RECRUITING

Pain and Major Depressive Disorder

Conditions

Major Depressive Disorder Chronic Pain TMS MDD

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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

This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.

Official Title

Multi-target Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Major Depressive Disorder (MDD) and Comorbid Pain

Quick Facts

Study Start:2023-03-01

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04556890

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 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* All Subjects must be between 18-75 years of age * Language: Participants must speak English fluently, as demonstrated by verbal skills sufficient to answer questions at a level that assures adequate understanding of the study * All subjects must be right-handed * Must have confirmed diagnosis of moderate Major Depressive Disorder (single or recurrent episode), minimum score of 17 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). No minimal MDD duration necessary for study participation * 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\* * Must have a confirmed FM or ME/CFS diagnoses and moderate pain complaints, minimum score of 15 on the McGill Pain Questionnaire. * Pain chronicity for at least 3 months prior to study enrollment. * Subjects are willing and able to adhere to the treatment schedule and required study visits.	* Are mentally or legally incapacitated, unable to give informed consent. * Are pregnant. * Have an active suicidal intent or plan. * Have had prior Transcranial Magnetic Stimulation treatment. * 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. * Psychotic depression or other 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 metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, 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

* All Subjects must be between 18-75 years of age
* Language: Participants must speak English fluently, as demonstrated by verbal skills sufficient to answer questions at a level that assures adequate understanding of the study
* All subjects must be right-handed
* Must have confirmed diagnosis of moderate Major Depressive Disorder (single or recurrent episode), minimum score of 17 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). No minimal MDD duration necessary for study participation
* 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\*
* Must have a confirmed FM or ME/CFS diagnoses and moderate pain complaints, minimum score of 15 on the McGill Pain Questionnaire.
* Pain chronicity for at least 3 months prior to study enrollment.
* Subjects are willing and able to adhere to the treatment schedule and required study visits.

* Are mentally or legally incapacitated, unable to give informed consent.
* Are pregnant.
* Have an active suicidal intent or plan.
* Have had prior Transcranial Magnetic Stimulation treatment.
* 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.
* Psychotic depression or other 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 metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, 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

Doan Ngo, BS

CONTACT

310-825-7797

thucdoanngo@mednet.ucla.edu

Juliana Corlier, PhD

CONTACT

jcorlier@ucla.edu

Study Locations (Sites)

UCLA Semel Institute

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 Date2023-03-01

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

TMS
MDD
Chronic Pain

Additional Relevant MeSH Terms

Major Depressive Disorder
Chronic Pain