Major Depressive Disorder, Multiple Sclerosis, Treatment Resistant Depression
Conditions
Keywords
multiple sclerosis, depression, major depressive disorder, treatment resistant depression, transcranial magnetic stimulation, TMS
Brief summary
The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment.
Detailed description
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. Depression, or major depressive disorder, is highly prevalent in people with MS and often has a serious impact on quality of life. MDD can be difficult to treat with medications in MS. Transcranial magnetic stimulation (TMS) is a safe and approved treatment for treatment-resistant depression in the general population. However, little is known about the use of TMS for MDD in people with MS. This pilot study will evaluate the safety, feasibility, and preliminary efficacy of TMS for MDD in MS. Participants will receive outpatient neuronavigated-TMS for MDD. Various measures of MS and MDD symptoms will be monitored over the course of treatment. Clinical brain imaging will also be compared before and after TMS.
Interventions
None listed
Sponsors
University of Utah
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Established diagnosis of multiple sclerosis (any subtype) by 2017 McDonald criteria * Established diagnosis of major depressive disorder (MDD) by DSM-5 criteria * Eligible for transcranial magnetic stimulation (rTMS) for depression
Exclusion criteria
* MS relapse and/or steroid use within 3 months * Active suicidal ideation * History of seizure/epilepsy, brain tumor, or stroke * History of bipolar disorder or psychosis * Currently or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of TMS treatment for MDD, per participant retention rates. | 10 weeks |
| Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment. | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment. | 10 weeks |
| Depression remission rates will be measured using MADRS scores before and after treatment. | 10 weeks |
| MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden. | 1 year |
Countries
United States
Contacts
Primary ContactKathleen Shangraw, MD
Backup ContactTrieste Francis
Outcome results
None listed