Recruiting

TMS

Sponsor:

University of Utah

Code:

NCT06329414

Conditions

Multiple Sclerosis

Major Depressive Disorder

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Multiple Sclerosis

Major Depressive Disorder

Treatment Resistant Depression

Study ID

NCT06329414

Start date

Jan 16, 2024

Status verified date

Mar, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kathleen Shangraw, MD

8015832500kathleen.shangraw@hsc.utah.edu

Trieste Francis

trieste.francis@hsc.utah.edu

Locations

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Kathleen Shangraw, MD

801-583-2500

More Information

Sponsor

University of Utah

Last update posted

Mar 25, 2024

Last verified

Mar, 2024

Keywords

  • multiple sclerosis
  • depression
  • major depressive disorder
  • treatment resistant depression
  • transcranial magnetic stimulation
  • TMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2024-03-25.