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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT06868914
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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.

Detailed Description

Study Description:

This study is intended to test the safety and potential efficacy of the highdensity theta burst stimulation (hdTBS) paradigm. We hypothesize that hdTBS i) can be safely administered to normal healthy human subjects, and ii) can produce stronger and longer-lasting after-effects than the conventional FDA-approved TBS paradigm.

Objectives:

Primary Objective:

To determine whether hdTBS at the power level of 60% and 80% resting motor threshold can be safely administered to normal healthy human participants.

Secondary Objective:

To determine whether hdTBS produces stronger and longer-lasting after-effects than the conventional, FDA-approved TBS protocol. Here "after-effects" are defined as alterations in cortical excitability after TMS administration, which can be quantitatively assessed by measuring motor-evoked potential (MEP) before and after an acute session of TMS on the primary motor cortex. Changes in the characteristics and durations of the MEP signal relative to pre-TMS baseline reflect neuromodulation effects of the TMS session.

Endpoints:

Primary Endpoint:

Clinically significant adverse events as collected on the Noninvasive Brain Stimulation (NIBS) monitoring questionnaire and evaluated by the MAI in combination with the serious adverse event reports.

Secondary Endpoints:

20 complete datasets at the 80% RMT hdTBS dose that are evaluable for after-effects of hdTBS.

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Status Verified: 2025-03-11
• Study First Posted: 2025-03-11
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-05-26
• Primary Completion: 2028-01-13
• Study Completion: 2028-01-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinically significant adverse events as collected on the Noninvasive Brain Stimulation (NIBS) monitoring questionnaire and evaluated by the MAI in combination with the serious adverse event reports.	4-5 weeks	As a phase I trial, 25 participants are a reasonable sample size for a preliminary assessment of the safety profile of the hdTBS paradigm.

Secondary Outcome Measures

Name	Time	Method
20 complete datasets at the 80% RMT hdTBS dose that are evaluable for after-effects of hdTBS.	4-5 weeks	20 complete datasets should give sufficient power to detect an effect. hdTBS produces stronger and longer lasting after-effects sets a solid foundation for future study in patients to investigate the efficacy of the new TMS paradigm.

Trial Locations

Locations (1)

National Institute on Drug Abuse; 🇺🇸 Baltimore, Maryland, United States