Focal DystoniaMISANCT07923799
Protocol in Musician's Focal Dystonia (MISA)
An observational study of Focal Dystonia and Rehabilitation Exercise, run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
Trial summary
Musician's Focal Dystonia (MFD) is a task-specific movement disorder that impairs fine motor control during musical performance and may severely affect professional and amateur musicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Dystonia, Rehabilitation Exercise, Sensorimotor
- What is being tested?
- Modified Integrated Sensorimotor Approach (MISA)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2017to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult professional and amateur musicians with instrument-specific focal hand dystonia who initiated the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program at the Sol Diesis Outpatient Clinic, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. Participants were identified through retrospective review of medical records collected between July 2017 and May 2026. Both program completers and participants who discontinued treatment were included in the study.
Who may be able to join
- Age ≥18 years.
- Professional or amateur musician.
- Clinical diagnosis of instrument-specific focal dystonia.
- Participation in the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program.
- Availability of baseline Technical Ability and Performing Scale (TAPS) assessment.
- Availability of post-treatment TAPS assessment, when available.
- Availability of informed consent or absence of documented opposition to the processing of personal data for research purposes.
Who cannot join
- Neurological disorders or clinical conditions potentially mimicking or confounding the diagnosis of focal dystonia.
- Forms of dystonia other than instrument-specific focal dystonia.
- Insufficient baseline clinical documentation.
- Botulinum toxin treatment within 3 months prior to initiation of the MISA program.
- Botulinum toxin treatment administered during the MISA rehabilitation program.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Fondazione Don Carlo Gnocchi - Centro IRCCS Don Carlo Gnocchi Firenze
Florence
IRCCS Fondazione Don Carlo Gnocchi - Santa Maria Nascente
Milan, Italy, 20148
About this study
Official title: Effectiveness of the MISA (Mirror Integrated Sensorimotor Approach) Rehabilitation Protocol for Musicians With Focal Dystonia: A Retrospective Observational Study
Musician's Focal Dystonia (MFD) is a task-specific movement disorder that impairs fine motor control during musical performance and may severely affect professional and amateur musicians. The Modified Integrated Sensorimotor Approach (MISA) is a standardized home-based rehabilitation program that combines mirror therapy, sensory reorganization exercises, graded motor training, and motor awareness strategies to promote sensorimotor retraining.
This retrospective observational study aims to evaluate the association between participation in the MISA rehabilitation program and changes in musical performance among musicians with focal hand dystonia. Musical performance is assessed using the Technical Ability and Performing Scale (TAPS), a patient-reported outcome measure specifically developed for musicians with focal dystonia. Secondary objectives include the investigation of clinical and individual factors potentially associated with treatment response.
The study consists of a review of clinical records of patients who completed the MISA program as part of routine clinical care at the Sol Diesis Outpatient Clinic, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Read the detailed description
Musician's Focal Dystonia (MFD) is a task-specific movement disorder characterized by loss of fine motor control, involuntary muscle contractions, and abnormal movement patterns that emerge during musical performance. The condition is thought to result from maladaptive neuroplasticity, impaired sensorimotor integration, and abnormalities in cortical inhibitory mechanisms. These alterations interfere with highly trained motor skills and may profoundly affect professional and amateur musicians.
Although pharmacological treatments, including botulinum toxin injections and oral medications, may provide symptomatic benefit, rehabilitation interventions have become an increasingly important component of MFD management. Previous studies have suggested that sensorimotor retraining approaches, including mirror therapy, sensory reorganization, graded motor training, and motor control exercises, may improve musical performance and reduce dystonic symptoms.
The Modified Integrated Sensorimotor Approach (MISA) is a structured home-based rehabilitation protocol developed at the Sol Diesis Outpatient Clinic of IRCCS Fondazione Don Carlo Gnocchi. The protocol integrates mirror therapy, sensory reorganization exercises, graded motor training, and motor awareness strategies within a progressive framework of increasing task complexity. The intervention aims to promote adaptive sensorimotor reorganization, improve movement selectivity, reduce maladaptive co-contraction patterns, and facilitate transfer of acquired motor skills to musical performance.
This retrospective observational study involves the review of medical records of adult musicians with instrument-specific focal dystonia who underwent the MISA rehabilitation program as part of routine clinical care between July 2017 and May 2026. Data collected include demographic and professional characteristics, clinical features of dystonia, treatment characteristics, and musical performance outcomes.
