Physiotherapy and Botox for Cervical Dystonia: Impact of Sensory Tricks and Brain Imaging Insights
Key facts
- Who runs it
- IRCCS San Raffaele
- Where
- Milan, ItalySee the site
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 49 people, planned
- Started
- 13 Apr 2019
- Expected to end
- 1 Jan 2027
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Multimodal physiotherapy program
- Record updated
- 1 May 2025
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Adult onset idiopathic CD according to established diagnostic criteria (Albanese et al., Eur J Neur, 2011) with and without an effective sensory trick will be eligible for the study
Who cannot take part
- alcohol and/or psychotropic drugs abuse
- history of (other) systemic, neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at an MRI scan
- contraindication to perform MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with magnetic field generated by MRI, claustrophobia)
- presence of fixed postures because of skeletal neck deformity
Where in Italy
- IRCCS Ospedale San RaffaeleMilan, ItalyNo longer taking part
About the trial
What the trial wants to find out
The primary aim of this study is to investigate improvements of dystonia severity in patients with cervical dystonia (CD) with (DYT-trick) and without sensory trick (DYT-no-trick) following 6 weeks of physiotherapy combined with botulinum toxin injection (BoNT).
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The recruited patients will be divided into two groups according to the presence of an effective sensory trick (DYT trick and DYT no-trick groups).
The researchers analyzing clinical, neurophysiological and MRI data as well as the statistician will be blind about the allocation of subjects to the two groups. Considering the different clinical phenotypes of patients (DYT-trick and DYT-no-trick) clinical evaluators and physiotherapists cannot be blind.
All patients will perform the routinely BoNT injection and after 1 week they will start a multimodal physiotherapy program lasting 6 weeks, 3 times a week for 45 minutes each session. The physiotherapy treatment will include soft tissue mobilization of inoculated muscles, stretching exercises of the inoculated muscles, strengthening of antagonist muscles, and motor learning exercises (attentive strategies, feedback-based cervical active exercises). Exercises will be progressively difficult (increase of active range of motion -ROM) according to clinical improvements during the 6 weeks of treatment.
Clinical assessments will be performed at baseline (T0), after 6 weeks of treatment (W6) and before the next BoNT injection (about 12 weeks of follow-up, W12) to evaluate disease severity (TWSTRS), pain, active cervical range of motion, disability, quality of life and mood. Cervical movements during TWSTRS will be monitored using the Virtual Reality Rehabilitation System (VRRS), which includes the usage of magneto-inertial sensors to objectively assess joint positions and quality of movement. MRI evaluations will be performed at T0 and at W6 to investigate resting state functional Magnetic Resonance Imaging (fMRI) changes and fMRI changes of brain activation during the simulation and imagination of sensory trick.
SAI paradigm is obtained combing transcranial magnetic stimulation (TMS) with peripheral electrical stimulation techniques. It will be performed at baseline (before BoNT injection and physiotherapist training) and after week 6 of physiotherapist training.
A group of healthy subjects similar for age and sex to patients will be recruited to perform cognitive assessment and MRI at baseline.
The 3 groups in the trial
- Patients with Cervical Dystonia and an effective sensory trick (DYT-trick)Treatment being tested
Patients with an effective sensory trick will undergo a multimodal physiotherapy program for 6 weeks
Treatment: Multimodal physiotherapy program
- Patients with Cervical Dystonia and without an effective sensory trick (DYT-no-trick)Treatment being tested
Patients without an effective sensory trick will undergo a multimodal physiotherapy program for 6 weeks
Treatment: Multimodal physiotherapy program
- Healthy subjectsNo study treatment, for comparison
Age- and sex-matched healthy subjects recruited to compare clinical and MRI characteristics at baseline.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Physiotherapy Combined With Botulinum Neurotoxin in Patients With Cervical Dystonia With and Without an Effective Sensory Trick: Clinical and Functional MRI Findings
- Record updated
- 1 May 2025