Magnus Medical SAINT OLO trial
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.
If you are interested in participating in the Brainsway Study, please fill out the prescreening form here.
Need Help with your depression?
Are Your Current Medications Just Not Working?
Take Part in Our (FDA approved) Multicenter Study for Depression Treatment with the Brainsway Deep TMS System
Fermata is recruiting patients who suffer from Major Depressive Disorder (MDD) and have not responded to antidepressant therapies to participate in a clinical study. The study is designed to evaluate the effectiveness of a new, innovative and drug-free therapy using Brainsway’s Deep Transcranial Magnetic Stimulation (Deep TMS) device. The goal of the study is to compare a new investigational stimulation protocol to the FDA-cleared standard-of-care stimulation protocol. No one will receive sham or placebo treatment and participation is free of charge to all individuals.
What treatment would I receive?
All participants will be randomized into one of two groups: a treatment group and a control group. Participants in both groups will receive TMS with the Brainsway Deep TMS device. The treatment group will receive the investigational stimulation protocol; the control group will receive the FDA-cleared standard-of-care deep TMS stimulation protocol. The duration, frequency and treatment schedule will differ between both groups. Participants cannot choose if they are in the treatment or control group as group assignment is randomly generated. Regardless of treatment group, all patients will receive TMS at no cost.
How long is participation in the study?
Individuals in both groups will receive treatment over a course of 6 weeks.
Am I eligible?
You may be eligible to participate if you:
- Are between 22 and 68 years of age.
- Have a primary DSM-5 diagnosis of Major Depression
- Have a minimum of 1 and a maximum of 4 antidepressant trials in the current episode.
In addition, you may be eligible if you do not:
- Endorse any previous or current psychotic or bipolar disorder.
- Have an active alcohol or substance use disorder.
- Have a current diagnosis of post-traumatic stress disorder.
- Possess ferromagnetic metals implanted in the head or neck.
- Have a personal or family history of seizures, not including febrile or ECT-induced seizures.
Individuals who are pregnant or breastfeeding/chestfeeding are not eligible to participate in this study.
Additional Information
To view additional study details including complete inclusion/exclusion criteria, please visit the National Library of Medicine atclinicaltrials.gov/study/NCT06357832
