Individualized Targeting and Neuromodulation of Late-Life Depression

NCT04543773 | Active Not Recruiting FDA Device

• 1 other identifier: 19-531
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

depression; geriatric; rTMS; fMRI; neuronavigation

Outcome Measures

Primary Outcomes (1)

• Anterior Cingulate Cortex (ACC) Connectivity

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

  Week 3 post-treatment assessment

Secondary Outcomes (1)

• Depression Severity

  Week 3 post-treatment assessments

Study Arms (1)

rTMS

EXPERIMENTAL

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

Device: rTMS

Interventions

rTMS DEVICE

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.

rTMS

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant must be fluent in English
• 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
• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• The Mind Research Network: collaborator

Study Sites (1)

University of New Mexico HSC

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: September 10, 2020
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)