Physiotherapy and Botox for Cervical Dystonia: Impact of Sensory Tricks and Brain Imaging Insights

NCT06881147 | Enrolling By Invitation DMC

• 1 other identifier: DYT_sensory_trick
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Toronto Western Spasmodic Rating Scale (TWSTRS) score

  Rating scale measuring severity, disability and pain associated with cervical dystonia (score 0-85, higher score = worse condition)

  Baseline, after training (week 6) and 6 weeks after the end of training (week 12)

Secondary Outcomes (8)

• Cervical range of motion

  Baseline, after training (week 6) and 6 weeks after the end of training (week 12)

• Cervical Dystonia Impact Scale (CDIP-58) score

  Baseline, after training (week 6) and 6 weeks after the end of training (week 12)

• Beck Depression inventory (BDI) score

  Baseline, after training (week 6) and 6 weeks after the end of training (week 12)

• Hamilton Anxiety Rating Scale (HAM-A) score

  Baseline, after training (week 6) and 6 weeks after the end of training (week 12)

• Short-latency afferent inhibition (SAI) paradigm using transcranial magnetic stimulation (TMS)

  Baseline, after training (week 6)

Study Arms (3)

Patients with Cervical Dystonia and an effective sensory trick (DYT-trick)

EXPERIMENTAL

Patients with an effective sensory trick will undergo a multimodal physiotherapy program for 6 weeks

Behavioral: Multimodal physiotherapy program

Patients with Cervical Dystonia and without an effective sensory trick (DYT-no-trick)

EXPERIMENTAL

Patients without an effective sensory trick will undergo a multimodal physiotherapy program for 6 weeks

Behavioral: Multimodal physiotherapy program

Healthy subjects

NO INTERVENTION

Age- and sex-matched healthy subjects recruited to compare clinical and MRI characteristics at baseline.

Interventions

Multimodal physiotherapy program BEHAVIORAL

Multimodal physiotherapy program of 6 weeks (3 times a week for 45 minutes), each session will include: * Soft tissue mobilization of inoculated muscles; * Stretching exercises of the inoculated muscles; * Strengthening of antagonist muscles; * Motor learning exercises (attentive strategies, feedback-based cervical active exercises). Exercises will be progressively difficult (increase of active ROM) according to clinical improvements.

Patients with Cervical Dystonia and an effective sensory trick (DYT-trick); Patients with Cervical Dystonia and without an effective sensory trick (DYT-no-trick)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Ospedale San Luca, Istituto Auxologico Italiano, Milano: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italia, 20132, Italy

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

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

Study Officials

• Massimo MF Filippi, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blind about the characteristics of the two groups. Considering the different clinical phenotypes of patients (DYT-trick and DYT-no-trick) clinical evaluators and physiotherapists cannot be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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).

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 18, 2025
• Study Start: April 13, 2019
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

IT (1)