Cervical DystoniaNCT06881147
Physiotherapy and Botox for Cervical Dystonia: Impact of Sensory Tricks and Brain Imaging Insights
A study testing Multimodal physiotherapy program in people with Cervical Dystonia, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Multimodal physiotherapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2019to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read more
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
- Being tested
- Multimodal physiotherapy program
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal physiotherapy programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Multimodal physiotherapy program |
| Healthy subjects | No intervention | Age- and sex-matched healthy subjects recruited to compare clinical and MRI characteristics at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Secondary outcomes (8)
Cervical range of motion
Measure cervical active ROM (flexion, extension and lateral flexion) using electromagnetic sensors and the Virtual Reality Rehabilitation System (VRRS)
Measured: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Cervical Dystonia Impact Scale (CDIP-58) score
Questionnaire assessing the impact of cervical dystonia on activities of daily living, mood and health (score 0-100, higher score = higher impact)
Measured: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Beck Depression inventory (BDI) score
Evaluates depression (score 0-63, higher score = worse depressive symptoms)
Measured: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Hamilton Anxiety Rating Scale (HAM-A) score
Evaluates anxiety (score 0-56, higher score = worse anxiety symptoms)
Measured: 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)
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
Measured: Baseline, after training (week 6)
Brain functional changes during functional magnetic resonance imaging (MRI) task
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.
Measured: Baseline, after training (week 6)
Brain functional changes during functional magnetic resonance imaging (MRI) "conventional" resting state
Subjects will be instructed to remain motionless and to keep their eyes closed
Measured: Baseline, after training (week 6)
Brain functional changes during functional magnetic resonance imaging (MRI) "sensory trick" resting state
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.
Measured: Baseline, after training (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start13 Apr 2019
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Luca, Istituto Auxologico Italiano, Milano
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
- Investigators
- Massimo MF Filippi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881147
- Sponsor's protocol ID
- DYT_sensory_trick
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06881147
- Acronym / sponsor ID
- DYT_sensory_trick
- Conditions
- Cervical Dystonia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Ospedale San Luca, Istituto Auxologico Italiano, Milano
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Patients with Cervical Dystonia and an effective sensory trick (DYT-trick) | Experimental | Behavioral: Multimodal physiotherapy programPatients with an effective sensory trick will undergo a multimodal physiotherapy program for 6 weeks |
| Patients with Cervical Dystonia and without an effective sensory trick (DYT-no-trick) | Experimental | Behavioral: Multimodal physiotherapy programPatients without an effective sensory trick will undergo a multimodal physiotherapy program for 6 weeks |
| Healthy subjects | No intervention | –Age- and sex-matched healthy subjects recruited to compare clinical and MRI characteristics at baseline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal physiotherapy programMultimodal 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. | Behavioural | Patients with Cervical Dystonia and an effective sensory trick (DYT-trick), Patients with Cervical Dystonia and without an effective sensory trick (DYT-no-trick) |
Primary outcome
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)
8 secondary outcomes
Cervical range of motion
Time frame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Cervical Dystonia Impact Scale (CDIP-58) score
Time frame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Beck Depression inventory (BDI) score
Time frame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)
Hamilton Anxiety Rating Scale (HAM-A) score
Time frame: 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)
Time frame: Baseline, after training (week 6)
Brain functional changes during functional magnetic resonance imaging (MRI) task
Time frame: Baseline, after training (week 6)
Brain functional changes during functional magnetic resonance imaging (MRI) "conventional" resting state
Time frame: Baseline, after training (week 6)
Brain functional changes during functional magnetic resonance imaging (MRI) "sensory trick" resting state
Time frame: Baseline, after training (week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo MF Filippi, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal physiotherapy program in people with Cervical Dystonia, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Western Spasmodic Rating Scale (TWSTRS) score (time frame: Baseline, after training (week 6) and 6 weeks after the end of training (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.