Recruiting

DystoniaNet

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT05317390

Conditions

Dystonia

Drug Induced Dystonia

Parkinson Disease

Essential Tremor

Dyskinesias

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

DystoniaNet-based diagnosis of isolated dystonia

Study Details

Brief summary:

This research involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia.

Conditions

Dystonia

Drug Induced Dystonia

Parkinson Disease

Essential Tremor

Dyskinesias

Study ID

NCT05317390

Start date

Jun 1, 2022

Status verified date

Nov, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Retrospective clinical validation of DystoniaNet

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).

experimental: Prospective clinical validation of DystoniaNet

Prospective randomized studies will validate DystoniaNet performance for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting.

Interventions

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

Primary outcome measure

  • Correctness of clinical diagnosis of dystonia using the DystoniaNet algorithm [ Time Frame: 4 years ]
  • Time of clinical diagnosis of dystonia using the DystoniaNet algorithm [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts Eye and Ear Infirmary

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2025-12-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.