Accelerated rTMS for Cognitive Decline
This study is looking at how a treatment called repetitive transcranial magnetic stimulation (rTMS) using the EXOMIND™ (BTL-699-2) device might help improve thinking skills in people with mild to moderate cognitive impairment. rTMS uses magnetic pulses to stimulate specific areas of the brain. The study will focus on stimulating the left dorsolateral prefrontal cortex (DLPFC), a brain area important for executive function. Researchers want to see if this treatment can improve cognitive function, measured by changes in the Montreal Cognitive Assessment (MoCA) score after one month. You may be able to join if you are between 50 and 90 years old and have documented cognitive decline, such as a MoCA score between 10 and 25 or a diagnosis of mild cognitive impairment. The study aims to enroll 80 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 80 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in their cognitive function for one month after the treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07547319
Effects of Accelerated rTMS on Cognitive Function
Recruiting
NAAges 50–90InterventionalTreatmentSan Francisco Neurology and Sleep CenterInvestigator-initiated
~80 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:TMS
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in the Montreal Cognitive Assessment (MoCA) score at 1-month follow-up.
Measured over From baseline to the 1-month follow up
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent.
Documented cognitive function decline, defined as:
Ability to provide written informed consent, or availability of a legally authorized representative to provide consent.
Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Sufficient visual and auditory acuity to complete cognitive assessments.
Stable doses of any cognitive-enhancing medications (e.g., cholinesterase inhibitors, memantine) for at least 4 weeks prior to screening, with no anticipated changes during the study period.
Availability and willingness to complete all scheduled study visits.
Presence of a reliable study partner or caregiver who can provide information about the participant's cognitive and functional status.
Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb.
Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure during study participation.
Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation.
Willingness to comply with study instructions and to return to the clinic for the required visits.
Women of child-bearing potential are required to use birth control measures during the whole duration of the study.
Exclusion
Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.
Metallic, ferromagnetic, or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.
Drug pumps within 12 inches (30 cm) of the therapy coil.
Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the right thumb cannot be established).
History of seizure disorder or epilepsy, except for a single remote seizure more than 5 years ago, which may be permitted at investigator discretion.
Elevated risk of seizure due to traumatic brain injury with loss of consciousness \>30 minutes within the past 12 months.
Current use of medications known to significantly lower seizure threshold (e.g., clozapine, bupropion at doses \>450 mg/day, theophylline, high-dose tricyclic antidepressants) or recent dose reduction of anticonvulsant medications or benzodiazepines within 4 weeks of screening.
Severe dementia, defined as MoCA score below 10, or inability to follow simple verbal commands or complete basic cognitive assessments.
Rapidly progressive dementia (e.g., suspected prion disease, autoimmune encephalitis).
Brain tumor, intracranial hemorrhage within the past 12 months, arteriovenous malformation, or increased intracranial pressure.
Acute stroke within the past 3 months (stable chronic stroke with cognitive sequelae may be included at investigator discretion).
Has a current diagnosis of psychotic disorder, bipolar disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.
Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening.
History of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening, or positive test result(s) for drugs of abuse (including opiates, cocaine, cannabinoids, methamphetamines, amphetamines) at screening.
Has history of or current clinically significant and/or unstable medical condition that could interfere with study participation or pose safety concerns, including but not limited to:
Has uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg, despite diet, exercise, or a stable dose of antihypertensive therapy) at screening. A subject with hypertension may be included if the subject's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months.
Has clinically significant ECG abnormalities at screening, defined as:
Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.
Has received an investigational drug or used an invasive investigational medical device within 3 months before screening, or is currently enrolled in an investigational study.
Prior treatment with rTMS within 6 months of screening.
Subjects willing to partake in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure, during study participation.
Has psychological and/or emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
What this trial measures
- Change from baseline in the Montreal Cognitive Assessment (MoCA) score at 1-month follow-up.From baseline to the 1-month follow up
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total Score Range: 0 to 30. Interpretation: Higher scores indicate better cognitive function (a score of 26 or above is generally considered normal). Metric: The change is calculated by subtracting the baseline score from the 1-month follow-up score.