NOT_YET_RECRUITING

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

Conditions

Healthy Volunteers Substance Use Disorders (SUDs)Transcranial Magnetic Stimulation (TMS)Theta Burst Stimulation (TBS)High-density Theta Burst Stimulation (hdTBS)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Phase I Clinical Trial to Study the Safety and After-effects of Transcranial Magnetic Stimulation (TMS) Using A High-density Theta Burst Stimulation (hdTBS) Paradigm

Quick Facts

Study Start:2026-02-09

Study Completion:2028-01-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:NOT_YET_RECRUITING

Study ID

NCT06868914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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. * Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS. * Justification: The population of interest here is a healthy control population with no psychiatric disorders. In participants with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms. * Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required. * Justification: Excessive caffeine use can reduce seizure threshold and could potentially increase risk of TMS-induced seizure. * Justification: The population of interest is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS. * Justification: the population of interest is a healthy control population with no present or past substance use disorder. * Justifications: the risk of TMS for individuals with a heart condition is unknown. * Justification: it is unknown whether TMS poses a risk to fetuses. * Justification: in order to limit exposure to TMS, we will not enroll participants who have received TMS less than two weeks ago.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.
* Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS.
* Justification: The population of interest here is a healthy control population with no psychiatric disorders. In participants with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms.
* Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required.
* Justification: Excessive caffeine use can reduce seizure threshold and could potentially increase risk of TMS-induced seizure.
* Justification: The population of interest is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS.
* Justification: the population of interest is a healthy control population with no present or past substance use disorder.
* Justifications: the risk of TMS for individuals with a heart condition is unknown.
* Justification: it is unknown whether TMS poses a risk to fetuses.
* Justification: in order to limit exposure to TMS, we will not enroll participants who have received TMS less than two weeks ago.

Contacts and Locations

Study Contact

Yihong Yang, Ph.D.

CONTACT

(667) 312-5364

yihongyang@intra.nida.nih.gov

Principal Investigator

Yihong Yang, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Study Locations (Sites)

National Institute on Drug Abuse

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: National Institute on Drug Abuse (NIDA)

Yihong Yang, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Drug Abuse (NIDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2026-02-09

Study Completion Date2028-01-13

Study Record Updates

Study Start Date2026-02-09

Study Completion Date2028-01-13

Terms related to this study

Keywords Provided by Researchers

Substance Use Disorders (SUDs)
Transcranial Magnetic Stimulation (TMS)
Theta Burst Stimulation (TBS)
High-density Theta Burst Stimulation (hdTBS)

Additional Relevant MeSH Terms

Healthy Volunteers