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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 43% 35 → 20 participants
See other at-risk trials from National Institute on Drug Abuse (NIDA)

Record History

The 50 most recent of 363 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Start date: Oct 13, 2026 to Oct 14, 2026
  2. Start date: Oct 12, 2026 to Oct 13, 2026
  3. Start date: Oct 11, 2026 to Oct 12, 2026
  4. Start date: Oct 8, 2026 to Oct 11, 2026
  5. Start date: Oct 7, 2026 to Oct 8, 2026
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Oct 6, 2026 to Oct 7, 2026
  2. Start date: Oct 5, 2026 to Oct 6, 2026
  3. Start date: Oct 4, 2026 to Oct 5, 2026
  4. Enrollment target: 20 to 40 Start date: Sep 20, 2026 to Oct 4, 2026 · Eligibility criteria expanded, about 18 words · Site contacts updated at 2 of 2 sites Show 3 more changesShow less
    • Start date: Sep 20, 2026 to Oct 4, 2026
    • Eligibility criteria expanded, about 18 words
    • Site contacts updated at 2 of 2 sites
  1. Enrollment increased: 20 → 40 participants Start date: Sep 17, 2026 to Sep 20, 2026v354 Show 1 more changeShow less
    • Start date: Sep 17, 2026 to Sep 20, 2026
  2. Start date: Sep 16, 2026 to Sep 17, 2026v353
  3. Start date: Sep 15, 2026 to Sep 16, 2026v352
  4. Start date: Sep 14, 2026 to Sep 15, 2026v351
  5. Start date: Sep 10, 2026 to Sep 14, 2026v350
  6. Start date: Sep 9, 2026 to Sep 10, 2026v349
  7. Start date: Sep 8, 2026 to Sep 9, 2026v348
  8. Start date: Sep 7, 2026 to Sep 8, 2026v347
  9. Study sites: 1 to 2 Start date: Sep 6, 2026 to Sep 7, 2026v346 Show 1 more changeShow less
    • Start date: Sep 6, 2026 to Sep 7, 2026
  10. Start date: Sep 3, 2026 to Sep 6, 2026v345
  11. Enrollment reduced: 35 → 20 participants Start date: Sep 2, 2026 to Sep 3, 2026v344 Show 1 more changeShow less
    • Start date: Sep 2, 2026 to Sep 3, 2026
  12. Start date: Sep 1, 2026 to Sep 2, 2026v343
  13. Enrollment target: 35 to 20 Start date: Aug 31, 2026 to Sep 1, 2026v342 Show 1 more changeShow less
    • Start date: Aug 31, 2026 to Sep 1, 2026
  14. Start date: Aug 30, 2026 to Aug 31, 2026v341
  15. Start date: Aug 27, 2026 to Aug 30, 2026v340
  16. Start date: Aug 26, 2026 to Aug 27, 2026v339
  17. Start date: Aug 25, 2026 to Aug 26, 2026v338
  18. Start date: Aug 24, 2026 to Aug 25, 2026v337
  19. Start date: Aug 23, 2026 to Aug 24, 2026v336
  20. Start date: Aug 20, 2026 to Aug 23, 2026v335
  21. Start date: Aug 19, 2026 to Aug 20, 2026v334
  22. Start date: Aug 18, 2026 to Aug 19, 2026v333
  23. Start date: Aug 17, 2026 to Aug 18, 2026v332
  24. Start date: Aug 16, 2026 to Aug 17, 2026v331
  25. Start date: Aug 13, 2026 to Aug 16, 2026v330
  26. Start date: Aug 12, 2026 to Aug 13, 2026v329
  27. Start date: Aug 11, 2026 to Aug 12, 2026v328
  28. Start date: Aug 10, 2026 to Aug 11, 2026v327
  29. Start date: Aug 7, 2026 to Aug 10, 2026v326
  30. Start date: Aug 6, 2026 to Aug 7, 2026v325
  31. Start date: Aug 5, 2026 to Aug 6, 2026v324
  32. Start date: Aug 4, 2026 to Aug 5, 2026v323
  33. Start date: Aug 3, 2026 to Aug 4, 2026v322
  34. Start date: Aug 2, 2026 to Aug 3, 2026v321
  35. Start date: Jul 30, 2026 to Aug 2, 2026v320
  36. Start date: Jul 29, 2026 to Jul 30, 2026v319
  37. Start date: Jul 28, 2026 to Jul 29, 2026v318
  38. Start date: Jul 27, 2026 to Jul 28, 2026v317
  39. Start date: Jul 26, 2026 to Jul 27, 2026v316
  40. Start date: Jul 23, 2026 to Jul 26, 2026v315
  41. Start date: Jul 22, 2026 to Jul 23, 2026v314
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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: This is a multi-site study conducted at the Biomedical Research Center, National Institute on Drug Abuse Intramural Research Program in Baltimore, Maryland and Olin Neuropsychiatry Research Center in Hartford, Connecticut. 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....
Trial Details
NCT Number NCT06868914
Lead Sponsor National Institute on Drug Abuse (NIDA)
Conditions Healthy Volunteers
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov