Clinical trial NCT06881147: Physiotherapy and Botox for Cervical Dystonia: Impact of Sensory Tricks and Brain Imaging Insights
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Dystonia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Ospedale San Luca, Istituto Auxologico Italiano, Milano
First posted: 2025-03-18
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a comparative study: two parallel groups will undergo the same treatment. Patients will be included if they have a Cervical Dystonia both with and without and effective sensory trick. 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).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

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.


Eligibility criteria: Inclusion Criteria fo patients with Cervical Dystonia:

* 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

Exclusion Criteria for all participants

* presence of fixed postures because of skeletal neck deformity;
* history of (other) systemic, neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at an MRI scan;
* alcohol and/or psychotropic drugs abuse;
* 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).

Primary outcomes:
measure: Toronto Western Spasmodic Rating Scale (TWSTRS) score
timeFrame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Secondary outcomes:
measure: Cervical range of motion
timeFrame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
measure: Cervical Dystonia Impact Scale (CDIP-58) score
timeFrame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
measure: Beck Depression inventory (BDI) score
timeFrame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
measure: Hamilton Anxiety Rating Scale (HAM-A) score
timeFrame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
measure: Short-latency afferent inhibition (SAI) paradigm using transcranial magnetic stimulation (TMS)
timeFrame: Baseline, after training (week 6)
measure: Brain functional changes during functional magnetic resonance imaging (MRI) task
timeFrame: Baseline, after training (week 6)
measure: Brain functional changes during functional magnetic resonance imaging (MRI) "conventional" resting state
timeFrame: Baseline, after training (week 6)
measure: Brain functional changes during functional magnetic resonance imaging (MRI) "sensory trick" resting state
timeFrame: Baseline, after training (week 6)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Italia
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Massimo MF Filippi, MD
role: PRINCIPAL_INVESTIGATOR
References: