SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression

Part of paid clinical trials in Costa Mesa, California.

Sponsor
BrainHealth Solutions, Inc.
Study ID
NCT07876908
Status
Recruiting
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Conditions

  • Depressive Disorder, Treatment-Resistant
  • Memory Deficits

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System — DEVICE
    MRI-guided, individualized accelerated intermittent theta-burst stimulation delivered with the Magnus Neuromodulation System to a personalized left dorsolateral prefrontal cortex target. Participants receive 10 stimulation sessions per day for 5 consecutive days (50 total sessions). Each 10-minute session delivers 1,800 magnetic pulses at 90% of motor threshold with depth adjustment, using 50-Hz triplet bursts at 5 Hz (2-second trains, 8-second inter-train intervals). Sessions are separated by approximately 50 minutes. Total planned exposure is 90,000 pulses. Participants wear hearing protection during stimulation.

Study Details

The goal of this clinical trial is to learn whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®), a type of transcranial magnetic stimulation (TMS), is safe and may improve memory and thinking in adults aged 65 or older with treatment-resistant depression and memory concerns. Researchers will also study whether SAINT® improves depression symptoms. The main questions it aims to answer are: * Does SAINT® improve memory and thinking five days after treatment? * Does SAINT® improve depression symptoms and overall well-being? * Do changes in memory, mood, or daily activities last for up to one year? * What side effects or safety concerns occur during and after treatment? All participants will receive SAINT® treatment. There is no placebo group. Participants will: * Complete memory, mood, and health assessments and have an MRI scan * Receive 10 TMS sessions each day for 5 days in a row * Return for follow-up visits for up to 12 months Researchers will track changes in memory, mood, daily activities, and side effects.

Key Dates

First listed
Oct 15, 2026
Start date
Oct 1, 2026
Status verified
Oct 2026
Primary completion
Jan 1, 2029
Completion
Feb 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SAINT® Neuromodulation Treatment

Primary Outcome Measure

Change From Baseline in Mini-Mental State Examination (MMSE) Score at 5 Days Post-Stimulation [ Time Frame: Baseline and 5 days after completion of SAINT stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BrainHealth Solutions Inc.Costa MesaCalifornia92626
Melissa Perez
[email protected]
949-241-0898
Daniela Bota
[email protected]
229-815-0230

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By research site
BrainHealth Solutions Inc.· Costa Mesa, CA

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