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Major Depressive DisorderTMS-LLDNCT04543773

Individualized Targeting and Neuromodulation of Late-Life Depression

A study testing rTMS in people with Major Depressive Disorder, run by University of New Mexico at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

An open-label, single-arm, clinical research study about how to make transcranial magnetic stimulation (TMS), an FDA-approved treatment, more effective for patients with late-life depression using fMRI. Read more about this study

Who is it for?
Ages 60 to 79 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
rTMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be at least 60 years of age (all genders, races, and ethnicities), and less than or equal to 79 years of age.
  • Participant must have a diagnosis of major depressive disorder without psychosis for the past 6 months, as diagnosed by a board-certified psychiatrist
  • Must show evidence of being in a current major depressive episode, as indicated by score on QIDS-C of 10 or higher.
  • Participant must not have any conditions listed in the exclusion criteria
  • Participant must be fluent in English

Who cannot join

  • Current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any other psychotic disorder
  • Substance use disorder, abuse or dependence, with active use within the last 3 months
  • Legal or mental incompetency, or inability to consent to study
  • Unstable medical illness, or hospitalization within 3 weeks of study entry
  • Current diagnosis of a neurological disorder or neurocognitive disorder
  • Prior neurosurgical procedure
Show all 12Show fewer
  • History of seizure
  • History of ECT treatment within the past three months
  • History of any previous TMS treatment
  • Any contraindication to obtaining magnetic resonance imaging safely
  • Pregnant women
  • Inability to complete the protocol, namely, inability to independently attend all study visits and TMS sessions on time.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico HSC

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

An open-label, single-arm, clinical research study about how to make transcranial magnetic stimulation (TMS), an FDA-approved treatment, more effective for patients with late-life depression using fMRI.

Read the detailed description

Approximately 10-15% of elderly persons will suffer from late life depression (LLD), which is often complicated by simultaneous cognitive impairment (so-called "pseudodementia" of depression). Unfortunately, the treatments for moderate to severe LDD have not changed significantly in the past sixty years, and are accompanied by either systemic side effects (antidepressant medications), or prominent memory loss (electroconvulsive therapy; ECT). Newer therapies such as transcranial magnetic stimulation (TMS) have a superior side effect profile, but lack robust efficacy in LLD (only 40% remission) compared to 60-80% remission rates with ECT. Moreover, few studies have attempted to measure target engagement of effective therapeutics for LLD, leading to critical gaps in understanding of the biological mechanisms underlying this disease. The long-term goal is to develop safer, more effective treatments for LLD that engage the brain's pathophysiology, improve functioning, and prolong quality of life.

Findings from the investigators' studies of structural and connectivity changes associated with depression treatment and others suggest that when noninvasive neurostimulation is precisely focused on specific neural circuits governing mood, more robust antidepressant results can be achieved. The brain region determined to have the greatest functional relevance in depression is the anterior cingulate cortex (ACC), with multiple imaging and stimulation studies over two decades supporting its crucial role. However, its mesial location makes direct stimulation difficult; consequently, TMS in its most common form attempts to modulate the ACC through a more superficial "cortical window," namely the dorsolateral prefrontal cortex (DLPFC). However, modest remission rates for TMS in LLD (<40%) may be related to the current practice of using external scalp landmarks to target the DLPFC, causing imprecision and inaccuracy in finding and accessing the true DLPFC.

Based on recent clinical trials and brain stimulation modeling methods developed in an ongoing study, the investigators propose a pilot study of structural and functional MRI (sfMRI) to identify individual-specific targets for TMS to treat LDD. A total of 24 elderly depressed patients recruited from the UNM Treatment Resistant Depression (TRD) Clinic and the Geriatric Psychiatry Clinic will undergo sfMRI and cognitive/behavioral assessment prior to TMS treatment. Utilizing analytical techniques already implemented in other studies, the investigators will identify each person's cortical "fingerprint" or hotspot in the DLPFC that demonstrates maximum functional anti-correlated connectivity with the ACC. The participants with LLD will each receive 30 sessions of TMS targeted to this functional network. Following the 15th and the 30th stimulation session, participants will repeat clinical and imaging assessments. Changes in depressive symptoms will be correlated with changes in connectivity, as well as the amount of induced electrical current projected to reach depression network nodes using finite element modeling methods. This precision medicine approach is crucial for reducing variability in the actual amount of delivered energy and will have a significant impact on efficacy, making TMS the "go-to" treatment of choice for LLD.

Being tested
rTMS
Keywords
depression, geriatric, rTMS, fMRI, neuronavigation
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMSDevice

    rTMS will be delivered to the fMRI-determined DLPFC hotspot according to conventional parameters for clinical treatment (e.g., excitatory: 75 trains of 40 pulses, 10Hz, up to 3000 pulses). Magnetic field strength will be up to 120% of resting motor threshold. Ramp up of magnetic field strength may be utilized in the first week for tolerability. Side effects will be monitored and coil angle adjusted to improve tolerability if necessary.

Study groups in NCT04543773
Study groupRoleWhat they receive
rTMSExperimentalSubjects will receive rTMS to the area of the DLPFC most anticorrelated with the ACC.
Receives: Device: rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anterior Cingulate Cortex (ACC) Connectivity

    Change in baseline correlation index of the ACC network on resting state fMRI

    Measured: Week 3 post-treatment assessment

Secondary outcomes (1)
  1. Depression Severity

    Change in baseline score on the Quick Inventory of Depressive Symptoms (QIDS) scale (min score 0, max score 27, higher scores indicate more severe depression)

    Measured: Week 3 post-treatment assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start1 Oct 2024
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04543773
Sponsor's protocol ID
19-531
Acronym
TMS-LLD
Status last verified
Oct 2026
First submitted
29 Jun 2020
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing rTMS in people with Major Depressive Disorder, run by University of New Mexico 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 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?

This study is still under way. Results are not available in the source record yet.

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?

Anterior Cingulate Cortex (ACC) Connectivity (time frame: Week 3 post-treatment assessment). 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 9 Oct 2026.

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