Pain and Major Depressive Disorder

NCT04556890 | Recruiting FDA Device

• 1 other identifier: 20-000530
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Chronic Pain

Keywords

TMS; MDD; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Percent change in depression scores

  Inventory of Depressive symptoms- Self (IDS-SR) scores will be analyzed as the primary outcome measure. The IDS-SR is a 30-item scale that measures various symptoms of depression. Each item is scored between 0-4. Severity of depression is associated with a higher score with scores ranging from 0 to 84.

  Through study completion, an average of 6 weeks

• Percent change in pain score

  McGill Pain questionnaire (MPQ) will be analyzed as the secondary outcome. MPQ is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain and effectiveness of an intervention. Scoring ranges from 0 to 78. A higher score is associated with greater pain.

  Through study completion, an average of 6 weeks

Secondary Outcomes (1)

• Levels of inflammatory markers and transcription factors

  Through study completion, average of 6 weeks

Study Arms (2)

Active rTMS/Active iTBS DFPLC/Sham Pain M1

EXPERIMENTAL

Device: Active rTMS/Active iTBS DFPLC/Sham Pain M1

Active rTMS/Active iTBS

EXPERIMENTAL

Device: Active rTMS/Active iTBS

Interventions

Active rTMS/Active iTBS DFPLC/Sham Pain M1 DEVICE

Active rTMS treatment for depression (600 pulses of active intermittent theta burst (iTBS) administrated at 120% MT to the left DLPFC) and sham treatment for pain at M1

Active rTMS/Active iTBS DFPLC/Sham Pain M1

Active rTMS/Active iTBS DEVICE

Active rTMS treatment for both, depression and pain (600 pulses of iTBS to left DLPFC followed by 600 iTBS + 1500 pulses of 10 Hz to M1

Active rTMS/Active iTBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90024, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Chronic Pain

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Doan Ngo, BS

CONTACT

310-825-7797; thucdoanngo@mednet.ucla.edu

Juliana Corlier, PhD

CONTACT

jcorlier@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All stimulation procedures will be double-blinded, with clinicians, raters and patients blinded to the type of administered treatment using a designated sham coil.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study design includes two different stimulation protocols consisting each of 30 sessions: A) Active rTMS treatment for depression (1800 pulses of active intermittent theta burst (iTBS) administrated at 120% MT to the left DLPFC) and sham treatment for pain at M1; B) Active rTMS treatment for both, depression and pain (1800 pulses of iTBS to left DLPFC followed by 1500 pulses of 10 Hz to M1)

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 21, 2020
• Study Start: March 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)