Transcranial Magnetic Stimulation for Episodic Memory

Overseen By Maureen Ritchey, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston College

Must not be taking: Tricyclics, Neuroleptics, Centrally-acting drugs

Disqualifiers: Psychiatric illness, Neurological disorder, Heart disease, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain brain areas assist with memory using transcranial magnetic stimulation (TMS), a technique that uses magnetic fields to stimulate brain activity. The goal is to observe how TMS affects memory and brain interactions in healthy young adults. Suitable participants have no major neurological or psychiatric illnesses, are right-handed, and have normal vision. As an unphased trial, participants contribute to groundbreaking research that enhances understanding of brain function and memory.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that lower the seizure threshold, such as certain antidepressants and neuroleptic agents. Additionally, you should not use centrally-acting medications or drugs, except caffeine, within the last 12 hours before participation.

What prior data suggests that transcranial magnetic stimulation is safe for influencing brain activity?

Research has shown that transcranial magnetic stimulation (TMS), particularly theta burst stimulation (TBS), has been studied for safety in conditions like memory and thinking problems. Studies suggest that TMS is usually well-tolerated, with few serious side effects. The most common side effects are mild, such as headaches or scalp discomfort.

Reports on theta burst stimulation emphasize the need to monitor for any side effects but do not highlight any major safety issues. This suggests that TBS is fairly safe when used at the right intensity. However, participants should discuss any concerns with the study team to fully understand potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial magnetic stimulation (TMS) for episodic memory because it offers a non-invasive way to potentially enhance brain function. Unlike traditional treatments for memory issues, which often involve medications, TMS uses magnetic fields to stimulate specific brain regions directly. This means it can target areas associated with memory more precisely without the systemic side effects that drugs might cause. Additionally, continuous theta-burst stimulation, a form of TMS used in this trial, is designed to produce effects more quickly and with shorter session durations compared to standard TMS protocols. This innovative approach could lead to faster improvements in memory and cognitive function.

What evidence suggests that transcranial magnetic stimulation is effective for episodic memory?

Research has shown that transcranial magnetic stimulation (TMS) can improve memory. In several studies, 83% of participants experienced enhanced memory, decision-making, and overall thinking skills after TMS treatment. This trial will administer a specific type of TMS, called continuous theta-burst stimulation, which has been found to reduce mind wandering and affect brain networks, potentially aiding in recalling past events. By targeting specific brain areas, TMS might strengthen the brain's natural connections and boost memory. These findings suggest TMS could be a promising method to enhance memory in healthy individuals. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy, right-handed adults aged 18 to 35 who speak English fluently and have normal vision (with or without correction). It's not suitable for those with major neurological or psychiatric illnesses.

Inclusion Criteria

Fluent in English

Right-handed

I do not have any major neurological or psychiatric illnesses.

Exclusion Criteria

I am currently experiencing severe lack of sleep, extreme tiredness, or have recently traveled across time zones.

I have a history of heart disease.

History of a learning disorder (e.g., attention deficit disorder, dyslexia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

MRI Session

Participants undergo an MRI session for collecting structural and functional brain images

1 session

1 visit (in-person)

Stimulation and Testing

Participants receive transcranial magnetic stimulation followed by MRI and memory tasks

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial magnetic stimulation

Trial Overview The study tests how transcranial magnetic stimulation (TMS) affects brain activity related to episodic memory. Participants will undergo TMS, behavioral testing, and MRI scans to see how this influences memory and brain network interactions.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 1 Intervention

All participants will complete all experimental conditions, which include transcranial magnetic stimulation (continuous theta-burst stimulation) to a brain region of experimental interest and to a control brain region.

Who Is Running the Clinical Trial?

Boston College

Lead Sponsor

Trials

40

Recruited

49,300+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) has a very low seizure risk, with only 0.08 seizures reported per 1,000 sessions, and less than 0.02 seizures per 1,000 sessions when guidelines are followed for individuals without known risk factors.

The study found that exceeding safety guidelines increases the risk of seizures, and seizures are more likely to occur during the first few TMS sessions, suggesting that TMS is generally safe when administered properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Lerner, AJ., Wassermann, EM., Tamir, DI.[2021]

Mild adverse effects (MAEs) from transcranial magnetic stimulation (TMS) occur in about 5% of sessions, with most symptoms like headache and nausea reported after the sessions, particularly during initial treatments.

The study found no significant links between participant characteristics (age and gender) or TMS parameters (frequency and intensity) and the occurrence of MAEs, suggesting that initial participant anxiety may play a role in these reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. Maizey, L., Allen, CP., Dervinis, M., et al.[2022]

In a study involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Repetitive Transcranial Magnetic Stimulation (rTMS) shows promise in enhancing cognitive processes, particularly in patients with epilepsy, by helping to identify verbal memory lateralization and potentially improving memory performance.

Single-pulse TMS is effective for mapping motor output during learning, while rTMS can interfere with the retrieval of episodic and semantic memories, indicating its potential as a valuable tool for studying learning and memory in cognitive neuroscience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation can measure and modulate learning and memory. Grafman, J., Wassermann, E.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has not been thoroughly studied for side effects, with the main known risk being the acute production of seizures.

While tissue damage from rTMS is unlikely, there are concerns about potential cognitive effects and the possibility of long-term changes in brain function that have not yet been fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. Wassermann, EM.[2005]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11177618/

Effects of continuous versus intermittent theta-burst TMS on ... These findings suggest that continuous theta-burst may have entrained the endogenous hippocampal-cortical network, whereas the intermittent train was unable to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S3050529125000972

Reducing mind wandering using continuous theta burst ... Continuous theta burst stimulation over angular gyrus reduced mind wandering. Active stimulation reduced behavioural variability compared to sham.

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

Efficacy and Safety of Transcranial Magnetic Stimulation on ... Five of the 6 studies (83%) reported improved memory, executive function, and global cognition with TMS. One study analyzing the TMS impact on ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1298065/full

Effects of repetitive transcranial magnetic stimulation on ... We aim to investigate the efficacy of rTMS on episodic memory in individuals with SCD, and to explore the potential mechanisms of neural plasticity.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04558164

NCT04558164 | Network-targeted Theta-burst Stimulation ... The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3260517/

Safety of Theta Burst Transcranial Magnetic Stimulation Additionally, this review highlights the need for rigorous documentation of adverse events associated with TBS, as well as intensity dosing studies to assess ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04558164

NCT04558164 | Network-targeted Theta-burst Stimulation ... Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT). Participant Group/Arm, Sham Comparator : Sham TBS.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01315587

Repetitive Transcranial Magnetic Stimulation and ... The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in ...