Using brain stimulation to improve learning and decision-making

Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

This study is testing if a type of brain stimulation can help healthy adults learn better and make smarter decisions.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06561828 on ClinicalTrials.gov

What this trial studies

This study aims to develop and validate non-invasive neuromodulation protocols using transcranial magnetic stimulation (TMS) to target cognitive functions related to learning and decision-making. Healthy volunteers aged 18 to 45 will participate in up to five experiments, each requiring multiple clinic visits lasting several hours. The study will assess how TMS can modulate brain activity and improve cognitive functions, with a focus on understanding the neural mechanisms involved. Participants will experience different types of TMS, including continuous and intermittent Theta Burst Stimulation.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy right-handed individuals aged 18 to 45 years.

Not a fit: Patients with neurological disorders or conditions that increase seizure risk will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to new treatments for individuals with substance use disorders by enhancing their decision-making and learning capabilities.

How similar studies have performed: While the use of TMS in cognitive enhancement is being explored, this specific approach targeting learning and decision-making in healthy individuals is relatively novel.

Eligibility criteria

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet the following criteria:

* Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals.
* In good general health based on the assessment of the MAI.
* Right-handed.

EXCLUSION CRITERIA:

Individuals who meet any of the following criteria will be excluded from participation:

* Any neurological disorder that would increase seizure risk from TMS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.
* Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).
* Current use (any use in the past two weeks, daily use for more than one week within past 3 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), anti or pro-convulsive action. This will be determined at the discretion of the MAI.
* Unable to undergo MRI or TMS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons.
* History of noise-induced hearing loss or tinnitus.
* Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessive-compulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI.
* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.
* Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months.
* Participation in any neuromodulation (e.g., TMS, tFUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.
* For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the protocol itself.
* Uncorrected impairments in visual acuity severe enough to affect task participation.
* Non-English speaking. Justification: Data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TMS and MRI procedures. The inability to effectively communicate TMS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
* Pregnancy. Justification: It is unknown whether MRI and TMS pose risks to fetuses.
* Any other condition that in the judgment of the investigators is incompatible with participation.

Where this trial is running

Baltimore, Maryland

• National Institute on Drug Abuse — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Thorsten Kahnt, Ph.D. — National Institute on Drug Abuse (NIDA)
• Study coordinator: NIDA IRP Screening Team

Conditions: Normal Physiology, TMS, Decision Making, fMRI, Learning, Behavioral Tasks