Recruiting

Pain & Depression

Sponsor:

UCLA

Code:

NCT04556890

Conditions

Major Depressive Disorder

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active rTMS/Active iTBS DFPLC/Sham Pain M1

Active rTMS/Active iTBS

Study Details

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

Study ID

NCT04556890

Start date

Mar 1, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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
  • 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.

Exclusion Criteria:

  • 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)

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: Active rTMS/Active iTBS

Interventions

Active rTMS/Active iTBS DFPLC/Sham Pain M1

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

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

Primary outcome measure

  • Percent change in depression scores [ Time Frame: Through study completion, an average of 6 weeks ]
  • Percent change in pain score [ Time Frame: Through study completion, an average of 6 weeks ]

Central Contacts and Locations

Central contacts

Doan Ngo, BS

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

Juliana Corlier, PhD

jcorlier@ucla.edu

Locations

UCLA Semel Institute

Recruiting

Los Angeles, California, United States, 90024

Contacts

THUC-DOAN NGO, BS

3108257797thucdoanngo@mednet.ucla.edu

Principal Investigator:

Juliana Corlier, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • TMS
  • MDD
  • Chronic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-08-11.