Validation of a deep learning platform for diagnosing isolated dystonia
Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia
This study is testing a new deep learning tool to see if it can help doctors diagnose isolated dystonia more accurately and quickly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05317390 on ClinicalTrials.gov |
What this trial studies
This research focuses on validating the DystoniaNet deep learning platform for diagnosing isolated dystonia through both retrospective and prospective studies. Isolated dystonia is a movement disorder characterized by involuntary muscle contractions, and current diagnostic methods often lead to inaccuracies and delays. The study aims to compare the DystoniaNet algorithm's performance against healthy subjects and other conditions to establish its effectiveness. Ultimately, the goal is to enhance the accuracy and speed of dystonia diagnosis in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include individuals with various forms of dystonia or other movement disorders that may mimic dystonic symptoms.
Not a fit: Patients who cannot provide informed consent or have contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the accuracy and timeliness of dystonia diagnoses for patients.
How similar studies have performed: Other studies have shown promise in using deep learning for diagnostic purposes, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Males and females of diverse racial and ethnic backgrounds, with age across the lifespan; 2. Patients will have at least one of the forms of dystonia, including focal dystonia (e.g., laryngeal, cervical, oromandibular, blepharospasm, focal hand, musicians), segmental dystonia, or generalized dystonia; 3. Patients will have other movement disorders (Parkinson's disease, essential tremor, dyskinesia, myoclonus) and other non-neurological conditions (tic disorders, torticollis, ulnar nerve entrapments, temporomandibular disorders, dysphonia) that mimic dystonic symptoms. Exclusion criteria: 1. Patients who are incapable of giving informed consent; 2. Patients who are unable to undergo brain MRI due to the presence of certain tattoos and ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve) that cannot be removed or due to pregnancy or breastfeeding at the time of the study.
Where this trial is running
Boston, Massachusetts
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kristina Simonyan, MD, PhD — Massachusetts Eye and Ear
- Study coordinator: Kristina Simonyan, MD, PhD
- Email: simonyan_lab@meei.harvard.edu
- Phone: 617-573-6016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.