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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329414
• Other study ID #: 00164631
• Status: Recruiting
• Start date: January 16, 2024
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Kathleen Shangraw, MD
• Phone: 8015832500
• Email: kathleen.shangraw[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Multiple Sclerosis
• Sclerosis
• Treatment Resistant Depression

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of TMS treatment for MDD, per participant retention rates.		10 weeks
Primary	Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment.		10 weeks
Secondary	Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment.		10 weeks
Secondary	Depression remission rates will be measured using MADRS scores before and after treatment.		10 weeks
Secondary	MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden.		1 year