What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is generally well-tolerated, but some common side effects include mild headaches, scalp discomfort at the stimulation site, and tingling or twitching of facial muscles. Rare but more serious side effects can include seizures, particularly in individuals with a history of epilepsy. Other neuromodulation treatments, such as vagus nerve stimulation and transcutaneous electrical nerve stimulation, may cause mild adverse effects like skin irritation, muscle spasms, and transient pain at the application site. Overall, these treatments are considered safe with a low incidence of serious adverse events.

What prior FDA approvals exist?

Transcranial Magnetic Stimulation (TMS) has been FDA-approved for various conditions, including major depressive disorder and migraine. TMS modulates neural activity in targeted brain regions and has shown efficacy in clinical trials for these conditions. Other neuromodulation therapies, such as electroconvulsive therapy (ECT) and vagus nerve stimulation (VNS), are also FDA-approved for treatment-resistant depression and epilepsy, respectively. These treatments, like TMS, aim to alter brain activity to achieve therapeutic effects.

What other types of research exist?

Promising, novel alternatives to Transcranial Magnetic Stimulation (TMS) for modulating neural activity in healthy subjects include Transcutaneous Supraorbital Nerve Stimulation and Remote Electrical Neuromodulation. Both methods have shown efficacy in clinical trials for reducing pain intensity and modulating neural activity, making them potential alternatives for research and therapeutic applications in 2024.

← Back to Search

Behavioural Intervention

TMS Stimulation for Healthy Subjects

N/A

Recruiting

Led By Regina Lapate, Ph.D.

Research Sponsored by University of California, Santa Barbara

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18 and 45

Be between 18 and 65 years old

Must not have

History of seizures

Current or prior diagnosis of a psychiatric disorder requiring hospitalization and/or currently using psychiatric medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 12-14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses brain scans and magnetic stimulation to study how healthy people's brains process emotional and time-related information to guide actions.

Who is the study for?

This trial is for healthy individuals interested in participating in a study that examines how the brain processes emotional and temporal information. Participants should be willing to undergo fMRI scans and transcranial magnetic stimulation (TMS). Specific eligibility criteria are not provided.

What is being tested?

The study is testing how certain brain regions track emotional and time-related information from dynamic events, using fMRI scans while participants view images. The goal is to understand how this informs actions. TMS will be used to explore the causal role of these regions.

What are the potential side effects?

While specific side effects are not listed, typical side effects of fMRI include discomfort from lying still during scanning. TMS may cause mild headaches or scalp discomfort at the stimulation site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures.

Select...

I have been hospitalized for a psychiatric disorder or am on psychiatric medication.

Select...

I have a history of or currently have a neurological condition.

Select...

I have a history of fainting.

Select...

I have a family history of epilepsy or seizures.

Select...

I have had surgery that involved metal implants or devices like a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 12-14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 12-14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12-14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Behavioral response

Multivariate BOLD metrics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Duration difference estimationExperimental Treatment3 Interventions

Participants will view emotional sequences composed of four emotional images. They will be asked to indicate whether the total duration of positive or negative emotional events was longer, by responding with a button press to a contextual cue defining the relevant action (Left vs Right button). The amount of temporal evidence in favor of one valence in a 12-s sequence is varied orthogonally with respect to the (predominant) emotional valence by varying individual picture presentation times. Participants will undergo one fMRI session and 3 TMS+fMRI sessions (2 of the TMS sessions target prefrontal (PFC) sites, and 1 targets a non-PFC control site).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) works by generating a magnetic field that induces electrical currents in specific brain regions, modulating neural activity. This modulation can help infer the causal role of these brain regions in integrating emotional and temporal information, which is crucial for goal-directed actions. For healthy subjects, understanding these mechanisms is important as it can enhance cognitive functions, improve emotional regulation, and optimize decision-making processes, thereby promoting better overall mental health and daily functioning.