Multiple SclerosisNCT06329414
Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis
An observational study of Multiple Sclerosis and Major Depressive Disorder, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Major Depressive Disorder, Treatment Resistant Depression
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 10 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with MDD and MS who are eligible for TMS
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health
Salt Lake City, Utah, 84108
About this study
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.
Read the 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.
- Keywords
- multiple sclerosis, depression, major depressive disorder, treatment resistant depression, transcranial magnetic stimulation, TMS
- Medical subject headings
- Multiple Sclerosis, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of TMS treatment for MDD, per participant retention rates.
Measured: 10 weeks
Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment.
Measured: 10 weeks
Secondary outcomes (3)
Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment.
Measured: 10 weeks
Depression remission rates will be measured using MADRS scores before and after treatment.
Measured: 10 weeks
MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start16 Jan 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Why it stopped: Recruitment Failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329414
- Sponsor's protocol ID
- 00164631
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06329414
- Acronym / sponsor ID
- 00164631
- Keywords
- multiple sclerosis, depression, major depressive disorder, treatment resistant depression, transcranial magnetic stimulation, TMS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment Failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with MDD and MS who are eligible for TMS
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment.
Time frame: 10 weeks
Depression remission rates will be measured using MADRS scores before and after treatment.
Time frame: 10 weeks
MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Major Depressive Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of TMS treatment for MDD, per participant retention rates. (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.