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

NCT ID: NCT06329414

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-16

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Major Depressive Disorder Treatment Resistant Depression

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Shangraw

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah Health

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Shangraw, MD

Role: CONTACT

8015832500

Trieste Francis

Role: CONTACT

Facility Contacts

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Kathleen Shangraw, MD

Role: primary

801-583-2500

Other Identifiers

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00164631

Identifier Type: -

Identifier Source: org_study_id

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