What side effects are associated with this type of intervention?

Common treatments for dystonia include VMAT2 inhibitors like tetrabenazine, deutetrabenazine, and valbenazine. Tetrabenazine can cause sedation, akathisia, parkinsonism, and depressed mood, which generally resolve with dose adjustments. Deutetrabenazine and valbenazine have a longer duration of action and an improved side effect profile compared to tetrabenazine. Gabapentin, used for its anti-tremor effects, can cause sleepiness, dizziness, and gait unsteadiness. Topiramate, another option, may reduce limb tremor but is associated with a high rate of adverse effects, including cognitive impairment and weight loss.

What prior FDA approvals exist?

The FDA has approved several treatments for dystonia, including botulinum toxin injections (e.g., Botox, Dysport, Xeomin) which are commonly used to manage muscle contractions and spasms associated with the condition. Oral medications such as anticholinergics, benzodiazepines, and muscle relaxants are also used to alleviate symptoms. Additionally, deep brain stimulation (DBS) has been approved for severe cases of dystonia, providing significant symptom relief for some patients. These treatments aim to reduce muscle overactivity and improve quality of life for individuals with dystonia.

What other types of research exist?

Promising alternatives to the DystoniaNet Deep Learning Platform for dystonia patients in 2024 include: 1) Transcranial Magnetic Stimulation (TMS) for its potential in neuromodulation, 2) Deep Brain Stimulation (DBS) which has shown efficacy in treating various movement disorders including dystonia, and 3) advancements in pharmacological treatments targeting specific neurotransmitter pathways. Additionally, other AI-based diagnostic tools and platforms that leverage machine learning for improved diagnostic accuracy are also emerging as potential alternatives.

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Deep Learning Platform

DystoniaNet Diagnosis for Dystonia

N/A

Recruiting

Led By Kristina Simonyan, MD, PhD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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;

Patients with at least one form of dystonia, including focal dystonia (e.g., laryngeal, cervical, oromandibular, blepharospasm, focal hand, musicians), segmental dystonia, or generalized dystonia

Must not have

Patients who are incapable of giving informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to validate a computer program called DystoniaNet that helps doctors diagnose dystonia more accurately. It targets patients with isolated dystonia who often experience delays in diagnosis. The program uses artificial intelligence to learn from data and identify signs of the disorder, improving diagnosis speed and accuracy.

Who is the study for?

This trial is for individuals with various forms of dystonia or conditions that resemble dystonic symptoms, such as Parkinson's disease and essential tremor. It includes people of all ages, genders, and ethnic backgrounds. Those who can't give consent or have MRI-incompatible body modifications or devices are excluded.

What is being tested?

The study is testing DystoniaNet, a deep learning platform designed to diagnose isolated dystonia by analyzing medical data. The research will look back at past cases and also include new patients to validate the accuracy of this diagnostic tool.

What are the potential side effects?

Since this trial involves diagnosis rather than treatment, there are no direct side effects from interventions like medications. However, participants may experience discomfort or anxiety during the diagnostic procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a type of dystonia, such as in my neck, eyes, jaw, hand, or it affects my whole body.

Select...

I have a type of dystonia, such as in my neck, eyes, jaw, hand, or it's more widespread.

Select...

I have a type of dystonia, such as in my neck, eyes, jaw, hand, or it affects my whole body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent for my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correctness of clinical diagnosis of dystonia using the DystoniaNet algorithm

Time of clinical diagnosis of dystonia using the DystoniaNet algorithm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospective clinical validation of DystoniaNetExperimental Treatment1 Intervention

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

Group II: Retrospective clinical validation of DystoniaNetActive Control1 Intervention

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).

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for dystonia involves botulinum toxin (BoNT) injections, which work by blocking the release of acetylcholine at the neuromuscular junction, leading to temporary muscle relaxation and reduced spasticity. This is particularly important for dystonia patients as it helps alleviate muscle contractions and improve functional abilities. Accurate diagnosis, as facilitated by platforms like DystoniaNet, ensures that patients receive appropriate and timely treatment, optimizing outcomes and enhancing quality of life.