Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT06561828
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Normal Physiology

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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).
  • 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).
  • sham Theta Burst Stimulation (sham TBS) — DEVICE
    iTBS or cTBS delivered with placebo side of A/P coil.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Nov 1, 2044
Completion
Nov 2, 2044

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experiment 1
    Healthy volunteers in experiment 1
  • Experimental: Experiment 2
    Healthy volunteers in experiment 2
  • Experimental: Experiment 3
    Healthy volunteers in experiment 3
  • Experimental: Experiment 4
    Healthy volunteers in experiment 4
  • Experimental: Experiment 5
    Healthy volunteers in experiment 5

Primary Outcome Measure

Task Performance [ Time Frame: after each intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute on Drug AbuseBaltimoreMaryland21224
Thorsten Kahnt
[email protected]
667-312-5175

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By research site
National Institute on Drug Abuse· Baltimore, MD

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