Brain Stimulation for Cognitive Functioning

Overseen By Michael Thomas, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Must not be taking: Brain excitability drugs

Disqualifiers: Seizures, Epilepsy, Neurological, Psychiatric, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how brain stimulation affects thinking and memory using a technique called Transcranial Magnetic Stimulation (TMS). TMS involves using magnetic fields to gently stimulate the brain. Participants are divided into two groups: one receives real TMS, while the other receives a sham version that does not affect the brain. Right-handed, English-speaking individuals with no history of seizures or major medical issues may be suitable for this trial. As an unphased trial, participants contribute to groundbreaking research and help advance the understanding of brain stimulation effects.

Do I have to stop taking my current medications for the trial?

You may need to stop taking medications that increase brain excitability, as they are listed in the exclusion criteria. The trial does not specify other medication restrictions, so it's best to discuss your current medications with the study team.

What prior data suggests that transcranial magnetic stimulation is safe for cognitive functioning?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe and well-tolerated. Studies have found that TMS does not cause seizures or memory loss, unlike treatments such as electroconvulsive therapy. It also doesn't require anesthesia, which many people find beneficial.

Other research indicates that TMS is safe when used according to guidelines. Serious side effects are rare, and most people experience only mild and temporary side effects, if any. This makes TMS a promising option for further development and use.

Overall, TMS has a good safety record, making it suitable for use in clinical trials like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, potentially improving cognitive functioning. Unlike traditional medications for cognitive issues, which often work by altering chemical balances in the brain, TMS offers a non-invasive and targeted approach. Researchers are excited about TMS because it can be precisely directed to specific areas of the brain, potentially leading to fewer side effects and offering hope for those who haven't responded to other treatments. Additionally, the sham TMS acts as a placebo, helping researchers understand the actual impact of the active TMS compared to no real brain stimulation.

What evidence suggests that transcranial magnetic stimulation is effective for cognitive functioning?

Research has shown that transcranial magnetic stimulation (TMS) can improve thinking and memory skills. In this trial, participants may receive Active TMS, which involves repetitive TMS for the brain. One study found that TMS significantly boosted memory and language abilities in people with Alzheimer's disease. Another study demonstrated that TMS led to noticeable improvements in overall brain function compared to those who did not receive the treatment. TMS has also proven effective for people with mild cognitive impairment and Alzheimer's, offering both short-term and lasting benefits. Overall, TMS is considered safe and shows great potential in enhancing cognitive abilities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking individuals without significant medical or neurological issues. It excludes those with a history of severe headaches, syncope, head injuries, psychiatric disorders, substance abuse, hearing/visual impairments affecting cognition, metal implants in the head/neck (except dental), and certain medical devices.

Inclusion Criteria

Right-handed

Fluent in English

Exclusion Criteria

History of implanted neurostimulator

Inadequate sleep in the 48 hours prior to TMS

History of metal in the head or neck (except braces and fillings)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants complete cognitive tasks while active versus sham TMS is applied to the brain

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

No follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study is testing how Transcranial Magnetic Stimulation (TMS) affects cognitive task performance. Researchers are looking to find the best parameters for using TMS to measure its impact on cognitive functions.

How Is the Trial Designed?

Group I: Active TMS Experimental Treatment 1 Intervention

Repetitive TMS for the brain

Group II: Sham TMS Placebo Group 1 Intervention

Scalp stimulation that does not affect the brain.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5464918/

Repetitive transcranial magnetic stimulation improves ... In conclusion, our findings suggested that repetitive transcranial magnetic stimulation improves cognitive function, memory and language level of AD patients, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725000230

Effects of repetitive transcranial magnetic stimulation (rTMS ... The meta-analysis revealed no significant improvement in cognitive impairment with active rTMS compared to sham rTMS across multiple cognitive ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1209205/full

Transcranial magnetic stimulation effects on cognitive ... Conclusion: Cognitive improvement effect of TMS was demonstrated in MCI and AD patients in both short-term assessment and long-lasting outcomes, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37526325/

Does repetitive transcranial magnetic stimulation improve ... The results from the random-effects meta-analysis showed rTMS significantly improved global cognitive function relative to control groups shown by a large, ...

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02493-8

Therapeutic potential and mechanisms of repetitive ... Existing studies have confirmed that transcranial magnetic therapy is both safe and effective, demonstrating significant improvement in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation And, unlike electroconvulsive therapy (ECT), rTMS doesn't cause seizures or memory loss. It also doesn't require the use of anesthesia, which ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306417/

Efficacy and Safety of Transcranial Magnetic Stimulation on ... TMS was safe and well tolerated with infrequent serious adverse events. Keywords: cognition, dementia, meta-analysis, MCI, mild cognitive ...

9. academic.oup.com academic.oup.com/ijnp/article/11/1/131/647218

A review of the safety of repetitive transcranial magnetic ... When given within recommended guidelines, the overall safety profile of rTMS is good, and supports its further development as a clinical treatment. Clinical ...

10. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1177594/full

Therapeutic effects of repetitive transcranial magnetic ... The current analysis of the evidence suggests that rTMS safely and effectively promotes cognitive recovery in patients with PSCI, with a few transient adverse ...