Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a technique called transcranial magnetic stimulation (TMS) to see if it can change brain activity in ways that might help individuals with substance use disorder (SUD). However, in this study, researchers are testing TMS on healthy volunteers aged 18 to 45 who are right-handed, to better understand how it works before applying it to those with SUD.

Participants can take part in up to five experiments, each requiring 2 to 8 visits to the clinic. During these visits, participants will undergo TMS, where a device will be placed on their head to create a magnetic field, and they might feel a tapping sensation. They will also participate in brain scans using functional magnetic resonance imaging (fMRI) while doing various tasks on a computer. Throughout the study, participants' vital signs will be monitored. It's important to note that certain health conditions and recent substance use may disqualify individuals from participating, so eligibility is carefully evaluated.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• In order to be eligible to participate in this study, an individual must meet the following criteria:
• • Willingness to comply with all study procedures and availability for the duration of the study. Consent signature will be documentation of meeting this criterion.
• • 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.
• • Agreement to adhere to Lifestyle Considerations throughout study
• • duration. Consent signature will be documentation of meeting this criterion.
• • -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.