Clinical trial NCT06329414: Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis
Official title: Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Major Depressive Disorder
Treatment Resistant Depression
Keywords: multiple sclerosis
depression
major depressive disorder
treatment resistant depression
transcranial magnetic stimulation
TMS
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with MDD and MS who are eligible for 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of TMS treatment for MDD, per participant retention rates.
timeFrame: 10 weeks
measure: Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment.
timeFrame: 10 weeks
Secondary outcomes:
measure: Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment.
timeFrame: 10 weeks
measure: Depression remission rates will be measured using MADRS scores before and after treatment.
timeFrame: 10 weeks
measure: MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden.
timeFrame: 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
References: