Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis; Major Depressive Disorder; Treatment Resistant Depression

• Registration Number: NCT06329414
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2024-01-16
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment.	10 weeks
Feasibility of TMS treatment for MDD, per participant retention rates.	10 weeks

Secondary Outcome Measures

Name	Time	Method
MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden.	1 year
Depression remission rates will be measured using MADRS scores before and after treatment.	10 weeks
Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment.	10 weeks

Trial Locations

Locations (1)

University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States