Effects of Accelerated rTMS on Cognitive Function

Part of paid clinical trials in San Francisco, California.

Sponsor
San Francisco Neurology and Sleep Center
Study ID
NCT07547319
Status
Not Yet Recruiting

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Conditions

  • Cognitive Decline
  • Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS — DEVICE
    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

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Nov 1, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Active Comparator: rTMS Treatment
    Participants receive 6 sessions of repetitive transcranial magnetic stimulation (rTMS) using the EXOMIND™ device (BTL-699-2), administered twice weekly over approximately 3 weeks. Each session delivers 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz to the left dorsolateral prefrontal cortex (DLPFC), localized using the 5-cm rule, with a total session duration of 24 minutes and 30 seconds. Motor threshold is individually determined as the minimum stimulus intensity required to induce contraction of the right thumb. Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA) and the Creyos cognitive battery at baseline, post-treatment (Day 21), 1-month follow-up (Day 51 ± 7), and 3-month follow-up (Day 111 ± 7). Depressive symptoms are assessed using the PHQ-9 at each time point. Adverse events and vital signs are monitored throughout.

Primary Outcome Measure

Change from baseline in the Montreal Cognitive Assessment (MoCA) score at 1-month follow-up. [ Time Frame: From baseline to the 1-month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Neurology and Sleep CenterSan FranciscoCalifornia94108
Joy Shihui Meng, MD
[email protected]
415-666-2536
Junyi Sun, MD, PhD
[email protected]
415-666-2536
Joy Shihui Meng, MD (PRINCIPAL_INVESTIGATOR)
Junyi Sun, MD, PhD (SUB_INVESTIGATOR)

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