High-Density TBS for Healthy Adults

Recruiting in Palo Alto (17 mi)

Overseen byYihong Yang, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute on Drug Abuse (NIDA)

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Transcranial magnetic stimulation (TMS) uses magnetic pulses to affect brain activity. A type of TMS called theta burst stimulation (TBS) is approved to treat people with major depression. Researchers have developed a new form of TBS called high-density TBS (hdTBS). They hope hdTBS will work better than TBS. But first they need to test the new treatment in healthy adults. Objective: To test hdTBS in healthy adults. Also, to compare the aftereffects of hdTBS and TBS. Eligibility: Healthy adults aged 22 to 60 years. Design: Participants will have 5 clinic visits over 4 to 5 weeks. They must abstain from drugs and alcohol and limit caffeine before visits. At their first visit, participants will be oriented to TBS. They will wear a cap and earplugs. A device with round coils will be placed near their head. When a brief electric current passes through the coil, it generates a magnetic pulse that stimulates the brain. Participants may feel a pulling sensation on the skin under the coil. Their fingers may move involuntarily. At their next 4 visits, participants will receive either TBS or sham TBS. A sham TBS uses a low magnetic field to minimize the effects of the treatment. Participants will have 3 to 6 electrodes placed on 1 arm. These electrodes will measure the electrical activity in their muscles. Each TBS session will be videotaped. At every visit, participants will answer questions about their health, including substance use. They will perform 2 tasks to test their thinking skills. They will perform a test on a computer to test their reaction time.

Eligibility Criteria

This trial is for healthy adults aged 22 to 60 who are willing to avoid drugs, alcohol, and limit caffeine intake before clinic visits. They'll participate in a study involving a new form of brain stimulation therapy over several weeks.

Inclusion Criteria

Ability and willingness to provide written informed consent

I am generally healthy.

I am between 22 and 60 years old.

Exclusion Criteria

Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness lasting over 30 minutes or with sequela lasting longer than two days or other neurological condition deemed by the MAI to be likely to affect response to the TBS being delivered

A close family member has had migraines, epilepsy, or multiple sclerosis.

I have hearing loss or ringing in my ears due to loud noise.

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Treatment Details

Interventions

High-Density Theta Burst Stimulation (hdTBS) (Procedure)

Trial OverviewResearchers are testing high-density Theta Burst Stimulation (hdTBS) using the MagVenture MagPro TMS device. The goal is to see if hdTBS can affect brain activity more effectively than standard TBS in healthy individuals.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Active TBS (3-,4-, and 5-pulse TBS)Active Control1 Intervention

Each participant will receive 3 active TBS (3-,4-, and 5-pulse TBS) and 1 sham TBS on 4 visits separated by at least 48 hours to minimize any potential accumulating effects from prior visits.

Group II: Sham TBSPlacebo Group1 Intervention

Each participant will receive 3 active TBS (3-,4-, and 5-pulse TBS) and 1 sham TBS on 4 visits separated by at least 48 hours to minimize any potential accumulating effects from prior visits.