Musical performance was assessed using the Technical Ability and Performing Scale (TAPS), a patient-reported outcome measure specifically developed for musicians with focal dystonia. Assessments performed before treatment initiation (T0) and at completion of the rehabilitation program (T1) were used to evaluate treatment-related changes.
The primary objective of the study is to explore the association between participation in the MISA rehabilitation program and changes in musical performance measured by TAPS scores. Secondary objectives include the investigation of associations between treatment-related changes and individual or clinical characteristics of participants, including age, sex, instrument played, disease duration, dystonia pattern, and affected body segments.
The study is conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee CET Lombardia 4 (Approval No. CET 90-26).
- Conditions
- Focal Dystonia, Rehabilitation Exercise, Sensorimotor
- Being tested
- Modified Integrated Sensorimotor Approach (MISA)
- Keywords
- Musician's Focal Dystonia, Focal Hand Dystonia, Task-Specific Dystonia, Sensorimotor Retraining, Mirror Therapy, Motor Rehabilitation, Sensorimotor Integration, Musicians, Motor Learning, Neurorehabilitation, Music Performance, Hand Dystonia, Graded Motor Training, Motor Control, Technical Ability and Performing Scale, TAPS, Modified Integrated Sensorimotor Approach, MISA
- Medical subject headings
- Dystonic Disorders, Dystonia, Focal, Task-Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Integrated Sensorimotor Approach (MISA)Behavioural
The Modified Integrated Sensorimotor Approach (MISA) is a standardized home-based rehabilitation program for musicians with focal hand dystonia. The intervention combines mirror therapy, sensory reorganization exercises, graded motor training, motor awareness strategies, and progressive task-oriented practice. The program consists of six modules delivered across approximately 12 weeks, with individualized instruction provided by a physiotherapist and independent home exercises performed four days per week.
| Study group | Role | What they receive |
|---|---|---|
| Musicians With Focal Hand Dystonia Treated With MISA | Adult professional and amateur musicians with instrument-specific focal hand dystonia who completed the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program as part of routine clinical care. Participants were evaluated at baseline and after completion of the rehabilitation program using the Technical Ability and Performing Scale (TAPS). Receives: Behavioral: Modified Integrated Sensorimotor Approach (MISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS)
Change from baseline (T0) to post-treatment assessment (T1) in musical performance measured using the Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS). The TA score ranges from 0 to 10 points, with 0 indicating the poorest technical performance and 10 indicating the best technical performance. Higher scores indicate better technical performance.
Measured: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Secondary outcomes (4)
Change in Performimg Scale (PS) score of the Technical Ability and Performing Scale (TAPS)
Change from baseline (T0) to post-treatment assessment (T1) in musical performance measured using the Performance Scale (PS) score of the Technical Ability and Performing Scale (TAPS). The PS score ranges from 0 to 10 points, with 0 indicating the poorest musical performance and 10 indicating the best musical performance. Higher scores indicate better musical performance.
Measured: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Predictors of change in Technical Ability (TA) score
Exploratory analyses will assess the association between change in TA score (points) and participant characteristics, including age (years), sex, musical instrument, professional status, age at dystonia onset (years), disease duration (years), affected body side, affected body segments, number of affected segments, and dystonia pattern.
Measured: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Predictors of change in Performing Scale (PS) score
Exploratory analyses will assess the association between change in PS score (points) and participant characteristics, including age (years), sex, musical instrument, professional status, age at dystonia onset (years), disease duration (years), affected body side, affected body segments, number of affected segments, and dystonia pattern.
Measured: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Predictors of treatment dropout
Exploratory analysis of baseline predictors of treatment dropout. The outcome will be dropout status (dropout vs. treatment completion). Potential predictors assessed at baseline (T0) will include Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS) (points), Performance Scale (PS) score of the Technical Ability and Performing Scale (TAPS) (points), age (years), sex, musical instrument, professional status, age at dystonia onset (years), disease duration (years), affected body side, affected body segments, number of affected segments, and dystonia pattern.
Measured: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jul 2017
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focal DystoniaStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Marina Ramella, MD, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923799
- Sponsor's protocol ID
- MISA
- Acronym
- MISA
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to the retrospective nature of the study and the need to protect participant confidentiality and privacy.
