ClinicalTrials.gg
CompletedNCT07923799MISAUpdated Nov 6, 2026

Protocol in Musician's Focal Dystonia (MISA)

An observational study in Focal Dystonia, Rehabilitation Exercise and Sensorimotor, sponsored by Fondazione Don Carlo Gnocchi ETS. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Fondazione Don Carlo Gnocchi ETS · Observational

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • 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
  • Motor Learning
  • Neurorehabilitation
  • Music Performance
  • Hand Dystonia
  • Graded Motor Training
  • Motor Control
  • Technical Ability and Performing Scale
  • TAPS
  • Modified Integrated Sensorimotor Approach
  • MISA
03

In context

Dystonic Disorders

95 studies on the registry are indexed under Dystonic Disorders; 19 are open to participants now.

This study's enrollment of 70 is above the median of 56 across 50 observational studies indexed under Dystonic Disorders.

Browse Dystonic Disorders studies →

Lead sponsor

Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 43 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 or absence of documented opposition to the processing of personal data for research purposes.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

    Behavioral: Modified Integrated Sensorimotor Approach (MISA)

Interventions

  • BehavioralModified 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.

Secondary outcomes

  1. 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.

    Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.

  2. 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.

    Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.

  3. 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.

    Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.

  4. 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.

    Time frame: From baseline (T0) through end of treatment (T1), up to 24 weeks.

07

Study locations

2 sites
  • IRCCS Fondazione Don Carlo Gnocchi - Santa Maria Nascente
    Milan, Italy 20148, Italy
  • IRCCS Fondazione Don Carlo Gnocchi - Centro IRCCS Don Carlo Gnocchi Firenze
    Florence, Italy
08

References and documents

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 30009212 ↗
  • Ramella 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 35623227 ↗
  • Ramella 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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in May 2026, 106 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Nov 6, 2026
StartActual
Jul 1, 2017
Primary completionActual
May 1, 2026
CompletionActual
May 1, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923799
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Collaborators
Ministry of Health, Italy
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Jul 1, 2017
Primary completion
May 1, 2026
Completion
May 1, 2026
Last update
Nov 6, 2026

Study contacts

Marina Ramella, MD
principal investigator · IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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