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Enrolling by Invitation

NCT Number: NCT06881147

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

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.

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ospedale San Raffaele

Milan, Italia, 20132, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Toronto Western Spasmodic Rating Scale (TWSTRS) score

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

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

Secondary outcomes

  1. Cervical range of motion

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

    Measure cervical active ROM (flexion, extension and lateral flexion) using electromagnetic sensors and the Virtual Reality Rehabilitation System (VRRS)

  2. Cervical Dystonia Impact Scale (CDIP-58) score

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

    Questionnaire assessing the impact of cervical dystonia on activities of daily living, mood and health (score 0-100, higher score = higher impact)

  3. Beck Depression inventory (BDI) score

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

    Evaluates depression (score 0-63, higher score = worse depressive symptoms)

  4. Hamilton Anxiety Rating Scale (HAM-A) score

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

    Evaluates anxiety (score 0-56, higher score = worse anxiety symptoms)

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

    Time frame: Baseline, after training (week 6)

    TMS will be performed with a high power Magstim 200. A figure-of-eight Coil (70 mm external diameter) will be positioned over the hand area of the motor cortex. Motor evoked potentials (MEPs) will be recorded from first dorsal interosseous muscle (FDI) of the hand not performing the sensory trick. Resting motor threshold (RMT) will be determined starting below the expected threshold, with 5% stimulator output increments. RMT will be reported as percentage of maximum stimulator output (% MSO). To assess the SAI a conditioning electrical pulses will be applied through a bipolar electrode to the median nerve (not involved in sensory trick) at the wrist (cathode proximal). SAI will be randomly applied in two conditions: (A) at rest, with the patient's head positioned according to its dystonic pattern and (B) while patients will be performing the sensory trick

  6. Brain functional changes during functional magnetic resonance imaging (MRI) task

    Time frame: Baseline, after training (week 6)

    A block design (ABAB) will be used, in which activation periods (A) alternated with resting-state periods (B). During activation periods (at the acoustic signal "go") DYT-trick patients will be asked to imagine their own effective sensory trick while DYT no-trick will imagine a simulation of sensory trick. Before scanning, participants will familiarize with the experimental condition.

  7. Brain functional changes during functional magnetic resonance imaging (MRI) "conventional" resting state

    Time frame: Baseline, after training (week 6)

    Subjects will be instructed to remain motionless and to keep their eyes closed

  8. Brain functional changes during functional magnetic resonance imaging (MRI) "sensory trick" resting state

    Time frame: Baseline, after training (week 6)

    Before scanning DYT subjects will be asked to execute (DYT-trick) or to simulate (DYT-no-trick) the sensory trick (i.e. slight touch on the cheek/chin) and to maintain it for the entire scanning. During scanning, DYT subjects will be instructed to remain motionless and to keep their eyes closed.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Ospedale San Luca, Istituto Auxologico Italiano, Milano

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Mar 18, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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