Publications
Prudente CN, Zetterberg L, Bring A, Bradnam L, Kimberley TJ. Systematic Review of Rehabilitation in Focal Dystonias: Classification and Recommendations. Mov Disord Clin Pract. 2018 Mar 13;5(3):237-245. doi: 10.1002/mdc3.12574. eCollection 2018 May-Jun.
PubMed 30009212Ramella M, Converti RM, Giacobbi G, Castagna A, Saibene E, Borgnis F, Baglio F. The Technical Ability and Performing Scale (TAPS): A newly developed patient-reported functional rating scale for Musician's focal dystonia. Parkinsonism Relat Disord. 2022 Jun;99:79-83. doi: 10.1016/j.parkreldis.2022.05.015. Epub 2022 May 20.
PubMed 35623227Ramella M, Borgnis F, Giacobbi G, Castagna A, Baglio F, Cortesi M, Converti RM. Modified Graded Motor Imagery for Musicians' Focal Dystonia: A Case Series. Med Probl Perform Art. 2021 Mar;36(1):10-17. doi: 10.21091/mppa.2021.1002.
PubMed 33647092
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the MISA (Mirror Integrated Sensorimotor Approach) Rehabilitation Protocol for Musicians With Focal Dystonia: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07923799
- Acronym / sponsor ID
- MISA / MISA
- Conditions
- Focal Dystonia, Rehabilitation Exercise, Sensorimotor
- Keywords
- Musician's Focal Dystonia, Focal Hand Dystonia, Task-Specific Dystonia, Sensorimotor Retraining, Mirror Therapy, Motor Rehabilitation, Sensorimotor Integration, Musicians
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 6 Nov 2026 (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.
Musician's Focal Dystonia (MFD) is a task-specific movement disorder that impairs fine motor control during musical performance and may severely affect professional and amateur musicians. The Modified Integrated Sensorimotor Approach (MISA) is a standardized home-based rehabilitation program that combines mirror therapy, sensory reorganization exercises, graded motor training, and motor awareness strategies to promote sensorimotor retraining.
This retrospective observational study aims to evaluate the association between participation in the MISA rehabilitation program and changes in musical performance among musicians with focal hand dystonia. Musical performance is assessed using the Technical Ability and Performing Scale (TAPS), a patient-reported outcome measure specifically developed for musicians with focal dystonia. Secondary objectives include the investigation of clinical and individual factors potentially associated with treatment response.
The study consists of a review of clinical records of patients who completed the MISA program as part of routine clinical care at the Sol Diesis Outpatient Clinic, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Detailed description
Musician's Focal Dystonia (MFD) is a task-specific movement disorder characterized by loss of fine motor control, involuntary muscle contractions, and abnormal movement patterns that emerge during musical performance. The condition is thought to result from maladaptive neuroplasticity, impaired sensorimotor integration, and abnormalities in cortical inhibitory mechanisms. These alterations interfere with highly trained motor skills and may profoundly affect professional and amateur musicians.
Although pharmacological treatments, including botulinum toxin injections and oral medications, may provide symptomatic benefit, rehabilitation interventions have become an increasingly important component of MFD management. Previous studies have suggested that sensorimotor retraining approaches, including mirror therapy, sensory reorganization, graded motor training, and motor control exercises, may improve musical performance and reduce dystonic symptoms.
The Modified Integrated Sensorimotor Approach (MISA) is a structured home-based rehabilitation protocol developed at the Sol Diesis Outpatient Clinic of IRCCS Fondazione Don Carlo Gnocchi. The protocol integrates mirror therapy, sensory reorganization exercises, graded motor training, and motor awareness strategies within a progressive framework of increasing task complexity. The intervention aims to promote adaptive sensorimotor reorganization, improve movement selectivity, reduce maladaptive co-contraction patterns, and facilitate transfer of acquired motor skills to musical performance.
This retrospective observational study involves the review of medical records of adult musicians with instrument-specific focal dystonia who underwent the MISA rehabilitation program as part of routine clinical care between July 2017 and May 2026. Data collected include demographic and professional characteristics, clinical features of dystonia, treatment characteristics, and musical performance outcomes.
Musical performance was assessed using the Technical Ability and Performing Scale (TAPS), a patient-reported outcome measure specifically developed for musicians with focal dystonia. Assessments performed before treatment initiation (T0) and at completion of the rehabilitation program (T1) were used to evaluate treatment-related changes.
