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Brain Stimulation for Depression
Study Summary
This trial is testing a new method of treatment for severely depressed patients who have not responded to other treatments. A small electrode will be placed in the skull and intermittently activated to modulate brain regions. The goal is to decrease depression symptoms. Up to 20 subjects will be enrolled and followed for up to one year.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- The surgical or medical risk for the patient is too high if they undergo the investigational procedure.You have a history of bone disorders that may affect the safety and effectiveness of using the device or getting a device implant.You have had a brain injury in the past that has affected your thinking abilities.You might need to undergo a complete body MRI scan during the study.You have been diagnosed with long-term or repeated depression, and are currently going through a severe episode of depression.You have a baseline score of 20 or higher on a test that measures your level of depression symptoms.You have a history of severe mental disorders like schizophrenia or schizoaffective disorder, or you are currently experiencing a major depressive episode with psychotic features.You have a brain condition like epilepsy, dementia, or problems with memory and thinking.
- Group 1: Intervention, Placement of Device & Stimulation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Am I qualified to take part in this research endeavor?
"This trial aims to enroll 20 individuals suffering from depression and aged between 21 and 80. They must satisfy the following conditions: Written consent for participation, diagnosis of chronic/recurrent depression with a MADRS score >/=20, no sustained response to two or more antidepressant treatments classes in their current depressive episode, completion of all baseline tests prior to implant surgery (including CT & MRI brain scans), women not pregnant nor capable of becoming pregnant; age range is 21-80 years old; able to complete evaluation including high resolution CT & MRI imaging."
Is this research endeavor welcoming persons aged 45 or above as participants?
"This clinical trial dictates that participants must be between 21 and 80 years old. In contrast, there are 193 trials recruiting those under 18 while 967 studies focus on patients above the age of 65."
Are there any openings for prospective patients to join this clinical exploration?
"Data hosted on clinicaltrials.gov shows that this trial is no longer recruiting for new participants, with the original post dating back to June 1st 2022 and last updated on May 23rd 2022. Nevertheless, there are over 1296 other trials currently open for patient recruitment at present."
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