Changeflow GovPing Healthcare & Life Sciences Effects of Accelerated rTMS on Cognitive Function
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Effects of Accelerated rTMS on Cognitive Function

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Summary

A single-center, open-label, prospective pilot study registered as NCT07547319 on ClinicalTrials.gov, evaluating the efficacy and tolerability of accelerated repetitive transcranial magnetic stimulation (rTMS) delivered via the EXOMIND™ device (BTL-699-2) for improving cognitive function. The study will enroll 80 adults aged 50-90 years with mild to moderate cognitive impairment (MoCA score 10-25), administering 6 sessions of high-frequency rTMS (6,300 pulses per session at alternating 12, 15, and 18 Hz frequencies) targeting the left dorsolateral prefrontal cortex over approximately 3 weeks. The primary outcome is change from baseline in MoCA score at 1-month follow-up, with a 3-month extended follow-up period to assess sustained cognitive improvements.

“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.”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

A new clinical trial registration (NCT07547319) for a pilot study evaluating accelerated rTMS delivered via the EXOMIND™ device (BTL-699-2) has been listed on ClinicalTrials.gov. The study targets adults aged 50-90 with mild to moderate cognitive impairment (MoCA score 10-25) and will assess whether 6 sessions of high-frequency rTMS (6,300 pulses per session at alternating 12, 15, and 18 Hz) can produce meaningful and sustained cognitive improvements over a 3-month follow-up period. The primary endpoint is change in MoCA score from baseline at 1-month follow-up.

Medical device manufacturers and clinical research organizations should note this trial registration for awareness. The study uses an identified device (BTL-699-2) and specifies a single-center, open-label design. No compliance obligations are created by this registration; it is an informational listing of a planned clinical investigation.

Archived snapshot

Apr 23, 2026

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Effects of Accelerated rTMS on Cognitive Function

N/A NCT07547319 Kind: NA Apr 23, 2026

Abstract

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-t...

Conditions: Cognitive Decline, Cognitive Impairment

Interventions: TMS

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
NCT07547319

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical trial registration Neuromodulation therapy research
Threshold
80 participants; adults aged 50-90 years with MoCA score 10-25
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Healthcare

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