Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-60
SponsorNational Institute on Drug Abuse (NIDA)

About 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 4 clinic visits over about 3 to 4 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 3 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 up to 9 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

Qualifiers

Be 22-60 years of age.

Ability and willingness to provide written informed consent.

Generally in good health.

Justification: Many illnesses may alter neural functioning. These will be evaluated by the MAI and excluded as needed.

Disqualifiers

Justification: Stroke or head trauma can lower the seizure threshold, and are therefore contra indications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures.

Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.

Justification: Any metal around the head is a contraindication for TMS, as it involves exposure to a relatively strong magnetic field.

Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS equipment.

Trial design

Treatments tested in this trial

  • TMS (MagVenture MagPro 100 with MagOption)

Treatment groups

35 Participants
are divided into 2 treatment groups

Locations

1
National Institute on Drug Abuse21224, BaltimoreMaryland, United States

Sponsors and collaborators

National Institute on Drug Abuse (NIDA)

Lead sponsor