Effects of Accelerated rTMS on Cognitive Function

Summary

Cognitive impairment, including mild cognitive impairment (MCI) and mild dementia, is a growing public health challenge with limited effective treatment options. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown promise for improving cognitive function, but most studies have used conventional protocols and relied on global screening tools that may not capture domain-specific changes.

The purpose of this study is to evaluate the efficacy and tolerability of repetitive transcranial magnetic stimulation (rTMS) delivered via the EXOMIND™ device (BTL-699-2) for improving cognitive function in adults aged 50 to 90 years with mild to moderate cognitive impairment. The study asks whether a course of 6 rTMS sessions targeting the left dorsolateral prefrontal cortex, administered twice weekly over approximately 3 weeks, can produce meaningful and sustained improvements in global and domain-specific cognitive function over a 3-month follow-up period.

This is a single-center, open-label, prospective pilot study enrolling 80 participants with documented cognitive decline (Montreal Cognitive Assessment \[MoCA\] score 10-25). Participants will receive 6 sessions of high frequency rTMS (6,300 pulses per session at alternating frequencies of 12, 15, and 18 Hz) over approximately 3 weeks. The primary outcome is the change from baseline in MoCA score at 1-month follow-up. Secondary outcomes include changes in MoCA score at post-treatment and 3-month follow-up, changes in domain-specific cognitive measures (visual spatial working memory, episodic memory, deductive reasoning, mental rotation, verbal short term memory, and attention) assessed by the Creyos cognitive battery, and changes in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). Assessments are performed at baseline, post treatment, 1-month follow-up, and 3-month follow-up. Total study duration per participant is up to 139 days.

Conditions

• Cognitive Decline
• Cognitive Impairment

Interventions

DEVICE

TMS

The EXOMIND™ (BTL-699-2) is a repetitive transcranial magnetic stimulation (rTMS) device that delivers targeted electromagnetic pulses to cortical brain regions. In this study, stimulation is applied to the left dorsolateral prefrontal cortex (DLPFC), a region implicated in executive function, working memory, and attention. The DLPFC target is localized using the standard 5-cm rule, measured anterior to the motor cortex hot spot. Each treatment session uses a multi-frequency protocol alternating between 12, 15, and 18 Hz stimulation frequencies, delivering a total of 6,300 pulses over 24 minutes and 30 seconds. Stimulation intensity is calibrated to each participant's resting motor threshold, defined as the minimum stimulus intensity required to produce a visible contraction of the right abductor pollicis brevis muscle. Six sessions are administered twice weekly over approximately 3 weeks. The procedure is performed on

Sponsors & Collaborators

• San Francisco Neurology and Sleep Center

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-11-01

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations