RECRUITING

In-patient SCC TMS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.

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

Quick Facts

Study Start:2025-04-01

Study Completion:2027-02-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05645575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. All subjects must be between 18-65 years of age. 2. 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. 3. Failure to respond to a minimum of 2 trials of antidepressant medication 4. Failure to respond from at least two different agent classes 5. Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count). 6. Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration. 7. Subjects are willing and able to adhere to the accelerated treatment schedule.	8. Are mentally or legally incapacitated, unable to give informed consent 9. Have an infection or poor skin condition over the scalp where the device will be positioned 10. Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure 11. Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode. 12. 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. 13. 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.)

Inclusion Criteria

Exclusion Criteria

1. All subjects must be between 18-65 years of age.
2. 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.
3. Failure to respond to a minimum of 2 trials of antidepressant medication
4. Failure to respond from at least two different agent classes
5. Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
6. Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
7. Subjects are willing and able to adhere to the accelerated treatment schedule.

8. Are mentally or legally incapacitated, unable to give informed consent
9. Have an infection or poor skin condition over the scalp where the device will be positioned
10. Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
11. Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
12. 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.
13. 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.)

Contacts and Locations

Study Contact

Nikita Vincecruz, BS

CONTACT

310-825-4781

nvincecruz@mednet.ucla.edu

Study Locations (Sites)

UCLA TMS Service and Research Service

Los Angeles, California, 90024

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2027-02-22

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2027-02-22

Terms related to this study

Additional Relevant MeSH Terms

Major Depressive Disorder