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Pain and Major Depressive Disorder

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 33 visits
  • Procedures mentioned: Blood draws, MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how transcranial magnetic stimulation, which uses magnets to stimulate the brain, affects pain linked to major depression. It is for adults with depression that has not improved with treatment and who also have fibromyalgia or ME/CFS. Everyone gets active treatment, with 30 treatments over 30–33 study visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–75 years old and speak English well enough to understand the study and answer questions.
  • You have confirmed moderate major depression and score at least 17 on the study’s depression rating scale.
  • Your depression has not improved after trying at least 2 antidepressants from 2 different drug groups.
  • You have also tried at least 2 proven add-on treatments for depression. Benzodiazepines, a type of calming medicine, do not count.
  • You have tried a proven talk therapy for depression often enough and for long enough.
  • You have confirmed fibromyalgia, a condition that causes widespread pain, or ME/CFS, a condition that causes severe, lasting tiredness.
  • You have had pain for at least 3 months, with moderate pain and a score of at least 15 on the McGill Pain Questionnaire.
  • You are willing and able to follow the treatment schedule and attend the required visits.

Who can't join

  • You cannot give informed consent, meaning you cannot understand and agree to join, or cannot legally give consent.
  • You are pregnant or currently have an intent or plan to end your life.
  • You have had transcranial magnetic stimulation before.
  • You have an infection or poor skin condition on the scalp where the device would sit.
  • You have a higher risk of seizures because of family history, stroke, or medicines you take.
  • During your current depression, you have psychosis, such as seeing or hearing things that are not there, or a disorder such as schizophrenia.
  • You have certain brain or nerve conditions, including epilepsy, blood vessel disease in the brain, dementia, high pressure inside the skull, repeated or severe head injuries, or brain or spinal cord tumors.
  • You have an implanted metal or magnet-sensitive medical device, such as a pacemaker, hearing implant, medicine pump, or certain metal clips or stents. Metal dental fillings are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA