quality of life (worse outcome).

  6 weeks (±2 weeks) after each treatment, during both periods of the cross-over desig

Secondary Outcomes (7)

• Change in Toronto Western Spasmodic Torticollis Rating Scale - 2 (TWSTRS-2)

  6 weeks (±2 weeks) after each treatment, during both periods of the cross-over design.

• Change in Psychiatric Screening Tool (TWSTRS-PSYCH) score

  6 weeks (±2 weeks) after each treatment, during both periods of the cross-over design.

• Change in Hospital Anxiety and Depression Scale (HADS) score

  6 weeks (±2 weeks) after each treatment, during both periods of the cross-over design.

• Change in Pain Numerical Rating Scale (NRS) score

  6 weeks (±2 weeks) after each treatment, during both periods of the cross-over design.

• Change in Clinical Global Impression - Change (CGI-C) score

  6 weeks (±2 weeks) after each treatment, during both periods of the cross-over design.

Study Arms (2)

Ultrasound-Guided BoNT Injections

EXPERIMENTAL

Participants receive botulinum toxin type A injections into cervical muscles using real-time ultrasound guidance to visualise target muscles and surrounding structures

Procedure: Ultrasound-guided botulinum toxin injection; Procedure: Non-ultrasound-guided botulinum toxin injection

Non-Ultrasound-Guided BoNT Injections

SHAM COMPARATOR

Participants receive botulinum toxin type A injections into cervical muscles using anatomical landmarks, without ultrasound guidance. The ultrasound device is present but the screen is turned off to maintain blinding.

Procedure: Ultrasound-guided botulinum toxin injection; Procedure: Non-ultrasound-guided botulinum toxin injection

Interventions

Ultrasound-guided botulinum toxin injection PROCEDURE

Botulinum toxin type A is injected into dystonic cervical muscles under real-time ultrasound guidance, allowing visualisation of target muscles and adjacent structures. Injections are performed according to standard clinical practice with a stable dose and scheme

Non-Ultrasound-Guided BoNT Injections; Ultrasound-Guided BoNT Injections

Non-ultrasound-guided botulinum toxin injection PROCEDURE

Botulinum toxin type A is injected into dystonic cervical muscles using anatomical landmarks, without ultrasound guidance. To maintain blinding, the ultrasound device is present in all procedures, but the screen is turned off in this arm. Injections are performed according to standard clinical practice with a stable dose and scheme

Non-Ultrasound-Guided BoNT Injections; Ultrasound-Guided BoNT Injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age 18 years old
• Clinical diagnosis of Idiopathic Cervical Dystonia
• On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to screening and expected to be maintained throughout the study
• Treatment non-naïve to BoNT type A therapy for CD
• At least 4 months have passed between the last BoNT injection at screening
• Good clinical response to previous BoNT injections, on stable dosing and treatment scheme
• Informed Consent as documented by signature.
• Ability to perform study requirements (to attend assessment and treatments)

You may not qualify if:

• Diagnosis of other types of Cervical Dystonia (Inherited and Acquired)
• Concomitant diagnosis of diseases that contraindicate the use of botulinum toxin, such as myasthenia gravis
• Known hypersensitivity or allergy to Botulinum-A Toxin
• Women who are pregnant or breast feeding
• Intention to become pregnant during the study
• Lack of safe contraception
• Other clinically significant and unstable concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Previous enrolment into the current study

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

Related Publications (1)

• Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.

  PMID: 23649720 BACKGROUND

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roberto Eleopra, MD

CONTACT

+ 39 02.2394; roberto.eleopra@istituto-besta.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to the injection technique. Injectors cannot be blinded for practical reasons. To maintain blinding, the ultrasound device will be present in all procedures. For participants randomized to the non-ultrasound group, the ultrasound probe will be positioned but the device screen will be turned off, so that the procedure appears identical to an ultrasound-guided injection.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, prospective, randomized, double-blind, sham-controlled, cross-over clinical trial. Participants with idiopathic cervical dystonia will receive both ultrasound-guided and non-ultrasound-guided botulinum toxin injections in two treatment periods, serving as their own control.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)