The primary objective of the study is to explore the association between participation in the MISA rehabilitation program and changes in musical performance measured by TAPS scores. Secondary objectives include the investigation of associations between treatment-related changes and individual or clinical characteristics of participants, including age, sex, instrument played, disease duration, dystonia pattern, and affected body segments.
The study is conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee CET Lombardia 4 (Approval No. CET 90-26).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musicians With Focal Hand Dystonia Treated With MISA | – | Behavioral: Modified Integrated Sensorimotor Approach (MISA)Adult professional and amateur musicians with instrument-specific focal hand dystonia who completed the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program as part of routine clinical care. Participants were evaluated at baseline and after completion of the rehabilitation program using the Technical Ability and Performing Scale (TAPS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult professional and amateur musicians with instrument-specific focal hand dystonia who initiated the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program at the Sol Diesis Outpatient Clinic, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. Participants were identified through retrospective review of medical records collected between July 2017 and May 2026. Both program completers and participants who discontinued treatment were included in the study.
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Professional or amateur musician.
- Clinical diagnosis of instrument-specific focal dystonia.
- Participation in the Modified Integrated Sensorimotor Approach (MISA) rehabilitation program.
- Availability of baseline Technical Ability and Performing Scale (TAPS) assessment.
Key exclusion criteria (5 listed)
- Neurological disorders or clinical conditions potentially mimicking or confounding the diagnosis of focal dystonia.
- Forms of dystonia other than instrument-specific focal dystonia.
- Insufficient baseline clinical documentation.
- Botulinum toxin treatment within 3 months prior to initiation of the MISA program.
- Botulinum toxin treatment administered during the MISA rehabilitation program.
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 |
|---|---|---|
| Modified Integrated Sensorimotor Approach (MISA)The Modified Integrated Sensorimotor Approach (MISA) is a standardized home-based rehabilitation program for musicians with focal hand dystonia. The intervention combines mirror therapy, sensory reorganization exercises, graded motor training, motor awareness strategies, and progressive task-oriented practice. The program consists of six modules delivered across approximately 12 weeks, with individualized instruction provided by a physiotherapist and independent home exercises performed four days per week. | Behavioural | Musicians With Focal Hand Dystonia Treated With MISA |
Primary outcome
Change in Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS)
Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Change from baseline (T0) to post-treatment assessment (T1) in musical performance measured using the Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS). The TA score ranges from 0 to 10 points, with 0 indicating the poorest technical performance and 10 indicating the best technical performance. Higher scores indicate better technical performance.
4 secondary outcomes
Change in Performimg Scale (PS) score of the Technical Ability and Performing Scale (TAPS)
Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Predictors of change in Technical Ability (TA) score
Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Predictors of change in Performing Scale (PS) score
Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Predictors of treatment dropout
Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 30009212Prudente CN, Zetterberg L, Bring A, Bradnam L, Kimberley TJ. Systematic Review of Rehabilitation in Focal Dystonias: Classification and Recommendations. Mov Disord Clin Pract. 2018 Mar 13;5(3):237-245. doi: 10.1002/mdc3.12574. eCollection 2018 May-Jun.
- Background: PubMed 35623227Ramella M, Converti RM, Giacobbi G, Castagna A, Saibene E, Borgnis F, Baglio F. The Technical Ability and Performing Scale (TAPS): A newly developed patient-reported functional rating scale for Musician's focal dystonia. Parkinsonism Relat Disord. 2022 Jun;99:79-83. doi: 10.1016/j.parkreldis.2022.05.015. Epub 2022 May 20.
- Background: PubMed 33647092Ramella M, Borgnis F, Giacobbi G, Castagna A, Baglio F, Cortesi M, Converti RM. Modified Graded Motor Imagery for Musicians' Focal Dystonia: A Case Series. Med Probl Perform Art. 2021 Mar;36(1):10-17. doi: 10.21091/mppa.2021.1002.
- The Sol Diesis Outpatient Clinic is a specialized multidisciplinary service dedicated to the prevention, assessment, and rehabilitation of performing artists, with particular expertise in musicians affected by task-specific movement disorders.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to the retrospective nature of the study and the need to protect participant confidentiality and privacy.
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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. This study is not recruiting at the moment.
Marina Ramella, MD principal investigator
IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Dystonia and Rehabilitation Exercise, run by Fondazione Don Carlo Gnocchi ETS at 2 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Technical Ability (TA) score of the Technical Ability and Performing Scale (TAPS) (time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07923799, which also lists 3 linked publications.
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 6 Nov 2026.