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Not recruiting

Neuromodulation

Sponsor:

University of New Mexico

Code:

NCT04543773

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

rTMS

Study Details

Brief 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.

Conditions

Major Depressive Disorder

Study ID

NCT04543773

Start date

Oct 1, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rTMS

Subjects will receive rTMS to the area of the DLPFC most anticorrelated with the ACC.

Interventions

rTMS

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.

Primary outcome measure

  • Anterior Cingulate Cortex (ACC) Connectivity [ Time Frame: Week 3 post-treatment assessment ]

Central Contacts and Locations

Central contacts

Locations

University of New Mexico HSC

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Davin Quinn, MD

More Information

Sponsor

University of New Mexico

Last update posted

Feb 7, 2025

Last verified

Feb, 2025

Keywords

  • depression
  • geriatric
  • rTMS
  • fMRI
  • neuronavigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of New Mexico on 2025-02-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.