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

NCT ID: NCT06881147

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-13
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Multimodal physiotherapy program

Intervention Type: 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 without an effective sensory trick (DYT-no-trick)

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

Group Type: EXPERIMENTAL

Multimodal physiotherapy program

Intervention Type: 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.

Healthy subjects

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multimodal physiotherapy program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ospedale San Luca, Istituto Auxologico Italiano, Milano

UNKNOWN

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Prof. Massimo Filippi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo MF Filippi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

IRCCS Ospedale San Raffaele

Milan, Italia, Italy

Countries

Italy

Other Identifiers

DYT_sensory_trick

Identifier Type: -

Identifier Source: org_study_id