Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT05317390
Status
Recruiting

Conditions

  • Drug Induced Dystonia
  • Dyskinesias
  • Dysphonia
  • Dystonia
  • Essential Tremor
  • Myoclonus
  • Parkinson Disease
  • Temporomandibular Joint Disorders
  • Tic Disorders
  • Torticollis
  • Ulnar Nerve Entrapment

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • DystoniaNet-based diagnosis of isolated dystonia — DIAGNOSTIC_TEST
    DystoniaNet will be used for the diagnosis of dystonia and its differential diagnosis from other neurological and non-neurological disorders mimicking symptoms of dystonia

Study Details

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

Key Dates

Start date
Jun 1, 2022
Status verified
Nov 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114
Kristina Simonyan, MD, PhD
617-573-6016

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