An interventional study of DystoniaNet-based diagnosis of isolated dystonia in Dystonia, Drug Induced Dystonia and Parkinson Disease, sponsored by Massachusetts Eye and Ear Infirmary. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Diagnostic
This research involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia.
Isolated dystonia is a movement disorder of unknown pathophysiology, which causes involuntary muscle contractions leading to abnormal, typically patterned, twisting movements and postures. A significant challenge in the clinical management of dystonia is due to the absence of a biomarker and associated 'gold' standard diagnostic test. Currently, the diagnosis of dystonia is guided by clinical evaluations of its symptoms, which lead to a low agreement between clinicians and a high rate of diagnostic inaccuracies. It is estimated that only 5% of patients receive an accurate diagnosis at symptom onset, and the average diagnostic delay extends up to 10.1 years. This study will conduct retrospective and prospective studies to clinically validate the performance of DystoniaNet, a biomarker-based deep learning platform for the diagnosis of isolated dystonia.
The retrospective studies will clinically validate the diagnostic performance of the DystoniaNet algorithm (1) in patients compared to healthy subjects (normative test), and (2) between patients with dystonia and other neurological and non-neurological conditions (differential test).
The prospective randomized study will validate the performance of DystoniaNet algorithm for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting.
This research is expected to advance the DystoniaNet algorithm for dystonia diagnosis into its clinical use for increased accuracy of dystonia diagnosis. Early detection and diagnosis of dystonia will enable its early therapy and improved prognosis, having an overall positive impact on healthcare and patients' quality of life.
121 studies on the registry are indexed under Torticollis; 18 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 50 across 76 interventional studies indexed under Torticollis.
Browse Torticollis studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Compared within Torticollis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dystonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Retrospective studies will (1) clinically validate the diagnostic performance of DystoniaNet compared to a normal neurological state (normative test), and (2) develop and test DystoniaNet extensions in comparison with other neurological and non-neurological conditions (differential test).
Prospective randomized studies will validate DystoniaNet performance for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting.
Diagnostic Test: DystoniaNet-based diagnosis of isolated dystonia
DystoniaNet will be used for the diagnosis of dystonia and its differential diagnosis from other neurological and non-neurological disorders mimicking symptoms of dystonia
Correctness of clinical diagnosis of dystonia using the DystoniaNet algorithm
Correctness of dystonia diagnosis (yes dystonia/no dystonia) will be established using the DystoniaNet machine-learning algorithm
Time frame: 4 years
Time of clinical diagnosis of dystonia using the DystoniaNet algorithm
The length of time (in months) from symptom onset to clinical diagnosis will be established using the DystoniaNet machine-learning algorithm
Time frame: 4 years
Started Jun 2022 (actual). Primary completion is estimated for Apr 2028, 70 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts Eye and Ear Infirmary →