In-patient SCC TMS
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|ClinicalTrials.gov Identifier: NCT05645575|
Recruitment Status : Not yet recruiting
First Posted : December 9, 2022
Last Update Posted : December 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Open-label TMS||Not Applicable|
Repetitive Transcranial Magnetic Stimulation (rTMS) is an efficacious treatment for Major Depressive Disorder (MDD) and may hold therapeutic potential for suicidality, specifically. The clinical benefit of rTMS is thought to depend upon successful engagement of brain functional networks, which in turn depends on the preferred oscillatory frequency of the target network for that individual.
We have developed a novel interrogation method to identify the optimal individual stimulation frequency for each participant to enhance treatment response by maximizing the engagement of the functional brain networks. Our data suggest that stimulation at individualized frequencies results in about 50% better response for depression compared to the standard treatment of 10 Hz stimulation. Additionally, an accelerated administration of rTMS (a-rTMS) has been shown safe and tolerable, which is highly desirable in the context of a hospitalization.
We propose to use this approach to administer 25 sessions of individualized a-rTMS left dorsolateral prefrontal cortex (DLPFC) over a course of five days to obtain an accelerated relief of depression symptoms and reduce suicide risk. We will enroll 30 in-patients undergoing treatment in the Resnick Neuropsychiatric Hospital. Patients will first undergo a brief (10-15 min) magnetic resonance imaging (MRI) for the purpose of neuronavigation to the optimal anatomical site. Subsequently, a motor threshold will be identified to determine the optimal stimulation intensity. Patients will receive 5 a-rTMS sessions daily for five days with a minimum interval of 1 hour between sessions. In addition to establishing tolerability and acceptability of the intervention, our goal is to evaluate the preliminary efficacy for improving depressive and suicidality symptoms. We expect the treatment to be well tolerated, providing fast relief of depression and suicidal symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label Transcranial Magnetic Stimulation Treatment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Evaluating the Feasibility of Accelerated rTMS Treatment Delivered at Individual Resonant Frequencies for In-patient Subjects Suffering From Major Depressive Disorder|
|Estimated Study Start Date :||February 22, 2023|
|Estimated Primary Completion Date :||February 22, 2025|
|Estimated Study Completion Date :||February 22, 2026|
|Experimental: Open-label TMS||
Device: Open-label TMS
Customized, Open-Label Transcranial Magnetic Stimulation
Other Name: Transcranial Magnetic Stimulation
- Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit [ Time Frame: 2 Weeks (Baseline and Final Visit) ]Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.
- Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit. [ Time Frame: 2 Weeks (Baseline and Final Visit) ]Treatment efficacy as measured by change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit. This is a 9-item questionnaire with minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- All subjects must be between 18-65 years of age.
- Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher.
- Failure to respond to a minimum of 2 trials of antidepressant medication
- Failure to respond from at least two different agent classes
- Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
- Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
Subjects are willing and able to adhere to the accelerated treatment schedule.
- Are mentally or legally incapacitated, unable to give informed consent
- Have an infection or poor skin condition over the scalp where the device will be positioned
- Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
- Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
- Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
- Presence of an implanted magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05645575
|Contact: Nikita Vincecruz, BSfirstname.lastname@example.org|
|Responsible Party:||Andrew F. Leuchter, Director of the Neuromodulation Division at the Semel Institute, University of California, Los Angeles|
|Other Study ID Numbers:||
|First Posted:||December 9, 2022 Key Record Dates|
|Last Update Posted:||December 9, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Sharing is dependent on request by other researchers and relation to study condition and treatment. De-identified study data will be shared at the PI's discretion.|
Statistical Analysis Plan (SAP)
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Depressive Disorder, Major