Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

NCT06561828 | Recruiting Early Phase 1

• 2 other identifiers: 10001932001932-DA
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Background: People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to know how a technique called transcranial magnetic stimulation (TMS) may cause changes in brain activity that may help people with SUD. Objective: To test TMS in healthy volunteers. Eligibility: Healthy people aged 18 to 45 years who are right-handed. Design: Participants can volunteer for up to 5 different experiments. Each experiment requires 2 to 8 clinic visits. Each visit will last 3 to 7 hours. Some visits will include TMS. A coil will be placed on the participant s head. A brief electrical current will pass through the coil to create a magnetic field. Participants may feel a tapping or pulling sensation on the skin under the coil. They may feel a twitch in their face, neck, arm, or leg muscles. Participants may be asked to tense certain muscles during TMS. Some visits will include functional magnetic resonance imaging (fMRI) scans. Participants will lie on a bed that slides into a large tube. They will perform tasks on a computer inside the tube. The fMRI will show which parts of the brain are used during each task. Participants will perform tasks on a computer. Some tasks may be done at a desk as well as during TMS and fMRI. Participants may look at images, listen to sounds, smell odors, or taste flavored liquids. Their vital signs may be monitored and their eye movements may be tracked during tasks.

Conditions

Normal Physiology

Keywords

TMS; Decision Making; fMRI; Learning; Behavioral Tasks

Outcome Measures

Primary Outcomes (1)

• Task Performance

  Responses on behavioral tasks

  after each intervention

Study Arms (5)

Experiment 1

EXPERIMENTAL

Healthy volunteers in experiment 1

Device: continuous Theta Burst Stimulation (cTBS); Device: intermittent Theta Burst Stimulation (iTBS); Device: sham Theta Burst Stimulation (sham TBS)

Experiment 2

EXPERIMENTAL

Healthy volunteers in experiment 2

Device: continuous Theta Burst Stimulation (cTBS); Device: intermittent Theta Burst Stimulation (iTBS); Device: sham Theta Burst Stimulation (sham TBS)

Experiment 3

EXPERIMENTAL

Healthy volunteers in experiment 3

Device: continuous Theta Burst Stimulation (cTBS); Device: intermittent Theta Burst Stimulation (iTBS)

Experiment 4

EXPERIMENTAL

Healthy volunteers in experiment 4

Device: continuous Theta Burst Stimulation (cTBS)

Experiment 5

EXPERIMENTAL

Healthy volunteers in experiment 5

Device: continuous Theta Burst Stimulation (cTBS); Device: sham Theta Burst Stimulation (sham TBS)

Interventions

continuous Theta Burst Stimulation (cTBS) DEVICE

Continuous theta burst stimulation (three TMS pulses delivered at 50Hz with the bursts delivered at 5Hz for a total of 600 pulses per site).

Experiment 1; Experiment 2; Experiment 3; Experiment 4; Experiment 5

intermittent Theta Burst Stimulation (iTBS) DEVICE

Intermittent theta burst stimulation (three TMS pulses delivered at 50Hz with the bursts delivered at 5Hz for 2 seconds followed by a break of 8 seconds for a total of 600 pulses per site).

Experiment 1; Experiment 2; Experiment 3

sham Theta Burst Stimulation (sham TBS) DEVICE

iTBS or cTBS delivered with placebo side of A/P coil.

Experiment 1; Experiment 2; Experiment 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

• Thorsten Kahnt, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIDA IRP Screening Team

CONTACT

(800) 535-8254; researchstudies@nida.nih.gov

Thorsten Kahnt, Ph.D.

CONTACT

(667) 312-5175; thorsten.kahnt@nih.gov

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): November 1, 2044
• Study Completion (Estimated): November 2, 2044
• Last Updated: May 6, 2026

Record last verified: 2026-04-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)